Summary

Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology  

Responsibilities and Tasks

Record GMP data, monitors and evaluates QC systems and equipment. Implement improvements to procedures, and revises SOP’s and GMP documentation as required. Interact with internal and external auditors including government agencies and contract manufacturing representatives. Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products. Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance. Perform and review growth promotion testing data for qualification of microbial culture media.  Perform microbial identification related to product and environmental testing. Perform sampling of raw materials as required for QC testing. Perform routine quality control testing as required and monitors or evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment) Maintain records in paper based or computer based systems Author and execute method validation/suitability protocols related to product testing. Author summary reports for executed method validation/suitability protocols. Author deviation reports and microbiological assessment reports related to departmental activities and product testing. Review Microbiology testing data as required. Coordinate receipt of raw material, in-process and final product samples for testing. Maintain metrics for receipt and processing of samples for microbiology testing. Provide technical input on product testing issues and instrumentation/equipment. Serve as liaison to service, calibration and technical representatives. Conduct and document assay failure and complaint investigations.

Knowledge Skills and Abilities

Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product Excellent verbal, written and interpersonal communication skills Proficient at following specific instruction (i.e. written SOPs) Working knowledge of cGMP/GLP Good computer skills including word processing and working with spreadsheets

Education and Experience

BS in related scientific field  required 2-4 years related experience

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

The position is part of the Global Manufacturing Science & Technology organization and is based at the biologics hub in Boston. The successful candidate will work as part of a group responsible for establishing a thorough process understanding, identifying and implementing process improvements and establishing next generation process development opportunities for upstream/downstream manufacturing of antibodies and antibody-like molecules expressed from mammalian systems. The position reports to the Lab Head, Upstream or Downstream Development. The newly established lab will cover the upstream aspects of the drug substance manufacturing process and focus on improving the understanding, robustness and economics of commercial manufacturing processes. The successful candidate will be part of the Process Sciences team.

POSITION OVERVIEW/KEY RESPONSIBILTIES:
• Demonstrates solid understanding and use of scientific principles and professional practices to solve a range of complex problems in creative and practical ways.
• Reviews existing process and analytical development and production data; designs and conducts necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments.
• Leads a small project team and provides scientific support and guidance in the development, scale-up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies and products.
• May contribute to technology transfer efforts of small project team between groups/organizations
• Maintains and demonstrates knowledge of state-of-the art principles and theories in area of responsibility
• May provide technical guidance to less experienced staff
• Collaborate with other scientists/engineers across the biologics network of sites
• Responsible for internal documentation and preparation of reports required for regulatory documents
• Support regulatory filings and interaction with authorities as subject matter experts
• Present data and results within department and project teams

LEADERSHIP QUALIFICATIONS:
• Strives for results – sets ambitious tangible results for the team, takes personal responsibility for achieving goals
• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization
• Makes decisions – Makes decisions when needed even if outcomes are difficult, accepts accountability for results and makes choices using sound judgment
• Leads Teams – Sets clear priorities for the organization and empowers the team to meet challenges and take action. Encourages collaboration with and beyond the team.
• Act for Change – Drives a continuous improvement mindset & develops high levels of employee engagement
• Develop people -takes responsibility for developing people. Learns from experience and helps other to do likewise.
• Provides feedback on a regular basis

BASIC QUALIFICATIONS:
• BS or MS in science/engineering with 5+ experience

PREFERRED QUALIFICATIONS:
• Experience with working in a team environment with other technical staff
• Excellent scientific background and presentations skills
• Strong understanding of development and commercial manufacturing operations
• Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams
• Knowledge of process development as applied to mammalian-expressed proteins

DISCLAIMER:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

#LI-GZ

The position is part of the Global Manufacturing Science & Technology organization and is based at the biologics hub in Boston. The successful candidate will work as part of a group responsible for establishing a thorough process understanding, identifying and implementing process improvements and establishing next generation process development opportunities for upstream/downstream manufacturing of antibodies and antibody-like molecules expressed from mammalian systems. The position reports to the Lab Head, Upstream or Downstream Development. The newly established lab will cover the upstream aspects of the drug substance manufacturing process and focus on improving the understanding, robustness and economics of commercial manufacturing processes. The successful candidate will be part of the Process Sciences team.

POSITION OVERVIEW/KEY RESPONSIBILTIES:
• Demonstrates solid understanding and use of scientific principles and professional practices to solve a range of complex problems in creative and practical ways.
• Reviews existing process and analytical development and production data; designs and conducts necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments.
• Leads a small project team and provides scientific support and guidance in the development, scale-up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies and products.
• May contribute to technology transfer efforts of small project team between groups/organizations
• Maintains and demonstrates knowledge of state-of-the art principles and theories in area of responsibility
• May provide technical guidance to less experienced staff
• Collaborate with other scientists/engineers across the biologics network of sites
• Responsible for internal documentation and preparation of reports required for regulatory documents
• Support regulatory filings and interaction with authorities as subject matter experts
• Present data and results within department and project teams

LEADERSHIP QUALIFICATIONS:
• Strives for results – sets ambitious tangible results for the team, takes personal responsibility for achieving goals
• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization
• Makes decisions – Makes decisions when needed even if outcomes are difficult, accepts accountability for results and makes choices using sound judgment
• Leads Teams – Sets clear priorities for the organization and empowers the team to meet challenges and take action. Encourages collaboration with and beyond the team.
• Act for Change – Drives a continuous improvement mindset & develops high levels of employee engagement
• Develop people -takes responsibility for developing people. Learns from experience and helps other to do likewise.
• Provides feedback on a regular basis

BASIC QUALIFICATIONS:
• BS or MS in science/engineering with 5+ experience

PREFERRED QUALIFICATIONS:
• Experience with working in a team environment with other technical staff
• Excellent scientific background and presentations skills
• Strong understanding of development and commercial manufacturing operations
• Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams
• Knowledge of process development as applied to mammalian-expressed proteins

DISCLAIMER:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
#LI-GZ

We are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, AKB-6548, to be a best in class HIF-PH inhibitor for the safe treatment of anemia secondary to CKD.

Akebia is currently expanding its Regulatory team to support multiple clinical assets and is searching for an Associate Director, Regulatory Affairs CMC. This individual will be responsible for CMC aspects, including drug substance, drug product, packaging/distribution within the Regulatory Affairs function, representing Regulatory Affairs on CMC teams and managing high-quality CMC submissions to regulatory agencies.  This position reports to the Vice President, Regulatory Affairs.

Required Skills

• Lead the preparation of high-quality CMC sections for regulatory submissions including INDs, IMPDs, annual reports, NDAs, MAAs, and briefing packages.
• Write CMC regulatory documents to support regulatory submissions using industry best practices and internal Akebia standards.
• Propose and design well-informed global CMC regulatory strategies )US, EU, and Japan).
• Represent Regulatory Affairs on CMC teams.
• Provide regulatory guidance to the CMC department (e.g., stability protocols, specifications, report reviews, C of A’s, product labels, and CMC development plans).
• Collaborate with internal CMC staff, consultants, and QA colleagues, as well as external Contract Manufacturing Organizations (CMOs) to document and resolve technical manufacturing issues under compliance with cGMPs.
• Assist in the preparation for regulatory agency meetings on CMC topics.
• Maintain knowledge of global CMC regulatory requirements and advise internal stakeholders on emerging CMC regulatory trends.
• Coordinate on-time delivery of high-quality regulatory submissions to regulatory agencies.
• Establish relevant processes and procedures to support Regulatory Affairs function activities.
• Participate in regulatory intelligence gathering activities and maintain knowledge of global CMC regulatory requirements.
• Ensure compliance with all regulatory requirements.

Required Experience:

• Bachelor's degree in chemistry, biochemistry, or pharmacy required; advanced degree preferred.
• Minimum of 8 years pharmaceutical industry experience with a minimum of 5 years in CMC Regulatory Affairs.
• Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages).
• Demonstrated evidence of writing of CMC regulatory documents.
• Knowledge of FDA and ICH CMC regulations and guidelines a must, knowledge of EU and/or Japan CMC regulations desirable.
• Knowledge of drug development.
• Excellent written and oral communication skills.
• Excellent interpersonal skills.
• Strong project management skills and drive for excellence.

Company Overview: BioAnalytix is a pharmaceutically oriented spin-out from the Barnett Institute of Chemical and Biological Analysis at Northeastern University in Boston, MA. Founded in 2012 by thought leaders in biologic drug development, regulatory strategy, and advanced analytics, BioAnalytix works with leading pharmaceutical companies to develop and apply advanced analytic technologies, methods and data in enabling, improving and accelerating biologic therapeutics from development through market.

Candidate Role: In this highly visible role we are looking for a candidate with direct experience and expertise in designing and managing advanced analytical characterization projects in biologic drug development. Primary responsibilities include analytic program design integrated with later-stage regulatory strategy, and related project management to timelines, milestones and deliverables to plan. Further required is the ability to identify, communicate and implement advanced LC-MS based analytic technologies, approaches and related method validation strategies that can be applied into later-stage biologic development and regulatory packages. The candidate will also be able to build highly successful relationships with scientific and senior-level team members both within BioAnalytix and with leading pharmaceutical partners and customers. The candidate should have a strong technical background in biopharmaceutical development plus advanced LC-MS based analytical systems and characterization methods, as well as strong skills and proven experience in data analysis, report writing, and project presentation. Regulatory knowledge, SOP and LIMS driven workflows and experience in GMP-level biologic development within a pharmaceutical company is a plus.

Key Responsibilities:

• Design, manage and deliver advanced analytic programs in late-stage biologic drug development and regulatory filings with leading pharmaceutical customers worldwide
• Manage internal research and partnered projects to plan; identify key areas of opportunity and risk; communicate, plan and implement solutions that enable thought-leading results
• Prepare, review and present project progress, results, analysis and strategic recommendations both internally and externally
• Design, develop and implement advanced analytic workflows and related SOP’s
• Serve as project lead with pharmaceutical partners and customers in both a scientific and a business management capacity

Qualifications:

• PhD in analytical or protein chemistry, with a minimum 5+ years of analytic experience in biologic drug characterization in a leading pharmaceutical company or regulatory organization
• Proven ability to deliver projects to objectives and timelines while managing internal and external teams, partnered programs and relationships at the highest levels of excellence
• Highly detail-oriented, self-motivated and results driven
• Excellent interpersonal, presentation, communication and writing skills
• Knowledge of later-stage regulatory processes particularly including IND and BLA filings

How to apply: careers@bioanaytixinc.com

Company Overview: BioAnalytix is a pharmaceutically oriented spin-out from the Barnett Institute of Chemical and Biological Analysis at Northeastern University in Boston, MA. Founded in 2012 by thought leaders in biologic drug development, regulatory strategy, and advanced analytics, BioAnalytix works with leading pharmaceutical companies to develop and apply advanced analytic technologies, methods and data in enabling, improving and accelerating biologic therapeutics from development through market.

Candidate Role: In this highly visible role we are looking for a candidate with direct experience and expertise in designing, managing and delivering advanced analytical projects and CMC packages in biologic drug development. Primary responsibilities include analytic/biologic program design integrated with later-stage regulatory strategy, and related project management to timelines, milestones and deliverables to plan. Further required is the ability to identify, communicate and implement advanced analytic approaches and related method validation strategies that can be applied into later-stage biologic development and regulatory packages. The candidate will also be able to build highly successful relationships with senior-level team members both within BioAnalytix and with leading pharmaceutical partners and customers. The candidate should have a strong technical background in biopharmaceutical development, as well as strong skills and proven experience in data analysis, report writing, and project presentation. Direct regulatory experience in GMP-level biologic drug development within a pharmaceutical company is a plus.

Key Responsibilities:

• Design, manage and deliver advanced analytic programs in late-stage biologic drug development and regulatory filings with leading pharmaceutical customers and partners worldwide
• Manage partnered projects to plan; identify key areas of opportunity and risk; communicate, plan and implement solutions that enable highly successful results
• Present advanced analytical data and related regulatory strategies in key scientific, regulatory and biologic development program meetings
• Manage executive level relationships with strategic partners at the highest level of excellence
• Serve as project lead with pharmaceutical partners and customers in both a scientific and a business management capacity

Qualifications:

• PhD in analytic or biochemistry with a minimum 5+ years of protein analytic, protein process sciences and/or regulatory experience in biologic drug development in a leading pharmaceutical company or regulatory organization
• Proven ability to deliver projects to objectives and timelines while managing internal and external teams, partnered programs and relationships at the highest levels of excellence
• Highly detail-oriented, self-motivated and results driven
• Excellent interpersonal, presentation, communication and writing skills
• Knowledge of later-stage regulatory processes particularly including IND and BLA filings

How to apply:careers@bioanalytixinc.com 

We are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with kidney disease. We are developing our lead product candidate, AKB-6548, to be a best in class HIF-PH inhibitor for the safe treatment of anemia secondary to CKD. AKB-6548 has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b. Following its IPO in March 2014, the company is preparing for expansion to support global phase 3 programs.

Akebia Therapeutics is looking for an experienced GCP Auditor. The position will be responsible to assess compliance with Akebia standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. Responsibilities include performing audits; internal systems, supplier, and of clinical trial sites. Audit findings are required to be summarized in a written report format according to Akebia SOPs and monitored for appropriate resolution. Audit findings are presented in an objective professional format, to the auditee. This role participates in the development, implementation and maintenance of the corporate GCP Quality Management System and training program. This is a cross functional position that works with Akebia personnel in other departments, particularly Clinical Operations, in a collaborative nature as an internal consultant on regulatory topics and interpretations. Strong communication skills (written and verbal), with the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, clinical laboratories and other clinical suppliers.

Required Skills:

• Understand the drug development process
• Assure Corporate compliance with SOPs and GCP regulations
• Have the ability to lead and coordinate diverse audit teams
• Perform internal system, supplier, and clinical trial site audits
• Accountable for accuracy of audit findings
• Conduct follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution
• Read, understand, interpret, and apply regulations, guidance documents, study protocols, and clinical trial materials
• Participate in solving GCP compliance issues within  Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs , Pharmacovigilance
• Coordinate joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
• Maintain a working knowledge in the specific areas related to GCP compliance including, but not limited to regulatory US FDA regulations/guidance documents and ICH guidelines
• Maintaining all associated department spreadsheets, tracking of audit findings, and audit files as applicable
• Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
• Assist in pre-qualification, and routine compliance audits of clinical suppliers (phase 1 units, IRBs, translators, depots, etc.)
• Assist in development and implementation of pre-approval inspection readiness plans at investigative sites.
• Assists senior staff during regulatory inspections
• Serve as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices within Akebia
• Prepares required documentation to support audit activities including; audit plans, audit    reports, audit certificates and corrective action plans
• Represents QA department at investigator meetings and CRO training programs/kick off meetings

Required Experience:

• Bachelor's degree in science or equivalent, with 5+ years of experience in conducting GCP Audits (QA experience in the Pharmaceutical industry required) Excellent knowledge of GCP regulations
• A strong understanding of GCP regulations and an ability to apply them to clinical research and/or related processes is required
• Inspection experience in hosting or supporting regulatory authority inspections (US FDA, Health Canada, EMA, MHRA)
• Experience in auditing for compliance of computer system validation (CSV), pharmacovigilance systems, Good Clinical Practice, Central Laboratories and nonclinical GLP is highly desirable
• Excellent technical writing skills
• Strong Communication skills (written and verbal), interpersonal and problem solving skills and detail oriented
• Domestic, international overnight travel is required

The Clinical Supply Manager plans, establishes and monitors the global clinical supplies strategy for protocol development at the study level, to ensure appropriate processes are established and in order to achieve the clinical supplies key deliverables for each study within each program. The CSM is accountable for driving the drug supply material planning, at the study level, for global clinical studies using investigational product, commercial and comparator material in collaboration with the global clinical teams. The Clinical Supply Manager monitors inventory levels of clinical supplies as well as key intermediates and manages the processes to maintain targeted inventory at clinical sites. The manager will assist in development of supply chain strategies for global clinical trials including investigational products, placebos and comparators

Required Skills:

• Responsible for implementation of clinical supply plans, based on clinical study protocol and clinical development plans
• Collaborate with Clinical Trial Managers, clinical packaging sites, applicable internal functional areas, CROs, and others as applicable to evaluate and maintain up-to-date status records and reporting for all clinical supply-related activities across projects / products
• Develop, manage, and utilize appropriate inventory reporting tool(s) for maintaining clinical supply inventory and forecast records
• Develop and maintain information and reporting, in collaboration with QA, to ensure transparency of project / product current expiry periods
• Collaborate with Clinical Operations, packaging CROs, QA and regulatory agencies to develop regulatory compliant labels for finished product
• Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material
• Ensures uninterrupted supplies throughout the duration of a clinical study program. Maintains/tracks inventory of available clinical supplies and tracks expiration dates. Coordinates with CMC and QA partners to manage technical and quality issues to facilitate uninterrupted supplies
• Collaborate with Clinical Trial Managers to develop the drug distribution strategy for each trial and lead the development
• Review IWR specifications and perform acceptance testing of IWRS when applicable
• Work with IVRS systems and monitor the site and depot inventory levels and settings; provide oversight to site and depot shipments; place manual orders as needed
• Monitor and report on clinical supply inventory for each project / product
• Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planning
• Collaborate with Clinical Trial Managers and Project Leads to both gather project / product clinical trial forecast requirements and demand history data, and generate / revise clinical trial inventory forecast requirements for planning purposesWorks with external consultants and third party vendors to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements
• Ensures that key project milestones are met; negotiates and communicates supply plan timelines to internal and external partnersOther duties and activities as defined by management to enhance management of clinical trial inventory, chemistry, manufacturing and controls logistics
• Lead cross functional team meetings to ensure clinical supply needs are being communicated and met
• Develop Clinical Supply related SOPs

Required Experience:

• Bachelor’s Degree – preferred in health sciences, Biology, Chemistry, Nursing, or Pharmacy
• 5+ years of supply chain experience
• General knowledge/understanding of global R&D processes
• Strong organizational and forecasting skills
• Ability to strategically plan, organize and manage multiple projects simultaneously
• Ability to maintain accurate records and files in accordance with GxPs and SOPs
• Demonstrated track record of creativity and problem solving within a regulated environment
• Ability to exercise independent judgment with minimal supervision
• Demonstrated ability to work effectively in a global/matrix environment

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings or vendor sites, including overnight trips. Some international travel may be required

Head the Quality function at Akebia. Responsible for the development, implementation, and administration of the Quality Management System (QMS) including activities, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. Activities include management and GMP oversight of product development, testing, stability, validation data, documentation, and records relating to the manufacturing, sampling, testing, analysis, and investigation of clinical and commercial drug materials manufactured by or for the company.  Also manages and oversees clinical and nonclinical quality aspects of Akebia’s programs (e.g., GCP, GLP). Reports to the Vice President of Regulatory Affairs.

Required Skills:

• Manage the Quality Organization.
• Develop, implement, and administer the Quality Management System (QA Manual and other Controlled Documents, including Standard Operating Procedures, Forms, Templates, Policies, etc.).
•  Develop, direct, and/or oversee QA activities and programs for internal and third party supplier operations that are subject to GXP regulations and guidelines; establish QA Agreements, as needed.
• Provide direct QA-GMP oversight of drug substance and drug product contract manufacturers and contract test labs.  Perform GMP audits. Responsible for disposition of clinical materials used in human clinical trials.
• Provide expert technical analysis and evaluation of QA issues affecting corporate projects, establish risk mitigation and best practice strategy for resolution.
• Direct all Corrective Action/Preventative Action (CAPA) investigations (CMC, clinical, nonclinical), investigate suspicions of Fraud and or Misconduct, and Serious Breach Reporting where required.
• Facilitate audit requests including due diligence visits.
• Lead inspections by Regulatory Authorities. Support preparation of clinical trial sites, contract manufacturers, and nonclinical testing laboratories for audits (e.g., Pre-Approval Inspections) by Regulatory Authorities.
• Consult with and provide regulatory training (GMP, GCP, GLP) to company departments on a regular basis.
• Participate on project teams and/or working groups, as required.
• Develop, manage, and ensure effective implementation of corporate audit plan.

Required Experience:

•  Bachelor’s degree in a scientific discipline such as chemistry, biology, microbiology or similar required.  Advanced or doctorate degree in a scientific discipline preferred.
• Minimum of 3 years in Director of Quality Assurance or higher position within the pharmaceutical/biotech industries.
• Minimum of 8 years of experience in a FDA-regulated pharmaceutical environment performing QA functions, with a minimum of 1-3 years in a supervisory QMS management capacity, in a GXP pharmaceutical environment.
• Comprehensive knowledge of quality principles and cGMPs required. Knowledge of GCP and/or GLP requirements preferred.
• Experience leading Regulatory Authority Inspections required.
• Strong interpersonal skills; the ability to interact effectively with all levels within the organization, third parties, and regulatory authorities.
• Excellent project management and decision-making skills.
• Experience in commercial drug product release and commercial launches preferred.

Reporting to the Head of Clinical Research, the Clinical Research Scientist (CRS) will support the clinical conduct of clinical studies.  The successful candidate will contribute to the day-to-day scientific and clinical support for ongoing clinical studies.  This function works in collaboration with a Director of Clinical Research that is responsible for the clinical study oversight.  This function is accountable for working closely with the clinical and operational teams to deliver enhanced efficiencies and quality around clinical deliverables.  The CRS will perform functions that require some degree of clinical judgment; however, the Director of Clinical Research will retain ultimate accountability for the clinical services.

Required Skills:

• Support the Clinical Research team to ensure the effective startup, conduct, and close-out of clinical studies
• Work closely with Clinical Study Manager, study monitors, and others in the day-to-day management of clinical studies
• Support cross-functional study team meetings in collaboration with the Director of Clinical Research
• Represent Clinical Research in study sub-teams
• Assists in identification of data discrepancies and works with Clinical Operations to correct inconsistencies within the clinical study database to ensure integrity of accruing study data
• Review study data and prepare summary reports and data profiles to monitor ongoing studies and assist in identifying trends
• Support the Clinical Research team in all activities related to review efficacy data from clinical studies
• Work with Director of Clinical Research in preparation for Data Monitoring Committee (DMC) meetings
• Contribute to the development of protocols, consent forms, case report forms, and other routine study documents
• Assists in review of final study results and contributes to the Clinical Study Report
• Assists in monitoring adherence to protocols
• May interact with investigational sites, Contract Research Organizations (CROs), and other vendors to assist in answering scientific and clinical questions
• Work with Clinical and Medical Directors in preparation of abstracts, posters, presentations, and manuscripts
• Support clinical team in conducting pertinent literature reviews
• While performing functions that require some degree of clinical judgment, the CRS will work closely with the study Clinical Director who will retain ultimate accountability for clinical decisions

Required Experience:

• Bachelor’s degree with a clinically relevant degree in Life Sciences / Nursing / healthcare
• Minimum 5 years’ experience in clinical research in the pharmaceutical/biotechnology industry
• Strong analytical and problem solving skills with exceptional organization and attention to detail
• Independently motivated
• Strong interpersonal, communication, and presentation skills
• Excellent writing skills
• Strong computer skills including Microsoft Word, PowerPoint, and Excel
• Ability to work on teams and with multiple projects, and to work well under general direction with tight timelines
• Knowledge of GCP and ICH Guidelines
• May require travel up to 10%, domestically and internationally
• CRA experience is a plus
• Experience in one or more of anemia, chronic kidney disease, dialysis, and/or oncology is a plus

The Medical Research department is responsible for the medical aspects of all clinical trials. The team leads the organization in setting the strategy to enable the preparation of clear and concise clinical development plans (CDP) and statistical analysis plans (SAP) for all Akebia programs. This medical function will provide therapeutic area as well as general medical expertise, from high-level protocol development through study conduct, global regulatory submission(s) and product launch. This individual will be an integral member and leader of the clinical organization. This person will play a key role in helping to advance novel technology and compounds into clinical trials, with a particular focus on clinical and translational programs.  

The incumbent will be responsible for strategic development and implementation of the company’s clinical programs including the following: design and implementation of clinical trials, selection of indications, clinical sites, and investigators. The person will design clinical protocols, participate in clinical timeline development and other study related documents as needed as well as provide medical oversight for the program. Further, the incumbent will ensure compliance with all applicable regulatory guidelines.

Required Skills:

• The initial focus of this position is to advance the clinical development of AKB-6548 through large cardiovascular outcomes trials leading to global regulatory submissions
• Present scientific, medical and regulatory meetings globally
• Develops and maintains relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
• Work closely with Commercial and Medical Affairs to design and implement clinical development plans and Phase 1-4 studies to address scientific and medically important questions
• Contributes to activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents.
• Partner with pharmacovigilance to assess the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
• Perform ongoing medical review of clinical trials including participation in safety monitoring team reviews
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
• Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.

Required Experience:

• MD required with nephrology, or cardiology training preferred; experience with cardiovascular outcomes trials and/or renal anemia trials desirable. 5 years of industry experience preferred.
• Experience with the design and execution of CDPs, Phase 1-3 clinical studies including preparation of protocols, Investigator Brochures and other relevant study document, SMPs and SAPs.
• Prior experience with the design and execution of large Phase 3 studies or cardiovascular outcomes (CVOT) trials preferred
• Global regulatory agency experience at the country and regional level (e.g. country level, EMA, FDA), including submission of briefing documents and/or region specific MAA’s
• Excellent working knowledge of FDA & ICH/GCP regulations and guidelines
• Experienced in presenting at investigator meetings, advisory boards and medical and scientific conferences
• Experience conducting and managing complex clinical trials through contract research organizations (CROs) and other vendors.
• Excellent communication and presentation skills are essential.

POSITION:          Senior Manager, Clinical Business Operations

LOCATION:         Cambridge, MA - moving to Waltham, MA December 2015

REPORTS TO:     VP Clinical Operations

POSITION SUMMARY

Reporting directly to the VP of Clinical Operations, as well as matrix responsibilities to Finance and Legal, this position will have primary responsibilities for business operations within the Clinical Operations function. Responsibilities include but are not limited to: leadership and management of financial planning and monthly expense reporting; clinical/pharmacovigilance vendor outsourcing services planning and oversight; clinical/regulatory consultant services planning and oversight; and internal clinical resource planning and recruitment.  

This role serves as the primary business contact to clinical/pharmacovigilance vendors, managing the strategic business relationships required to meet corporate goals and strengthening relationships with current and prospective vendors needed for future programs.  

Incumbent will be required to effectively collaborate with vendors and with cross functional groups within Ceruelan, including Clinical, Regulatory, Quality, Legal and Finance.  

KEY RESPONSIBILITIES

Financial Planning and Reporting

• Establish and lead the process for Clinical financial activities including budget planning, projected spend planning and monthly accrual reporting with Finance.
• Responsible for budget preparation in anticipation of outsourcing and internal resource needs in collaboration with  the Clinical Operations, Regulatory, Program Management and Finance team
• Develop and report metrics for financial planning and expense reporting

Vendor Oversight

• Provide strategic direction, leadership and oversight for the sourcing of Clinical  vendor services
• Develop new global and regional / US-based outsourcing strategies to meet corporate goals as new projects are proposed in collaboration with Clinical Operations
• Establish and lead the RFP process for outsourced services, lead review of proposals with involvement from critical Cerulean cross functional groups
• Identify and communicate contractual needs to legal and finance for vendor master agreements
•  Establish and lead Clinical vendor Joint Oversight Committees (JOC) for outsourced clinical projects  
• Liaison with vendor management team and JOC to ensure that vendor service-related issues  are resolved quickly to prevent and/or limit impact to project timelines and deliverables
• Develop and report vendor metrics for oversight, evaluation and results reporting

Internal Resource Planning

• Strategic planning for internal resource needs in collaboration with VP Clinical Operations
• Lead the resource planning and recruitment process to ensure clinical programs are staffed appropriately to meet corporate goals
• Liaison with pharmacovigilance vendor to communicate anticipated projects for future timeline and budget planning
• Create Transfer of Regulatory Obligation (TORO) to ensure appropriate transfer of obligations are documented  for submission to regulatory agencies
• Planning and oversight of regulatory consultant services with direction from Regulatory Affairs

QUALIFICATIONS / EXPERIENCE

• Bachelor degree, Masters preferred in health sciences and/or life sciences and/or business management
• Minimum 7+ years of experience in clinical operational role including global programs with direct oversight of various international and domestic  vendors
• Experience leading cross functional teams including outsourced vendor participants
• Knowledge of clinical trial regulatory requirements in US; understanding of other international  regulatory requirements preferred
• Demonstrated success in project management and/or clinical trial planning and execution
• In-depth understanding of the drug development process, clinical trials conduct and execution, Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Solid understanding of financial management, including management of budget, accruals, and forecasting
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills
• Flexibility to thrive in a rapid paced dynamic environment

My biopharmaceutical client located in the heart of the biotech hub is looking to add an experienced and talented scientist to their team.  If you are skilled in cellular and molecular biology, your experience can have a considerable impact on leading the development of new class drugs.
Requirements:
•    PhD at the Scientist level, or experienced MS at the Scientist level
•    Experience in cancer discovery biology
•    Able to perform assays concerning apoptosis, cell-death, viability ELISA, Western, etc.
•    Experience and willingness to train others
About StratAcuity:
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

For more information, go to: http://www.cwsciences.com/Current-Openings/Production-Associates

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Senior-Clinical-Project-Manager

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Instrumentation-SpecialistField-Service-Engineer

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Sales-Administrator

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Sales-Representative-Instrumentation

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Sr-Research-Associate-Cell-Culture

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Pharmacovigilance-Manager

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com