General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for the medical oversight of global pharmacovigilance activities of clinical trials and product development. 

Roles and Responsibilities

• Provide guidance for the development of worldwide pharmacovigilance strategies within Sage’s goals.
• Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department.
• Perform or provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
• Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
• Ensure ongoing evaluation of the overall safety profile for Sage’s investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
• Support both Medical Science and Clinical Operations teams with respect to safety related issues as required.
• Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents, as needed.
• Support development and maintenance of product benefit-risk profile.

Qualifications: 

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

• M.D. degree
• General knowledge of pharmaceutical development and a minimum of 5 - 7 years of experience in Safety/Pharmacovigilance in a global environment.
• Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
• Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
• Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.
• Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
• Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker to oversee two or more high priority neuroscience development programs as they transition from candidate selection into early clinical development.  The ideal candidate will possess demonstrated program executive experience leading early to late stage drug development programs.

Roles and Responsibilities

• Define and articulate clear strategic vision  within program teams
• Operational leader for the product development/early development projects and serve as visible program champion and focal point for critical program information
• Responsible for the management and delivery of an integrated development plan for the compound(s) and ensuring alignment across strategic, operational and tactical plans
• Set and maintain focus on overall program objectives and milestones but knowledgeable of supporting detail (tasks, associated expert resources and expense).
• Drives decision point planning and associated deliverables across all functions of the team and contributes to the Sage portfolio planning process on behalf of the program(s)
• Ensures the input from sub-teams to support the advancement of the program’s objectives and deliverables
• Perform full program planning and execution within team environment
• Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses and ensure accurate information is provided for planning processes and resource allocation
• Proposes resource needs for Program
• Develop and own budget projections and timelines to establish annual goals and to scenario plan across multiple programs in collaboration with cross-functional departments.
• Program Status Reporting - ensure program is viable and aligned with corporate strategy
• Accountable for meeting targets and managing deliverables
• Issue Identification and Resolution
• Cross-Functional Coordination and Communication including senior management
• Demonstrate and apply understanding of the interdependencies between various stakeholders within the drug development process including but not limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development program.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

• Advanced degree and 15+ years of multi-disciplinary experience in the biotech/pharmaceutical industry with 8+ years of direct project/program management experience in preclinical and clinical development, ideally honed through a combination of portfolio prioritization, working within a medical affairs organization (or similar) with emphasis on discovery to early development transition
• Demonstrated knowledge of overall drug discovery and drug development processes relevant to pharmaceutical/biotech organizations as evidenced by multiple successful drug discovery program leadership experience
• Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
• Capable of managing multiple programs/brands simultaneously
• Previous experience with portfolio management concepts preferred; must have advanced planning and tracking skills with attention to detail including experience with project management and tools (i.e., MS Project)
• Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
• Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicine to patients.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.
• Possesses strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for broad executive administrative support. 

We are actively seeking a dynamic, pro-active Executive Assistant. In this position, you will be an integral contributor to the team, acting as the organizational and communication hub for the department and working collaboratively with other departments.

Roles and Responsibilities

• Coordinates executive calendar, meetings, schedule, travel arrangements, expense reports and prepares necessary materials.  Consults with executives as needed to solicit information, provide critical updates and to coordinate information and priorities. Exercises tact, diplomacy and discretion in written and verbal communications.
• Plans, organizes and compiles data.  Analyzes needs and problems, researches facts, determines approach, and organizes and coordinates information retrieval and documentation procedures. Exercising creativity, initiative and an understanding of the executive’s and departmental objectives.  May independently prepare communications, budgets or data. Ensures accuracy of data and sources, and researches questions or problems demonstrating a sound knowledge of the technical specialty area(s) and general corporate policies and operations.
• Independently performs special projects that require a combined knowledge of administrative needs and technical operations.  Selects appropriate resources and analyzes data as required i.e. budget projects, Advisory boards, event planning etc. Develops recommendations for executive approval and may assist with the implementation of contractual agreements or compliance activities.
• Responds to a wide variety of requests for information, policies and procedures, and executive action. Analyzes needs and problems, and determines approach and priority. Exercises tact, discretion, and an understanding of technical and organizational materials, issues and impact. Takes initiative to research technical or outside of policy questions. Evaluates and refers matters for appropriate handling, and coordinates, compiles and documents relevant data and background information to support executive decision making or problem resolution. Works with highly sensitive, time sensitive and confidential information
• Provide back-up administrative support to other departments as necessary and other duties as required.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Strong analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues.

• Prior executive assistant experience working in a busy, high-growth and fast-paced environment.
• AS Degree with 5-7 years related experience, or BA/BS plus 3-5 years related experience.
• Strong computer skills, in particular Microsoft Outlook, Word, Excel and PowerPoint.
• Administrative competence (typing, scheduling, e-mailing, coordinating calendars, copying)
• Top-notch organization skills with strong attention to detail.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Possesses strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for broad executive administrative support. 

We are actively seeking a dynamic, pro-active Executive Assistant. In this position, you will be an integral contributor to the team, acting as the organizational and communication hub for the department and working collaboratively with other departments.

Roles and Responsibilities

• Coordinates executive calendar, meetings, schedule, travel arrangements, expense reports and prepares necessary materials.  Consults with executives as needed to solicit information, provide critical updates and to coordinate information and priorities. Exercises tact, diplomacy and discretion in written and verbal communications.
• Plans, organizes and compiles data.  Analyzes needs and problems, researches facts, determines approach, and organizes and coordinates information retrieval and documentation procedures. Exercising creativity, initiative and an understanding of the executive’s and departmental objectives.  May independently prepare communications, budgets or data. Ensures accuracy of data and sources, and researches questions or problems demonstrating a sound knowledge of the technical specialty area(s) and general corporate policies and operations.
• Independently performs special projects that require a combined knowledge of administrative needs and technical operations.  Selects appropriate resources and analyzes data as required i.e. budget projects, Advisory boards, event planning etc. Develops recommendations for executive approval and may assist with the implementation of contractual agreements or compliance activities.
• Responds to a wide variety of requests for information, policies and procedures, and executive action. Analyzes needs and problems, and determines approach and priority. Exercises tact, discretion, and an understanding of technical and organizational materials, issues and impact. Takes initiative to research technical or outside of policy questions. Evaluates and refers matters for appropriate handling, and coordinates, compiles and documents relevant data and background information to support executive decision making or problem resolution. Works with highly sensitive, time sensitive and confidential information
• Provide back-up administrative support to other departments as necessary and other duties as required.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.  Strong analytical skills and an ability to communicate issues in a simple way and to orchestrate plans to resolve issues.

• Prior executive assistant experience working in a busy, high-growth and fast-paced environment.
• AS Degree with 5-7 years related experience, or BA/BS plus 3-5 years related experience.
• Strong computer skills, in particular Microsoft Outlook, Word, Excel and PowerPoint.
• Administrative competence (typing, scheduling, e-mailing, coordinating calendars, copying)
• Top-notch organization skills with strong attention to detail.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Possesses strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

GENERAL OVERVIEW:

The Head, Global Market Access (GMAx) will establish a best in class, fit for purpose global market access capability for Sage Therapeutics’ expanding pipeline and ensure market access readiness and successful launch and commercialization of the product portfolio.  The GMAx function will be instrumental in substantiating and maintaining the long-term value of our therapies to patients, payers, healthcare policy & reimbursement decision makers, and other critical access stakeholders.  This position will be responsible for leading the development and execution of pricing, reimbursement and market access strategies for our pipeline portfolio by successfully partnering and coordinating with key internal stakeholders, including clinical development/R&D, Commercial, and regional leadership, as well as external customers and key stakeholders.

The needs of GMAx will evolve over time as Sage Therapeutics nears product launch phase and expands the product portfolio.  The Head, Global Market Access will be responsible for developing and implementing a roadmap for GMAx that ensures a systematic process that leads to a compelling value proposition for Sage Therapeutics’ products and launch readiness.  This roadmap will also address the necessary resources as well as organizational considerations of the GMAx function in order to maximize commercial success and lead to optimal patient access to Sage Therapeutics’ pipeline and in-line products.

SCOPE:

The Head, Global Market Access (GMAx) will provide leadership and strategic direction in developing global (US and International) market access efforts for all pipeline and product launches, including lifecycle planning and eventually the management of marketed (in-line) products the Sage Therapeutics’ portfolio in order to ensure achievement of business objectives and product availability to patients.

KEY RESPONSIBILITIES

The Head, Global Market Access (GMAx) will lead global market access strategy development and implementation in areas of:

• Strategic and tactical pricing
• Reimbursement strategy
• Payer value proposition (including value demonstration data and core value messages, input on clinical endpoints, patient population, epidemiology, unmet needs analysis, target product profile input, etc.)
• Core value dossier
• Negotiation strategy

 Specifically, the Head, Global Market Access (GMAx) will:

• Design and implement Sage Therapeutics product reimbursement strategy, programs, and policies for pipeline and in-line products.
• Provide strategic insights and oversight of market access policy environmental shaping initiatives to ensure Sage Therapeutics competitive position in markets globally.
• Understand the global market access environment, trends, and interdependencies of the channel and payer market dynamics strategies to maximize profitability across portfolio.
• Lead market access input into investment decisions and trade-offs to help inform and drive portfolio decisions.
• Represent Sage Therapeutics to key external market access customers and key stakeholders globally, including payers, patient organizations, and policymakers, developing trusting relationships and deep understanding of their needs and requirements.
• Ensure payer and policy maker needs are properly considered in the commercial brand plans, strategies and initiatives.
• Provide direct oversight on localization and execution of Global Market Access strategy across markets globally.
• Monitor progress and performance against strategy and plans.

As Sage Therapeutics grows, the product pipeline matures and needs evolve, the Head of Global Market Access will be charged with designing and building a best in class, fit for purpose GMAx function.  This will include:

• Develop and execute a long-term Global Market Access strategy and objectives that meet the evolving needs of the business, along with the capabilities, resources, processes and tools to support the business.
• Recruit and lead a team of market access professionals, providing strategic vision and operational excellence.
• Ensure appropriate people management and of GMAx talent (managing performance, people development, training, retention, and enabling a culture consistent with Sage Therapeutics’ core values).
• Establish value proposition model (including tasks for each development phase, launch and post launch), in collaboration and coordination with commercial function, that ensures alignment and integration with the global brand strategy and commercial strategies. 

EDUCATION & MINIMUM REQUIREMENTS:

• University degree in science or business required; advanced degree (MBA, MPH, PhD, MD) highly desirable.
• 15+ years pharmaceutical experience, with at least 10+ years of US and international market access responsibilities and successful track record operating in a global environment.  Deep technical expertise in the US and key international managed care markets, with particular emphasis in the European markets).
• Demonstrated hands-on experience and expertise in global market access aspects as it relates to orphan drugs and rare diseases strongly preferred. 

 TARGET HIRING DATE: November 1, 2015; no later than January 1, 2016

Principal Accountabilities

SAGE is seeking a highly-motivated leader with strong portfolio, program and project management skills to oversee the company’s product portfolio and to drive value creation and results. This role will lead the core team for SAGE’s lead program, oversee broader program management leaders for pipeline programs and will be responsible for the hands-on management of program operations. The individual will work collaboratively with the program teams to manage and integrate the diverse commercial activities and R&D of drug development through interactions with preclinical research, clinical operations, finance, CMC and manufacturing, medical affairs, regulatory affairs and commercial operations. This is an exciting and interdisciplinary role for a highly qualified and motivated individual.

Responsibilities

• Create SAGE’s first global project management and resource capacity planning capability in order to enhance the efficiency and effectiveness of SAGE’s matrix operating model, and support the company’s growth.
• Ensure sound project management practices and their consistent application across functions and product teams such that they support strategic decision making through global processes and tools that can routinely produce an integrated portfolio view of activity and resource information required to make optimal product, portfolio, and capacity planning decisions.
• Lead and drive program team(s) and is responsible for working closely with program team members to manage the operational aspects of the program(s), including monitoring key milestones, decision points and critical path activities to drive delivery of program objectives.
• Establish an approach/process to evaluate programs including criteria and metrics.  Ensure communications and adherence to the approach and process.
• Interface with relevant functional groups, coordinate the timely execution of program activities including anticipating and identifying any risks, mitigations and contingencies, and supporting timely action plans and issue resolution.
• Drive communication to align program activities with corporate strategy.
• Focus operations to deliver results by influencing team members beyond existing benchmarks and their own expectations.
• Prepare fully-integrated program timelines.
• Collaborate with key functions to map-out detailed long-range plans for successful product development and launch activities.
• Work with finance team and functional leaders to develop and track program budgets.
• Communicate effectively with all interfacing functions, Senior Management and external contractors.
• Develop, maintain, and deploy key project management tools and metrics. Ensure tools and metrics are used appropriately to enhance project and program delivery and information dissemination to the business.

Qualifications

The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with external stakeholders (research organization, clinical sites, manufacturing vendors, etc.).

• Outstanding leadership skills and demonstrated passion for creating new medicines, including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues.
• Ability to thrive in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential. 
• Advanced degree and 15+ years’ experience in life sciences industry, with 10+ years of demonstrated program management experience managing cross-functional product development efforts.
• Demonstrated project management skills; must have high degree of energy, accuracy and attention to detail.
• Ability to work independently and successfully in a matrix environment, and to prioritize and manage multiple tasks simultaneously.
• Ability to integrate cross-functional issues and balance competing priorities effectively.

GENERAL SUMMARY OF POSITION:

Under the direction of the Principal Investigator or designee, the Research Associate I performs a variety of complex research experiments, to include, but not limited to: working with animals, including anesthesia monitoring, drug administration (orally and injectable). Able to independently identify physiologic imbalances during anesthesia monitoring in surgical and imaging procedures. CVT certification is desired.

Other lab responsibilities include:

• Ability to prepare surgical suite, knowledge of commonly used instruments, and training in aseptic technique and sterilization procedures
• Demonstrated experience in pre-, peri- and post-operative support of animals. Ability to clinically assess animal condition
• Fluency with animal protocol compliance and review
• Experience maintaining controlled substances logs and inventory required
• Experience with necropsy and pathology reporting desired
• Experience in ordering supplies and maintaining inventory
• Experience in keeping equipment calibration and service logs

• Experience maintaining documentation regarding animal health, anesthesia, and surgical procedures required
• Familiarity with USDA / AAALAC regulations required

MAJOR RESPONSIBILITIES:

• Conducts in-depth analysis of research experiments
• Performs complex laboratory experiments
• Interprets data, forms conclusion, and decides on and plans next experiments to be done with a high degree of independence
• Compiles and analyzes data and performs computations using image analysis software, spreadsheets, graphing, and curve fitting software
• May modify protocols and be responsible for a single, independent research project
• Assists in writing the text of scientific publications and grants. Reviews literature
• Trains new laboratory personnel, students, and collaborators
• Maintains laboratory supplies and equipment
• Complies with all safety and infection control standards
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Biological Sciences, or equivalent experience
• 1 year relevant research experience
• Knowledge of Microsoft Office products
• Strong ability to analyze complex visual data in a quantitative and objective manner
• Judgment and action skills required to solve commonly encountered problems

PREFERRED QUALIFICATIONS:

• Ability to prepare surgical suite, knowledge of commonly used instruments, and training in aseptic technique and sterilization procedures
• Demonstrated experience in pre-, peri- and post-operative support of animals. Ability to clinically assess animal condition
• Fluency with animal protocol compliance and review
• Experience maintaining controlled substances logs and inventory required
• Experience with necropsy and pathology reporting desired
• Experience in ordering supplies and maintaining inventory
• Experience in keeping equipment calibration and service logs
• CVT certification is desired

SUPERVISION RECEIVED:

Under the direction of the Principal Investigator, or designee

SUPERVISION EXERCISED:

May functionally supervise Lab Technicians and Aides

ENVIRONMENTAL WORKING CONDITIONS:

Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.

Apply Here

PI92200496

General Scope and Summary

SAGE Therapeutics (www.sagerx.com) is seeking a highly-motivated, creative, resourceful, integrative thinker to join our growing Finance team.   This role will participate in many aspects of Financial Planning & Analysis for the company with immediate emphasis on building support for our expanding research and development and commercial organizations.   This individual will partner with key stakeholders with emphasis on maintaining transparency with the forecast and managing budget and forecast accuracy.  In addition, the candidate will be a contributor across the finance and the broader organization in leading and supporting initiatives to build a multi-product CNS company.

Roles and Responsibilities

• Effectively partner with leadership to develop strong financial management and analytical support
• Work closely with staff in Research and Development drive effective engagement, planning, decision making, and value thinking
• Lead efforts in implementing the latest systems and tools for managing the financial forecast and internal management reporting
• Support long-range planning, program analysis, business development, and financing activities through analysis and scenario modeling
• Partner with others in Finance & Accounting to ensure effective utilization of systems, application of excel models/tools, reporting and information sharing, and overall compliance with internal controls
• Support broader organization through ad hoc projects and analysis

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. 

• Bachelor’s degree and 5+ years of FP&A experience in a business partnering capacity; 
• Demonstrated strong collaborative and leadership skills and effective in working with cross-functional team members
• Excellent written and oral communication skills
• Demonstrated strong analytical skills and demonstrated ability to balance strategic thinking with bottoms-up detailed analysis
• Strong Excel skills and hands-on experience with financial analytics and modeling
• Strong knowledge of systems and tools for managing a financial forecast
• Strong experience in budgeting and forecasting including exposure to ERP planning and reporting
• Ability to manage multiple priorities simultaneously
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage 

Roles and Responsibilities

• Develop mutually beneficial relationships with external clients (physicians, scientific experts, hospital teams, educators and investigators) within a defined geography and internal business partners.
• Serve as the major representatives of SAGE for all key stakeholders, providing deep and advanced disease state and product information as well as facilitating the work of the stakeholders when it aligns with SAGE's mission.
• The MSL will be the primary point person liaising between SAGE resources or internal business partners (e.g., Clinical Research Report clinical insights and unanswered questions received from external contacts to the appropriate teams internally.
• Understand and effectively communicate current scientific knowledge.
• Maintain their disease state knowledge of Epilepsy and Refractory Status Epilepticus and treatment strategies to engage in deep scientific discussions.
• Engage in continuous learning within the therapeutic areas they represent.
• Attend appropriate scientific meetings, conduct routine literature searches, and will be expected to communicate regularly with each other to assure that the entire group benefits from individual learning whenever it is relevant.
• Establish oneself as a reliable, trusted, resource of accurate, up-to-date, medical and scientific knowledge that is requested and desired by their clients.
• Respond in a timely way to personal or electronic inquiries for information from SAGE, which may include reprints or posters, medical letters, literature citations, access to internal and external experts, slides and other teaching-related material.
• Effectively manage administrative activities
• The MSL job entails not only scientific and customer expertise, but also requires the ability to understand and effectively utilize approved resources to fulfill administrative, procedural, and legal requirements in order to address the customer needs. These activities may include proficiency in computer skills and database entry, continual compliance of all procedural requirements of the role (i.e. good documentation practices, standards and procedures,) and appropriate utilization and best practice sharing of available resources.
• The position is field-based with upwards of 60% required travel (car and plane) to manage assigned geography.
• Interactions with Payers - deal with Medical Directors within payer groups to discuss our science (disease state, epidemiology, diagnosis and treatment of SE/SRSE patients). Work in conjunction with members of the commercial team (i.e., Key Accts Mgrs, DM's and Reimbursement Managers) to communicate the merits of the science and the results of the clinical trials during pre-launch and launch.
• Partner with advocacy groups (I.e., Epilepsy Foundation, Dravet Syndrome Foundation, International Rett Syndrome Foundation, etc.).
• Conduct initial disease training of commercial personnel during the launch period, launch meetings, etc.
• Accountable to discuss and determine educational grant funding, ISS's (Investigator-sponsored studies), etc. in addition to the medical information and support requests.

Experience, Education and Specialized Knowledge and Skills

• PharmD, M.D., Ph.D. in Neurology/Neuroscience with 3-5 years of field medical experience (Epilepsy experience preferred).  Critical Care Nurse with deep epilepsy experience would be considered.
• Strong interpersonal skills, including capability to engage in professional relationship building and networking
• Sensitivity to the unique pressure of a hospital and academic center is needed.
• Experience working with epileptologists and neurocritical care experience preferred.
• Familiarity with the academic community and the medical research and medical education process highly valued.
• Intellectual curiosity and intelligence about the field of science/medicine for which they are responsible.
• Capable of translating complex scientific concepts into clear concise presentations to stake holders.
• Significant direct experience in servicing customer needs for complex information.
• Demonstrated ability to work with often demanding or difficult clients.
• Highly motivated, with significant experience and success in working independently, self-managing priorities and multi-tasking projects.
• Strong teamwork/interpersonal skills.
• Advanced presentation and computer skills with expertise in literature identification and evaluation.
• Significant experience in professional networking with positive mutually beneficial outcomes.
• Experience in field-based environments highly valued.
• Effective verbal and written communication skills.

Primary responsibilities include:

The Sr. Associate, Process Development (External Manufacturing) will focus mainly on process improvement activities for API and sterile drug product in support of the Manufacturing and Supply Chain organizations. This position is responsible for process development and development planning with domestic and international contract manufacturing organizations (CMOs).  Experience with batch records, SOPs, and investigations/CAPA.  Will work closely with CMC teams to implement new processes and manage changes. 

The position is responsible for:

• Partnering with CRO’s and CMO’s to develop products and cGMP processes
• Technical support of cGMP contract manufacturing for development, clinical, and commercial processes
• Responsible for coordinating  with internal teams and CMOs while managing tech transfer of manufacturing processes and process improvement initiatives
• Monitoring cGMP  compliance by reviewing production batch records with QA and escalating discrepancies to senior management as required
• Instituting corrective actions and best practices across all API and sterile drug product CMOs
• Feasibility assessment of new product and technology concepts
• Coordination of development activities with key partners across R&D and Manufacturing
• Manage scale-up and implementation for new products
• Be the person in plant during development, scale-up and routine production as necessary

Education and Skills Requirements: 

This role requires experience with product development and manufacturing, as well as experience working with CRO’s and CMOs.  Experience working with multiple cGMP manufacturing sites and/or contract manufacturers is desirable. 

• 4+ years of experience in the pharmaceutical, chemical, or related industry, with at least 2 years in a position directly related to pharmaceutical development and/or manufacturing
• Hands-on experience with various pharmaceutical unit operations including API manufacturing, formulation,  sterile fill finish, and labeling/packaging
• Technical knowledge of PMOs (phosphorodiamidate morpholino oligomers) based chemistry or similar is desired
• Manufacturing experience of either API including solid phase synthesis, purification, and lyophilization, and drug product formulation
• Knowledge of analytical techniques used for the characterization of morpholino oligomer (PMO) molecules including mass spectrometry (MALDI-TOF), and chromatography (RPIP-HPLC, SCX-HPLC)
• Experience with novel/alternate route drug delivery systems
• BA/BS required in Pharmaceutics, Chemistry, Chemical and/or Biomedical Engineering or related scientific discipline.  MSc/MBA preferred.
• Requires domestic and international travel

General Scope and Summary

SAGE Therapeutics is searching for a technical leader for a highly visible role as Sr. Director CMC development. The successful candidate will lead CMC product teams and collaborate closely with other functions including commercial manufacturing and supply chain to advance development compounds through clinical to commercial stage. This role is the 2nd hire for the SAGE Technical Operations team, and will partner closely with the SVP Technical Operations and other functions to build the team, organization and business processes to advance Sage’s fast growing portfolio of products.

Roles and Responsibilities

• Develops and oversees CMC product development strategy, planning and execution, and works closely with other functions including commercial manufacturing and supply chain
• Leads CMC teams and oversees CMC related development activities at external laboratories and manufacturing facilities
• Actively contributes to program teams, and ensures alignment of CMC activities with program development plans
• Owns and optimizes CMC related business processes
• Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results of the company

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of analytical science, chemical process development and formulation development, and a proven track record in CMC development for clinical stage programs. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must. Other requirements are:

• Advanced degree in Chemistry, Chemical Engineering or related field, PhD preferred
• 10+ years relevant small molecule CMC experience in the pharmaceutical industry
• Strategic view and leadership abilities as well as hands on problem solving skills
• Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 30% travel)
• Experience in writing regulatory documents and submissions
• Embraces our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of SAGE

General Scope and Summary

Oversee clinical development programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders. This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Director of Clinical Operations and Development.

Roles and Responsibilities

• Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
• Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
• Co-monitor or monitor studies if needed for the program
• Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
• Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
• Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed

Experience, Education and Specialized Knowledge and Skills

• Master’s degree preferred in a scientific or healthcare discipline
• Minimum of 5+ years in clinical and drug development in the pharmaceutical/biotech industry
• Understanding of drug development from pre-IND through NDA
• Extensive experience managing clinical programs, CROs, budgets, and timelines required
• Strong working knowledge of MS Project and developing Gantt charts
• Excellent oral, written, and medical communication skills required
• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
• Management of CROs, multiple vendors, and complex protocols
• Protocol, ICF, and CSR writing experience required
• A detailed understanding of overall strategic direction, interrelationships and business needs
• Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered
• Proven experience in the oversight of the operational aspects of all stages of clinical studies
• Ability to organize and manage multiple priorities required

Attributes

• Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Proactive and positive management approach
• Maximum flexibility to adapt to changing program needs in real time
• Strong leadership skills
• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Excitement about the vision and mission of Sage

SUMMARY

SAGE Therapeutics is seeking a Senior Medical Director to oversee the direction, planning, execution and interpretation of clinical trials/research and data collection activities.  The Medical Director will be a key contributor in building a medical function with both the depth and breadth to develop strategies that lead to global approvals of our products. Successful candidate will be responsible for creating clinical development plans and for successful execution against those plans. To be successful in this role, individual will be self-motivated, must have a strong work ethic and integrity. Additionally, individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.

The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment of an emerging start-up company that depends on strong links and collaboration with contract research organizations, academia and nonprofit organizations.

Responsibilities

• Overall accountability for design and implementation of clinical studies, writing clinical protocols and major amendments, design of data collection systems and preparation of final clinical study reports.
• Represents Medical Science on assigned Product Development Team(s), providing medical input to overall development planning and implementation.
• Responsible for directing human clinical trials, phases I–IV, for company products under development.
• Responsibilities also include adverse event reporting and safety responsibilities. 
• Coordinates and develops information for reports submitted to regulatory authorities.  Authors and/or reviews appropriate regulatory documents.
• Monitors adherence to protocols and determines study completion. 
• Engage with KOL for design of clinical trials and programs.
• Overall accountable to maintain the assessment of benefit/risk
• Ability to manage external organizations

 Desired Skills and Experience

Successful candidate must thrive working in a fast paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential. Must excel in a multidisciplinary environment as an integral leader and team member across several project teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Excellent written and verbal communication skills, strong problem solving ability, and attention to detail and quality are critical to success.

• Specific requirements include but are not limited to:
• Medical degree and 10+ years broad bio/pharmaceutical industry experience in drug development – Phase 1 through launch.  NDA experience strongly preferred
• Knowledge of Neurology, Anesthesia and/or Psychiatry.  
• Orphan drug/fast-track experience highly preferred
• Knowledge of the drug development process; strong understanding of technical, business and regulatory issues.
• Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and brining medicine to patients.
• Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company. 
• Able to command respect from peers and subordinates alike, capable of highly-independent work as well as being a team player and role model.  Key ability to interface with clinical operations.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the Company. 
• Ability to work independently as well as part of a team environment
• Proven ability to manage multiple projects, identify and resolve issues
• Ability to influence without authority, lead change and manage resistance to change.
• Must be able to solicit information, persuade others and shape outcomes.
• Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CRO
• Excitement about the vision and mission of Sage
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

The Position:

The Quality Control Associate Manager (QCAM) supports the Quality Control department in the planning, execution and management of in-house and outsourced (Contract Test Laboratories – CTLs) analytical testing activities for raw materials, DS and DP. The QCAM will set up a new QC laboratory and conduct laboratory experiments and maintain records of such experiments at Sarepta sites in Cambridge and Andover. The QCAM will also provide support to manage contract laboratory activities such as: review of method validation/transfer protocols and reports, compilation of and writing of development reports, tracking method development and testing at contract testing sites.  He/she must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GLP in all tasks.  Strong organizational skills are required, as well as the ability to balance changing priorities.   

Primary Responsibilities Include:

• Assist in setting up and manage the cGMP QC/Analytical laboratory
• Maintaining equipment and associated software in the laboratory in an up to date manner
• Develop and deploy laboratory documents such as SOPs, laboratory protocols (development and validation)
• Maintain laboratory notebooks and other written documents
• Interact with Contract testing laboratory (CTL) facilities
• Assist in developing qualification and validation protocols, qualification and validation reports
• Assist in managing completion of laboratory activities in CTL
• Review data and provide feedback to external and internal customers

Education and Skills Requirement:

• Bachelor’s degree or Masters degree in life sciences
• 5+ years’ experience in a direct laboratory setting and analyzing samples
• Demonstrable experience in method development and method validation for Oligonucleotide analysis methods
• Highly skilled in operating Waters, Agilent, Dionex HPLC instruments and MS detectors
• Strong computer skills including knowledge of Empower, ChemStation, Excel, Word, PowerPoint and Outlook  
• Solid understanding of cGMP requirements. Experience in working in a cGMP location is highly desired.
• Proven ability to work independently and effectively handle multiple priorities is a must.
• Ability to maintain confidentiality of proprietary information expected.
• A good team player that takes initiative to complete tasks diligently and correctly.
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
• Proficient written and verbal communication skills.
• Position may require some travel.
• Experience with Contract Test Laboratories a plus

The Position:

This position supports Quality Control and stability data oversight of Sarepta in-house and outsourced Contract Test Laboratories (CTLs) in support of GMP compliance. The individual will assist in monitoring, compiling and reviewing data with other members of a team.  The individual will also assist in managing quality events, review of quality documents such as protocols, reports and other quality documents.  The individual will ensure that all data and procedures are in concordance with the Sarepta Quality System and are error free.

Primary Responsibilities Include:

• Review of release and stability data and certificates of analysis received from CTLs
• Assist in managing projects at the CTL sites and managing the work flow and priorities
• Assist in writing and reviewing protocols, reports and other regulatory documents such as SOP, OOS/OOT and CAPA at vendor sites
• Assist in transferring assays to vendor sites and managing life cycle of those documents
• Experience in managing aspects of a stability program is an added qualification
• Deep understanding and work experience in a cGMP environment is added qualification

Education and Skills Requirement:

• MS with 2 years or BS with 5 years in Chemistry or related science field
• 3-5 years in a QC/Stability environment cGMP preferred
• Experience with laboratory equipment operation namely HPLC, GC, LC-MS, KF, pH and an understanding of CCIT, Microbiological testing
• Attention to details is a must
• Strong organizational skills
• Effective written and verbal communication skills
• Operate independently or as a part of a team, experience training individuals in a laboratory environment
• Experience in working in a CTL is highly desired
• Position may require some travel.

Summary

Sr. Project Manager, New Facility Build will be responsible for the overall coordination, implementation, execution, control and completion of capital and expense projects ensuring consistency with business strategy, commitments and goals. The individual will lead and drive the project management function supporting capital and expense projects involving planning, design, reconfiguration or construction of company buildings, structures, aseptic manufacturing /production areas, warehousing facilities, laboratories, offices, utilities, systems, equipment, automation/controls as well as technology transfers.
    

Responsibilities and Tasks

• Manage and coordinate major capital investment projects, specifically a new aseptic pharmaceutical manufacturing facility.
• Obtain agreement on project definitions, scope, and priorities, and ensures that resources, capabilities and processes are in place for proper sponsorship and governance.
• Provide routine status reports defining project progress, problems and solutions
• Present projects to senior management stakeholders
• Allocate resources, assign priority to tasks and direct multifunctional teams to achieve ongoing projects within established timelines and budgets.
• Define project tasks and resource requirements and may be required to develop full scale project plans.
• Track project deliverables using appropriate tools
• Define, identify and secure appropriate internal and external resources and coordinate the efforts of project managers and third-party contractors or consultants in order to deliver projects according to plan.
• Ensure that programs stay on plan by resolving resource conflicts and removing obstacles, which may involve negotiating at a senior level
• Utilize specific industry knowledge and leadership skills to direct ongoing engineering and validation projects
• Manage the development and implementation of process equipment, utilities, systems, and facilities improvements in conjunction with validation program and capital improvement projects.
• Manage the development of specifications and purchase of all capital equipment related to capital improvement projects.
• Manage external compliance and engineering firms to insure appropriate compliance requirements for equipment, utility, facility improvements/upgrades are met
• Manage capital and operating expense budgets and conducts project evaluations and assesses results
• Ensure that proper risk management analyses are performed and mitigation plans are in place for all projects implementations
• Ensure application of efficient work practices for project management processes and ensure continuous improvement and update of these practices by incorporating lessons learned
• Ensure generation and maintenance of accurate compliance control documentation.
• Responsible for development of standard practices, procedures and templates that will result in consistent, reproducible, scalable methodology for governance and life-cycle management of projects

Knowledge Skills and Abilities

• Extensive knowledge in aseptic filling and isolator experience required
• Strong knowledge of FDA, cGMP, ICH and engineering design standards
• Strong team leadership skills who exhibits a high level of initiative and self-motivation
• Demonstrated knowledge and expertise in bridging technical and business disciplines
• Ability to problem solve, provide leadership and direction
• Proven troubleshooting, problem solving and investigatory skills
• Skill in measurement, analysis, and continuous improvement of organizations
• Strong computer skills including engineering tools and applications
• Ability to plan, prioritize and organize diversified workload
• Excellent verbal, written and interpersonal communication skills

Education and Experience

• B.S. in Engineering or Project Management; Master’s degree preferred
• Minimum 5 years in pharmaceutical operations, with 2-3 years management experience and relative business experience in project and operations management including all aspects of new facility construction management from design through execution commissioning and validation  
• Prior experience managing capital projects and full working knowledge of project controls in cost, schedule development and financial assessments is required. PMP or comparable certification and familiarity with project management in the pharmaceutical industry are preferred.
• Direct experience and training on industry standards for aseptic manufacturing engineering and validation requirements
• Strong knowledge of cGMPs and applicability to facility design and start up  
• Possesses a full working knowledge of project management processes required in the design and execution of field construction activities including, but not limited to quality, project controls, and commissioning /qualification of FDA and other agency regulated facilities including regulations governing product manufacturing.
• Full understanding of project controls and financial assessments required for Capital Appropriation submissions.
• Knowledge of Quality by Design (QbD), Quality Risk Management (QRM) based on ICH Q8, Q9, and Q10 guidelines and experience with implementing systems
• Must be a team player prepared to lead, work in, and embrace a team-based culture.
• Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions.
• Ability to work in a fast-paced environment and handle multiple tasks simultaneously.

Pharmalucence is an Equal Opportunity Employer

Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you need help applying online, please contact joyce.robbins@sunpharma.com or call

Joyce, HR Assistant at 781-275-7120

In collaboration with cross-functional project team members and under the direction of the Therapeutic Clinical Operations Lead, the Senior Clinical Project Manager (Sr. CPM) will oversee operational aspects of one or more global clinical trials to successful completion within the prescribed timeframe and budget.  The Sr. CPM is responsible for compliance of clinical trials with local regulatory requirements, overall data quality and integrity, and human subject protection.

Responsibilities

• Develop and execute study plans for one or more global clinical trials with minimal supervision
• Select investigational sites with input from Clinical Development, Key Opinion Leaders, and vendors
• Review and refine investigator site manuals and clinical operations plans (e.g., study monitoring, communication, vendor management)
• Oversee investigator site adherence to pertinent regulations through review of monitoring reports, co-monitoring, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
• Participate in ongoing review of data to ensure quality and consistency
• Oversee the submission of trial-related and essential documents to the Trial Master File
• Assist with the preparation and management of investigator site contracts and vendor contracts for assigned study(ies)
• Participate in study budgeting and monthly cost accruals for assigned clinical trial(s)
• Manage study expenditures to study budget within the agreed variance
• Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices

• Anticipate potential study issues and prepare contingency plans with minimal oversight
• Communicate clinical study performance data to other members of the management and scientific team
• Plan and conduct investigator meetings, advisory boards, and data monitoring committees
• Contribute to the development and review of regulatory filings and key clinical documents including but not limited to the protocol, informed consent, case report form, investigator brochure, and clinical study report
• Oversee the Clinical Research Organization (CRO) and any additional third party vendors contracted to the clinical trial(s) 

Qualifications

• BA/BS in a scientific field of study with 5-7+ years of relevant experience working in Clinical Operations in the Pharmaceutical/ biotech industry or a CRO
• Rare-disease biologics experience preferred
• Understanding of industry standards and applicable guidelines; GCP and applicable FDA regulations knowledge
• The desire and ability to work in a fast-paced, start-up environment
• Strong collaboration, team-work, communication, and organizational skills required
• Up to 20% travel to clinical sites to supervise and coordinate clinical studies

It’s an exciting time to be at UMass Medical School! U.S. News & World Report ranks UMass Medical School 12th in the country for primary care, and this opportunity gives the right candidate the chance to be part of an elite academic and research institution that is among the most affordable in the country. As a member of our Information Technology Department, you will join a dynamic team of dedicated individuals committed to delivering forward thinking solutions with a focus on continuous improvement. At UMass Medical School IT we recognize and reward independent thought and innovative ideas. We have fostered an environment where the team dynamic is embraced and collaboration and FUN are core components of our culture!

We are seeking a dynamic Director of Data Management who will be responsible for leading a team charged with developing a novel infrastructure for integration and visualization of clinical data. Responsibilities include supervising teams to ensure the delivery of quality data and business intelligence needs, participating in the development and support of software systems. The Director will be responsible to plan, design, review, program, and implement new capabilities. The Director will also be responsible for demonstrating forward-looking views of how best to design databases that perform optimally and ensure security for sensitive data. They will also act as a thought leader on how to better utilize SQL/NoSQL architectures (as appropriate) to improve our ability to develop solutions rapidly and manage costs for enabling research discoveries!

MAJOR RESPONSIBILITIES:

• Oversee/coordinate the overall architecture, design, development, and maintenance of data warehousing and data visualization capabilities.
• Lead the development of the data warehousing and visualization roadmap; ensuring ongoing alignment of team's activities with the overall biomedical informatics strategy.
• Develop, initiate and maintain policies and procedures related to the clinical data warehousing in the organization in accordance with University of Massachusetts Medical School Policies and HIPAA guidelines.
• Manage creation of necessary architecture deliverables including data models, data flow diagrams and reference architecture.
• Manage strategic vendor relationships including platform vendors, support and development partners.
• Oversee existing platforms and processes to deliver efficient and effective services to meet the expectations developed with stakeholders. Identify areas of improvement for processes, technology and resources and implements these improvements
• Manage a technical team involving both functional and matrix resources that delivers technology solutions for business users
• Evaluate currently utilized and industry standard technologies as well as develop and improve standards for the consistent use of database, application, reporting, and technology services throughout the institution
• Play a leadership role in consulting with business units across UMMS to define business opportunities and map potential technology solutions to enable UMMS strategic direction. Maintain strategic focus on developing new functionality s to serve UMMS community and business partners
• Collaborate with the IT management and business partners in implementing secure and reliable solutions, make recommendations regarding development technologies, data systems, reporting tools and business intelligence platforms for new and ongoing projects and initiatives
• Refine best practices, policies, and procedures for information management, compliance/security, backup recovery/disaster recovery, change/release management, and infrastructure monitoring/support of database and reporting systems
• Participate long-range planning and budgeting, and ensures the achievement of organizational and operational plans
• Leads or participates in RFP development, acquisitions, evaluations and contract negotiations. Plans and coordinates software acquisitions, conversions and implementations. Responsible for vendor relations
• Ensure that priorities are established and evaluated on an ongoing basis for systems modifications and requests from our user community. Maintain effective organization and staffing to meet demand
• In coordination with other departments, ensure thorough evaluation of equipment/hardware capabilities and recommend hardware and platform acquisitions. Evaluate and recommend hardware environment architectures to support ongoing customer needs
• Identify efficient tools for business and clinical application design and development. Incorporate technology tools where appropriate
• Direct reports. Responsible for personnel actions, staff development, and training within the Information Technology department
• Oversight of all aspects of enterprise reporting, web services, change/release management, and web analytics.
• Ensure the accuracy of work estimates, improving the overall quality of deliverables/systems, and ensuring data models, database code, and enterprise reporting components developed by staff conform with identified best practices (i.e.: scalability, security, usability, etc.).
• Effectively implement, promote and ensure compliance with professional and industry standards, UMASS policies and procedures, and IS quality standards for database administration, application development, business analysis requirement definition, technology development, software testing, reporting, project planning/management, and administration infrastructure and support capabilities
• Perform other duties as required

REQUIRED QUALIFICATIONS:

• BS in Computer Science, a related degree, or equivalent experience
• 10 years of experience of Database and Business intelligence expertise in the development, procurement, implementation, and support of a networked, multi-vendor environment
• 5 years of experience with clinical data warehousing for research use with progressive management/supervisory responsibility as well as a strong demonstration of management experience (managing multiple projects/technologies/deliverables and at least 12 staff members)
• Extensive knowledge of data management infrastructures in a scientific research environment
• Strong strategic and operational planning skills, including management of full lifecycle implementations for major application implementation in both functional and matrix environments
• Excellent ability to communicate ideas and both verbally and written
• Demonstrated ability to analyze a wide variety of data and derive actionable insights.
• Demonstrated ability to set priorities, align stakeholder expectations, and develop and execute an associated plan of action

PREFERRED QUALIFICATIONS:

• Ph.D. or M.D. is ideal

Apply Here

PI92202252

This position provides support to  the RA aspects of the Consent Decree remediation activities at the Allston Landing facility, providing feedback to teams focused on Consent Decree and Workplan related activities and submissions.  This position also supports the RA aspects of dossier compliance project, tracking RA commitments related to the project.  In addition, this position supports general project management activities across the GRA CMC Biologics group.

Additional duties include:

Support coordination with our global manufacturing sites and integration of regulatory strategy with those sites;

Provide RA-CMC support to project teams as needed, working closely with cross functional teams to compile the required information in accordance with established timelines;

Coordinate and prepare regulatory document packages for submissions related to the Consent Decree Workplan activities;

Interact with RA colleagues world-wide and participate in the development of global regulatory strategies and RA-CMC program/process improvements;

Manage compilation of monthly product and project updates; coordinate internal group activities and meetings.

May supervise and coach regulatory professionals and be responsible for their development;

Provide support to the Director, Regulatory Affairs CMC Consent Decree and Compliance;

Support other RA CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.

Major Activities/Key Responsibilities

• Consent Decree
  • Actively monitor progress on numbered steps against milestone dates and inform senior management
  • Identify potential issues, propose remediation
  • Support compilation and submission of workplan amendments
  • Coordinate Notifications and meetings with FDA NEDO related to CD
  • Prepare and submit the periodic update document to the appropriate HA
  • Member of Consent Decree Steering Committee
  • Member of Consent Decree Governance Committee
• DCP program Support
  • Manage DCP schedule and timelines
  • Schedule and facilitate product kick-off meetings and steering committee meetings
  • Conduct Comparative Analysis Reviews per protocols
  • Develop Corrective Action Plans (CAP) where needed
  • Contribute to authoring of Interim and Final Report for each product
• Project Management
  • Coordinate monthly product / project updates
  • Serve as liason for contract activities for external staffing
  • Manage internal group activities and meetings

Basic Qualifications

• University degree in a scientific discipline with approximately 5-8 years regulatory experience.
• Biologics RA CMC Experience required.
• Knowledge of USA FDA regulations is essential.

Preferred Skills:

• Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
• Excellent organizational and communication (written and verbal) skills.
• Demonstrated ability to work successfully on project teams.
• RAC certification preferred.
• Previous experience working in a fast paced environment on multiple product lines
• Manufacturing, QA/QC experience #LI-SA

Job Responsibilities/Department Description: We are seeking a highly motivated individual to join a team of talented analytical scientists in Waltham, Massachusetts to provide analytical support to various drug discovery and development programs at Sanofi.  The position offers exciting opportunity for a scientist to interact with other scientists with a wide range of expertise, to learn new technologies, and to contribute.   In this role, you will be expected to design and plan experiments for LC/MS method development in consultation with your supervisor. You will routinely perform sample preparation and LC/MS analysis of lipids or other metabolites.  From time to time, you will serve as the liaison between project teams and the analytical group.  From time to time, you will also be responsible for assessing the performance of new instrumentations and their adoption to our laboratory.

Basic Qualifications: Ph.D. in Chemistry/Biological Sciences with 0-2 years of post-doctoral working experience or equivalent.  Extensive hands-on experience required in using LC/MS to solve analytical problems.  

Preferred Qualifications: Prior working experience with lipid characterization and quantitation is preferred. Familiarity with mass spectrometers from the major vendors and their data processing software is desirable.  As you will be expected to work in a multidisciplinary environment, excellent oral and written communication skills are also expected.

#LI-GZ