Part-time consultant veterinarian will provide guidance on clinical care for transgenic rabbit colony used for the production of biopharmaceuticals at our facility in Charlton, MA.

Position will require site visit at least monthly with regular consultation via telephone additionally as needed. Seeking a veterinarian with experience with SPF rabbits and barrier facility operations and familiarity with good manufacturing practices (GMP), standard operating procedures (SOP’s), rabbit husbandry, and nutrition. Contract labs are contracted and utilized for sentinel health monitoring and monthly results will need to be reviewed, interpreted, and acted upon. Candidate cannot own rabbits or rodents. Strict biosecurity control measures in place. DACLAM veterinarian preferred.

CLIENT: BIOTECH COMPANY

MD NEEDED

Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor. May represent Drug Safety and Risk Management at internal and external meetings. The MD can be appointed as the Global Safety Officer for a specific compound / product. 
The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management within company, external stakeholders in the medical community as well with global regulatory authorities. 

1. Manage safety surveillance for assigned compounds / products 
a. Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals. 
b. Conduct analysis of safety data. 
c. Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed products including decisions on seriousness, expectedness, and causality. 

2. Provide safety strategic leadership for clinical development programs / program teams 
a. Integrate the safety scientific component to build a strategic framework for clinical development plans. 

3. Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical. 

4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities. 

5. If applicable, manage Medical Director(s) and Associate Medical Director(s) overseeing their activities for assigned compounds / products. 

• Minimum 5 years experience in the pharmaceutical industry or clinical care setting. 
• Preferably has prior experience in clinical development or drug safety. 
• Knowledge of pre- and post- marketing US and EU regulations 
• Knowledge of clinical pharmacology highly desirable. 
• Demonstrated strategic and critical thinking. 
• Excellent communication skills (oral and written) and excellent organizational skills. 
• Capacity and willingness to work effectively across disease areas. 
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. 
• Demonstrated sense of urgency and accountability for both individual and team-owned work products. 
• Excellent communication skills (oral and written) and excellent organizational skills. 
• Capacity and willingness to work effectively across disease areas. 
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. 
• Demonstrated ability to work in an entrepreneurial culture 

MD, or MD PhD, or MD MPH required; sub specialty training highly desirable

CLIENT: BIOTECH COMPANY

MD NEEDED

COMPENSATION: $$$

This individual is responsible for safety and benefit-risk assessment for investigational products. The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds as they enter into human studies and progress to the development process. 

Accountabilities include: 
• Conduct safety surveillance for clinical programs. 
• Provide safety strategic leadership for clinical programs. 
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities and safety agreements with corporate partners. 
• Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Biostatistics, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences and other stakeholders. 
• Ensure development and implementation of department policies and strategies consistent with regulatory requirements and industry best practices. 

Interpersonal skills 
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic matrix environment. 
• Demonstrated strategic and critical thinking. 
• Excellent organizational skills and communication skills (oral and written). 
• Capacity and willingness to work effectively across multiple disease areas. 
• Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. 

Minimal Education and Experience Requirements: 
• Advanced degree (MD, or MD PhD, or MD MPH) of recognized and accredited medical school. 
• Minimum 3 years of experience in the pharmaceutical industry or clinical care setting. 
• Industry experience in early stage development is highly desirable. 
• Benefit-risk related strategy experience required. 
• Knowledge of clinical pharmacology and pre-clinical safety highly desirable.

The KEW Group is a personalized medicine company with a focus on oncology founded by leading scientists and business professionals. We use a multidisciplinary clinical approach to support decision-making in cancer care delivery. Our platform integrates patient-specific genetic data generated from next-generation sequencing with the most current knowledge of disease and therapeutics. Together these enable the delivery of optimal treatment strategies tailored to the patient. We anticipate that implementation of our strategies will result in significant improvements in cancer treatment. We are seeking motivated professionals to be a part of our new team.
The successful candidate for the molecular Diagnostics Scientist will be an integral member of the KEW Group team focused on developing and implementing advanced genetic and genomic technologies to support our strategy. The candidate will be responsible for implementing molecular biology techniques including generation of DNA sequencing data, and for assays optimization.

 PRINCIPAL DUTIES & RESPONSIBILITIES

The MDx Scientist will organize and perform Research and Development, as well as validation of clinical laboratory tests including but not limited to:

- Extract and quantify DNA/RNA from human tissue samples;

- Perform Bioanalyzer, Tapestation, NanoDrop and other techniques to analyze DNA and RNA products;

- Perform sequencing library preparation reactions in manual as well as high throughput fashions;

- Actively search for and learn new scientific approaches to benefit the company;

- Participate in lab meetings, generate ideas for improving efficiency and productivity in the lab’s operations;

- Create and update standard operating protocols for laboratory-based methods;

- Follow existing protocols and regulations to maintain equipment and reagents;

- Enter experiment information into a laboratory notebook and LIM system;

- Troubleshoot abnormal results with minimal oversight and feedback;

- Implement new infrastructure, including new technologies and platforms;

- Communicates basic lab needs to Lab Manager for both technical and administrative issues;

- Responsible for organizing and maintaining laboratory inventory.

 SKILLS & ABILITIES REQUIRED

- At least Bachelor’s degree in biology, biochemistry, biotechnology, genetics or related science field;

- Requires 5+ years of molecular biology laboratory experience, and that have some experience with next generation sequencing technologies. Strong computer skills. Preference given to individuals who have worked in a clinical laboratory setting;

- Ability to communicate effectively to colleagues and staff across multi-disciplinary areas, while contributing to a high-quality and respectful work environment;

- Ability to work in a multidisciplinary, fast-paced, dynamic and results-oriented startup environment required;

- Excellent attention to detail and dedication to excellence

Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry.

This position is responsible for managing all aspects of Merrimack’s computer related systems validation program for cGxP systems requiring validation/qualification. 

Job Responsibilities:

• Manage, coordinate, and/or perform the development of validation protocols, the execution of validation studies, data analysis, and compilation of the data and results into final reports.  Schedule and lead meetings with information technology, quality assurance, and system end user personnel to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol acceptance criteria.  Lead or coordinate, as applicable, investigations into failures to meet protocol acceptance criteria. Review and approve validation protocols and reports. (40%)
• Review proposed changes to validated computer systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change. (20%)
• Author and administer a corporate computer system validation policy and chair the associated computer system validation panel.  Develop and standardize appropriate procedures to be used in validating computer systems, manage and control validation documentation in collaboration with QA.  Ensure the validation policy is focused towards achievement of 21 CFR Part 11 compliance. (10%)
• Develop validation lifecycle master plans and execution plans for computer system validation projects; develop and manage the associated validation project budgets. (10%)
• Train internal or contract personnel who will be executing computer system validation protocols on how to execute the protocols. (5%)
• Review proposed new computer systems or software applications that require validation and provide Validation’s perspective on these systems. (5%)
• Work with other Validation Personnel to assure consistency in computer validation of testing, utility, process, and equipment/instrument control and data acquisition systems. (5%)
• Perform qualification audits of IT vendors and resources. (5%)
• Identifying current and anticipated requirements for compliant computerized operations and suggesting methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance with the appropriate federal and international regulations.
• Developing computer validation policies, procedures and protocols; investigating/troubleshooting validation problems for computer systems, automated equipment, and control systems. 
• Keeping abreast of evolving federal and international regulatory requirements, government audit policies, the availability of current techniques and literature regarding compliant computer operations, and serving as an information resource.

Requirements:

• B.S. with 7-12 years of validation experience or M.S. with 5-10 years of validation experience.
• Experience in validating computer systems in the biopharmaceutical or pharmaceutical industries.
• Demonstrated experience in successfully managing complex validation projects is required.
• Preference given to candidates with previous and successful validation of Laboratory Information Management (LIMS) systems, system control and data acquisition systems, electronic Quality Management Systems (eQMS), Enterprise Resource Planning systems (ERP), and in implementing 21CFR Part 11 requirements.
• This position requires excellent leadership, organizational and communication skills, and a thorough knowledge and understanding of FDA and international validation requirements and expectations.  The incumbent must be self-motivated, able to correctly set his/her own priorities for the multiple projects that will be simultaneously managed, and meet project deadlines and budgets.
• The incumbent will be involved in a wide range of complex, cross-functional area problems, which require the regular use of ingenuity and creativity, working without appreciable direction, and exercising considerable latitude in determining assignment objectives.   She/he may determine the methods and procedures used on new assignments.  Completed work is reviewed from a relatively long term perspective for desired results.
• Travel to other locations and to vendors for audits will be occasionally required. 
• While this position may not have direct reports, it is expected to provide guidance or oversight to company personnel and contractors.
• This position will have frequent contact with senior management and outside senior professionals and act as the prime validation contact for the project group.
• The position will also be the point person for the CRS validation program to inspectors during regulatory inspections/audits.

The Company:

Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

The Role:

The Clinical Project Coordinator (CPC) will be responsible for providing administrative and operational support for all aspects of a clinical study in accordance with applicable policies and procedures. Track and communicate overall study status by generating meeting agendas, minutes, trackers, and status reports; and distributing to internal and external parties, as appropriate.

Responsibilities:

• Provide general assistance and administrative support to the Clinical Project Teams
• Ensure trial master files are current and maintained
• Process vendor and site payments. Track payments against contract and budget projections with input from the CPM or senior level staff.
• Coordinate site and vendor contracts from review through execution
• Maintain contact with investigative sites for specific requests, for example, obtaining regulatory documents (1572’s, CV, etc.)
• Assist with tracking and qualify investigators (e.g. investigator database, feasibility)
• Review site essential documents for completeness (under the direction of the CPM or senior level staff)
• Coordinate document translation, if required
• Assemble study manuals, binders, presentations and tools, under the direction of the CPM or senior level staff.
• Attend project team meetings and generate meeting minutes

Requirements: 

• Knowledge of the clinical research process
• Excellent written and verbal communication skills
• Excellent  organizational and time management skills
• Demonstrated ability to form strong functional relationships, maintain a positive attitude, and ability to interact with all levels of staff to coordinate and execute study activities
• Proven ability to work independently and prioritize work
• Experience juggling multiple priorities within multiple clinical trials
• Microsoft Office skills

Experience Required:

• Minimum of one (1) year of related experience in a clinical trial setting is required

Education:

• BA/BS degree preferred

To apply for this position, please send your resume as an attachment to:

work@flexiontherapeutics.com

The Company:

Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

The Role: 

Reporting to the Vice President, Clinical Operations, the Associate Director, Clinical Operations (ADCO) is responsible for successfully leading and managing the execution of assigned clinical studies from protocol inception through study closure following Good Clinical Practice (GCP) and the Code of Federal Regulations.  The ADCO is responsible for overseeing day-to-day study operations to meet individual clinical trial objectives.  The ADCO will develop/expand therapeutic area expertise, foster relationships with investigators, collaborators, and vendors and will contribute to the development and continuous improvement of Clinical Operations processes. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Responsibilities:

• Oversees assigned studies and accountable for results for all components of study
• Manages selection of contract research organizations (CROs) and vendors:  initiates requests for, reviews, and provides input to new vendor proposals/contract development
• Manages and tracks project conduct across all functions (e.g., site management, safety, data management, labs, etc), generates study specific plans and documents, creates trial-related training materials as needed
• Provides oversight and support for study team, leads team meetings
• Facilitates the development of study related documents (contracts, ICFs, protocols, IBs, etc.)
• Facilitates review of CRFs, CRF guidelines, Data Management Plans , edit check specifications, Statistical Analysis Plans
• Establishes and maintains study timelines: study startup activities, patient accrual timelines, data cleaning activities and support
• Creates /reviews study status reports
• Proactively identify and address possible opportunities and issues
• Collaborate with colleagues, outside consultants, and vendors to ensure successful completion of assigned clinical trials
• Provides oversight to Trial Master File
• Assumes other project responsibilities as needed
• Ensures compliance with SOPs, GCP and regulatory requirements for assigned clinical trials
• Participates in the development and continuous improvement of SOPs and Clinical Operations systems
• Travels as necessary (~10-20%) 

Requirements: 

• Requires a BA/BS, BSN, or related degree with at least 5+ years relevant clinical operations experience, with at least 3 years in clinical project management
• Technical expertise in and/or understanding of cross-function clinical trials processes from study start-up through study closure
• Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR
• Experience managing contracted organizations; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
• Effective project management skills with ability to anticipate problems relating to projects and to develop and implement solutions
• Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Proven success in meeting project timelines and budgets
• Ability to foster effective relationships with vendors, investigators, consultants and colleagues
• Ability to work independently as well as in a team environment
• Excellent communication, writing and presentation skills; must be highly computer effective
• Flexibility and the drive to meet project deadlines is required. 
• Data Management experience is a plus
• Osteoarthritis or pain clinical study experience is a plus
• Phase 3 and international experience is preferred

To apply for this position, please send your resume as an attachment to:

work@flexiontherapeutics.com

The Company:

Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

The Role: 

Reporting to the Vice President, Clinical Operations, the Clinical Trial Manager will oversee some or all elements of clinical studies with oversight. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.  The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables.

Responsibilities:

• Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
• Serve as the primary liaison between Flexion and assigned CROs in the execution of outsourced clinical trial functions
• Oversee study activities such as: selection of investigators, study start-up activities including site initiation, study monitoring activities and data collection
• Develop and manage study timelines for assigned operational elements

• Contribute to the development of study related documents (Monitoring Plans, contracts, ICFs, protocols, IBs, etc.)
• Participate in review of CRFs, CRF guidelines, Data Management Plans , edit check specifications, Statistical Analysis Plans
• Participate in the preparation and negotiation of clinical site and assigned CRO budgets and track variances
• Project and track study enrollment, deviations, data entry and drug supply
• Track and file all critical study documentation or manage trial master file maintenance at a CRO
• Provide routine updates to project team on study status/issues
• Approximately 10% travel, primarily involving travel to conferences, Investigator meetings, or co-monitoring

Requirements: 

• Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures
• Ability to work independently
• Working knowledge of GCP, ICH and relevant CFRs is required; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
• Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes
• Excellent communication, writing and presentation skills; must be highly computer effective
• Osteoarthritis or pain clinical study experience is a plus
• Phase 3 and international experience is preferred

Experience Required:

• 3-5 years clinical operations experience; prior experience as a CTM with direct management experience of vendors and CROs desirable

Education:

• Requires a BA/BS, RN, or related degree

To apply for this position, please send your resume as an attachment to: 

work@flexiontherapeutics.com

The Company:

Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

The Role: The CMC Project Manager will be a member of the core program team representing CMC and will partner with the Scientific Technical Lead and other senior leaders in the development and implementation of CMC project strategies and comprehensive project plans.

This role will report directly to the Sr. Vice President of Program Management with dotted line responsibilities to the VP of CMC Operations.

Responsibilities:

• Lead CMC teams in establishing clear scope of work and drive team towards the delivery of project milestones on time, on budget, and within scope through utilization of project management tools
• Lead CMC teams to:
  • Identify CMC project objectives
  • Build  fully integrated project schedules capturing all activities and resources needed to deliver the against corporate goals
  • Identify measurable success criteria
  • Monitor project progress and identify risks and opportunities to timeline, budget or scope
  • Ensure adequate plans are in place to mitigate risks and enable opportunities
  • Effectively communicate progress at all levels and escalate critical issues appropriately
  • Ensure project sub-teams apply the techniques stated above to their planning
• Assist CMC leadership with management of the CMC budget by monitoring actuals to plan and forecasting
• Support CMC planning for regulatory filings worldwide
• Facilitate and incorporate lessons learned, best practices, etc.
• Coordinate and lead internal and CMC-Vendor  meetings, and document and communicate key takeaways to relevant constituents

Requirements: 

• A minimum of 5 years of relevant Project Management experience
• A minimum of 2 years of experience within a CMC Function or group with hands on experience in late phase drug product development or 2 years of specific CMC project management experience with a complex manufacturing development processes     
• Proven project management skills
• Superior written and verbal communication skills
• Strong organizational skills and attention to detail
• Strong knowledge of team dynamics, structure, roles and responsibilities
• Excellent ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks
• Ability to respond quickly and effectively to changing environments
• Demonstrated ability to manage and lead others through change
• Demonstrated ability to influence outcomes and key project decisions without authority
• Ability to work both independently and in a team focused environment
• Skilled facilitator and negotiator with a keen eye for detail
• Some US and international travel required (less than 20%)

Education:

• Bachelor of Science degree in Chemistry, Chemical Engineering, Mechanical Engineering or related discipline

To apply for this position, please send your resume as an attachment to: 

work@flexiontherapeutics.com

Position Description:

In this important Clinical Operations leadership role, the Clinical Study Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. In addition to exceptional project delivery, we seek strong analytical skill and leadership qualities that will influence our internal team and motivate our CRO partners. The ideal candidate values bringing important medicines to patients in need, and shares our team’s determined, positive attitude.

Responsibilities:

• Broad view of the departmental goals and sees the “big picture” scientifically and strategically;
• Regularly interacts with Clinical Affairs and company leadership on matters concerning clinical development status;
• Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
• Efficient at clinical trial timeline and budget forecasting, using objective measures and tools to plan and communicate key clinical trial metrics;
• Exceptional planning, communication, and creative problem solving skills, ensuring trial delivery for one or more clinical trials.
• Leads by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.
• Ensures compliance of clinical trials with federal and applicable regulatory agency requirements.
• Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.
• Integrates best practices as appropriate.
• Represents Ironwood in external interactions.

Position Requirements:

• BS/MS in science or a health-related field is preferred;
• 4 - 6 years related work experience, at least 2 years in a study management role. Biopharmaceutical (Sponsor) organization experience is a must. CRO experience also desirable;
• Demonstrated effectiveness in resolving study management issues;
• Experience managing and training regional or consulting CRAs within project teams is required; direct line management is not required;
• In-depth knowledge of the CRO selection and contracting processes; 
• Superb communication skills; effective in objective data interpretation and communication as well as expression of abstract ideas to all levels of the organization;
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.

Position description:

Reporting to the Vice President and Chief Intellectual Property Counsel, the Senior IP Counsel will be responsible for developing strategies and creating and securing protection for company’s intellectual property. This person will work closely with in-house counsel, R&D, and senior management on pipeline programs and commercial products. 

Responsibilities:

• Counsel scientists and management in the development and protection of new intellectual property, including participating on project teams, evaluating invention disclosures, conducting prior art searches, and drafting patent applications;
• Collaborate with in-house and external counsel to create patent prosecution and litigation strategies, develop and manage existing patent portfolios, and monitor and analyze competitive intellectual property;
• Supervise outside counsel in the preparation and prosecution of pharmaceutical patent applications worldwide, and coordinate with external counsel to develop strategies for patent litigation and administrative patent challenges;
• Support business development and management on in-licensing opportunities and transactional work;
• Advise company on trademark and copyright matters;
• Work with internal clients and in-house counsel on IP-related contracts and agreements;
• Provide strong leadership and advice to internal clients. 

Requirements:

• Eight years or more of hands-on patent experience with strong skills in drafting and prosecuting patent applications in the pharmaceutical field;
• Substantial experience in IP due diligence, IP-related transactional work, patent litigation, and/or international patent portfolio management;
• USPTO registration;
• J.D. and bar admission in at least one state;
• Large law firm training and corporate experience within a life sciences company;
• Ph.D. in chemistry, biochemistry or pharmaceutical science, or B.S. or M.S. in chemistry with at least 5 years of work experience in medicinal chemistry or a related field;
• Strong written and oral communication skills.

Description:

We are seeking a talented, motivated, and goal-oriented individual to join Ironwood’s Program Management team. The successful applicant will play an important role in supporting Ironwood’s drug development teams in their quest to bring new human medicines to market. This individual will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific projects/programs, and to facilitate communication across all parties. The ideal candidate will have a scientific background and experience with clinical- stage drug development.  Experience in gastrointestinal disease is a plus.  This role is highly cross-functional, and may involve close interaction with external partners. This position will report to the Senior Director, Program Management.

Responsibilities:

• Serve as project/program manager for one or more drug development teams, providing leadership, coordination, and cross-functional communication to enable teams to meet their goals;
• Compile high-quality integrated cross-functional project/program plans, manage project activities, control timelines, and manage resources;
• Work with project/ program lead to facilitate decision making and resolve conflicts.
• Work with project/program lead and project/program team to identify key risks, timeline and resource constraints, and develop mitigation plans;
• Effectively communicate project/program strategy, status, critical path activity timing, resource requirements, and related issues and/or risks, both internally and to partners as appropriate;
• Manage and maintain the team SharePoint site.
• Effectively manage team meetings by defining and communicating meeting objectives, capturing and disseminating meeting outcomes/information/action items, and following up on critical actions with teams; 
• Facilitate the financial planning process, integrating inputs from functions and project/program teams into financial plans in collaboration with the Financial Planning & Analysis department.
• Help to create and improve program management tools and best practices. 

Requirements:

• A 4-year degree and a minimum of 3-5 years of relevant work experience including some project or program management.
• Able to express ideas and present information effectively within teams, functions, and with external partners.
• Demonstrate active listening and constructive feedback within team, ability to facilitate problem solving, decision making, and issue resolution.
• Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite.
• Strong program management skills: 
  • Communicating across the organization to align on shared goals and responsibilities
  • Working with teams to clarify vision and direction;
  • Developing work plans to meet goals;
  • Managing teams to meet goals and deliverables, tracking progress toward plan;
  • Highlighting areas of risk and developing mitigation plans;
  • Identifying options and facilitating decisions to enable projects to move forward;
  • Managing teams to develop budget, tracking progress towards plan
  • Ability to plan and facilitate effective, efficient meetings.
  • Experience in the following areas is a plus:
  • Clinical stage drug development;
  • Collaborating with external partners;
  • Gastrointestinal disease.

Role Description:

The Senior Manager, Search will  lead Ironwood’s business development effort to identify targets for product acquisition, in-licensing, joint ventures and other forms of external commercial asset acquisitions. This position is critical to the continued success of the company as we work to leverage our commercial infrastructure and grow our revenue base. A key member of a small BD team, the Senior Manager will focus on understanding external portfolio trends, divestments and identification of current and future asset acquisition opportunities that may include individual marketed products,  portfolios of products or companies.

Responsibilities include:

• Responsible for generating searches to identify assets of strategic interest to Ironwood.
• Manages consultants and projects required to support targeted searches.
• Plans and coordinates Ironwood’s Business Development participation in conferences and seminars.
• Monitors therapeutic opportunities including preparation for in-depth opportunity landscapes, attendance at scientific and partnering conferences.
• Partners with key internal stakeholders to identify key search criteria, and to implement search strategies that are well aligned with the commercial, financial, and corporate goals
• Communicates Ironwood’s Business Development strategy and key messages externally to search firms, consultants and other sources of product opportunity.
• Leads internal initiative to leverage existing networks and relationships of key Ironwood personnel to identify potential asset acquisition opportunities.
• Leads high level analysis of select opportunities/search targets for commercial assets.

Qualifications

• A minimum of a BA/BS is required with a major in business, finance or sciences preferred. Advanced degree preferred.
• Minimum of 4-6 years of experience in the pharma/biotech and or banking sectors.
• Previous experience in business intelligence, new product commercialization and or business development is desireable
• Ability to manage multiple priorities in fast-paced environment.
• A self-starter with the ability to develop and execute work-plans with minimal guidance.
• Ability to collaborate, influence and work with others in a dynamic, matrix environment.
• Must demonstrate strong interpersonal and communication skills with various levels of management and external stakeholders 

Are you able to think critically and creatively as part of a talented and fast-paced research team and play a key role in the companies growth? My biopharmaceutical client is looking for an exceptional Research Associate to contribute to the company’s efforts in building a high throughput platform.
If this  sounds like an opportunity for you, apply today!
Key Qualifications

• Bachelor’s or Master’s degree in organic, polymer, or food chemistry 
• Experience with up to date synthetic chemistry techniques (carbohydrate synthesis and analysis a plus)
• Experience with modern analytical and purification methods, including HPLC, mass spectrometry, and NMR spectroscope
• Excellent collaboration, communication and interpersonal skills

About StratAcuity
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Scientist - Fibrotic Disease

Location: Lexington MA

Promedior is seeking a Ph.D.-level research scientist to join ongoing efforts studying the role of PRM-151 (rhPTX-2) to treat chronic, progressive fibrotic diseases. The successful candidate will work in a highly collaborative and integrated research effort focused on molecular mechanism-of-action and new disease applications (NASH, ESRD) while contributing to biochemical and functional characterization of the recombinant protein.  The individual will support programs by planning and implementing in vitro and in vivo studies using both internal and external resources.

Essential Duties and Job Functions:

• Ability to work in a highly collaborative, project team-based research structure to lead or collaboratively support biological investigations regarding the role of pentraxin-2 in fibrotic disease at the molecular and cellular level.
• Oversee and/or directly manage new and established academic and industrial collaborations.
• Ability to operate within a larger group with efforts across a breadth of therapeutic areas and the successful candidate will also participate as an engaged member of this highly interactive and collaborate group.
• Utilize experience and understanding of modern molecular and cellular techniques to investigate intracellular signaling networks in monocytes/macrophages, an understanding of fibrotic disease, and use of in vitro cell-based assays and/or pre-clinical models to interrogate pathways.

Knowledge, Experience and Skills:

• PhD degree in pharmacology, immunology, molecular biology, biochemistry, or related field.
• At least 3 years of postdoctoral experience in academic medicine and/or pharma/biotech.
• Direct experience in the investigation of immune pathways that initiate/regulate fibrosis is optimal. Demonstrable skills and experience in hypothesis-driven biological research.
• The ability and desire to work collaboratively in a cross-functional and team-based environment is a key required attribute.
• Excellent communications skills – verbal and written – are required.

Interested candidates may apply by sending a CV/resume and a cover letter to jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age-related macular degeneration, diabetic nephropathy, non-alcoholic steatohepatitis (NASH), and several types of solid tumors. 

Promedior is an EEO employer

Scientist - Fibrotic Disease

Location: Lexington MA

Promedior is seeking a Ph.D.-level research scientist to join ongoing efforts studying the role of PRM-151 (rhPTX-2) to treat chronic, progressive fibrotic diseases. The successful candidate will work in a highly collaborative and integrated research effort focused on molecular mechanism-of-action and new disease applications (NASH, ESRD) while contributing to biochemical and functional characterization of the recombinant protein.  The individual will support programs by planning and implementing in vitro and in vivo studies using both internal and external resources.

Essential Duties and Job Functions:

• Ability to work in a highly collaborative, project team-based research structure to lead or collaboratively support biological investigations regarding the role of pentraxin-2 in fibrotic disease at the molecular and cellular level.
• Oversee and/or directly manage new and established academic and industrial collaborations.
• Ability to operate within a larger group with efforts across a breadth of therapeutic areas and the successful candidate will also participate as an engaged member of this highly interactive and collaborate group.
• Utilize experience and understanding of modern molecular and cellular techniques to investigate intracellular signaling networks in monocytes/macrophages, an understanding of fibrotic disease, and use of in vitro cell-based assays and/or pre-clinical models to interrogate pathways.

Knowledge, Experience and Skills:

• PhD degree in pharmacology, immunology, molecular biology, biochemistry, or related field.
• At least 3 years of postdoctoral experience in academic medicine and/or pharma/biotech.
• Direct experience in the investigation of immune pathways that initiate/regulate fibrosis is optimal. Demonstrable skills and experience in hypothesis-driven biological research.
• The ability and desire to work collaboratively in a cross-functional and team-based environment is a key required attribute.
• Excellent communications skills – verbal and written – are required.

Interested candidates may apply by sending a CV/resume and a cover letter to jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age-related macular degeneration, diabetic nephropathy, non-alcoholic steatohepatitis (NASH), and several types of solid tumors. 

Promedior is an EEO employer

Senior Accountant

Cambridge, MA

Job Summary:

As a key member of the Finance team at Blueprint Medicines, you will assist in the monthly close and financial reporting processes.  Ideally, you are a highly organized individual with strong attention to detail as well as a having a sound understanding of accounting, financial reporting and internal controls. If you enjoy working in a fast-paced and rapidly growing environment, this could be the opportunity for you!

Responsibilities:

• Assist in monthly close process, including preparation of monthly journal entries and account reconciliations
• Participate and prepare materials related to monthly accrual meetings with functional teams
• Participate in accounting for activities under existing and future collaboration agreements
• Assist in the preparation of monthly financial statements and analysis versus budget
• Assist in preparation of quarterly and annual SEC filings
• Provide support for quarterly earnings release process
• Assist in accounting related to administration of Company equity programs
• Assist in the development and maintenance of an effective system of internal controls and compliance with Section 404 of the Sarbanes-Oxley Act
• Work with external auditors on quarterly reviews and year-end audit
• Conduct technical accounting research and assist with special projects as may arise

Qualifications:

• Bachelor’s degree in Accounting
• CPA certification
• At least 3 years’ experience, preferably with a background in public accounting

Capabilities:

• Strong technical accounting skills and knowledge of US GAAP and financial reporting
• Ability to work under pressure and meet deadlines
• Strong analytical skills
• Well organized and detail oriented
• At home in a results-driven, highly accountable environment where you can make a clear impact
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner

All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

Manager, Laboratory Operations

Cambridge, MA

Job Summary:

As a key member of the Facilities team at Blueprint Medicines, you will provide full time oversight and management of our R&D laboratory environment.  Ideally, you are a highly organized individual with strong attention to detail that has a solid understanding of the activities, processes, and policies necessary for efficient and compliant laboratory operations. If you enjoy working in a fast-paced and rapidly growing environment, this could be the opportunity for you!

Responsibilities:

• Manage all laboratories to ensure compliance with internal quality systems, quality system regulations, GLP, OSHA, EPA and local, state, and federal environmental regulations
• Procurement of consumables management; including inventory control, reorder, and supply
• Manage equipment inventory and lab supply inventory control and stocking
• Development and maintenance of inventory tracking systems
• Manage equipment inventory, repair, and maintenance; including calibration and metrology, purchase new equipment, cleaning/decontamination/certifying as required, and disposal of outdate and non-functioning equipment
• Oversee and schedule environmental monitoring for environmentally controlled areas
• Oversee and schedule cleaning for environmentally controlled areas
• Develop effective relationships with scientific and operations staff to understand lab needs
• Oversee, coordinate, and track the hazardous chemical waste, biological waste, glass waste, plastic waste, and solid lab waste, ensuring the safe removal of all lab waste
• Manage the shipping and receiving of all lab samples and products, foreign and domestic shipments; ensuring that all local, state, and federal shipping codes are followed
• Record all and shipping and receiving documents and coordinate invoicing with the finance team
• Ensure and promote Good Lab Practices (GLP), including attendance to the EH&S Committee meeting and acting as a liaison to safety partners
• Supervise laboratory operations’ support resources
• Manage on-site visits from vendors as required
• Manage chemical inventory databases and safety data sheets
• Create and maintain applicable documentation and perform audits as necessary
• Create policies and procedures
• Champion efforts in contamination control

Qualifications:

• Bachelor’s degree in a life sciences or engineering discipline
• At least 10 years of experience working in a pharmaceutical/biotech laboratory environment
• Minimum of 4 years of experience managing a laboratory environment
• Employee Health and Safety experience with DOT and RCRA training would be a plus

Capabilities:

• Exceptional organizational, record-keeping and communication skills (verbal and written)
• Proactively identify new opportunities to improve lab safety and efficiency
• Must be able to lift/move up to 25 pounds
• Must be able to perform other work assignments; which may include lifting, bending, stooping, sitting, leaning, etc.
• At home in a results-driven, highly accountable environment where you can make a clear impact
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner

All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

Manager/Senior Manager, Statistician

Overview:

Celldex Therapeutics seeks an experienced biostatistician to join our company as Senior Manager, Statistician to support oncology drug development. This position will be based on-site in our Hampton, NJ office.

Position Responsibilities:  

• Provide statistical expertise in design, analysis, and clinical report for phase I, II, III oncology clinical trials.
• Represent biostat function in the clinical development team and interact with other function team members.
• Perform sample size calculation for continuous, dichotomous, and time to event endpoints in various study designs.
• Write the statistical section in protocol and prepare the statistical analysis plan (SAP).
• Lead internal biostat and programing team and provide statistical inputs to support the clinical study report for multiple clinical trials including planning, supervising, validating, and reviewing the statistical deliverables.
• Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs.
• Perform consistent statistical analyses to support publications in medical conferences.
• Review protocol, CRF, IVRS Specs, SAP, SDTM Specs, ADaM Specs, CSR, conference presentation, manuscript for publication, and other statistical documents.
• Participate in BLA/NDA submission activities as a key stat team member.
• Oversee and manage CRO statistical and programming activities.
• Contribute to the development of standard statistical documents including TLFs, SAP, Programming (ADaM) specs, SAS macros, and SOPs.

Required Skills:        

• Knowledge of FDA, EMA, and ICH guidance for drug development.
• Familiar with SDTM, ADaM, eSUB, CDISC requirements for regulatory submissions.
• Familiar with the concept of group sequential design, Simon’s 2-stage design, futility analysis, conditional power, survival analysis, CMH test, Fisher’s exact test, and exact binomial design
• Demonstrated ability to handle multiple priorities with timelines.
• Collaborate with other functions to resolve issues and improve efficiency.
• Excellent presentation skills to interpret statistical concepts and results to clinical development team.
• Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators.
• Familiar with statistical software SAS, R.

Education/Experience:

• PhD in Statistics or related field
• 4+ years of biopharmaceutical experience as a lead statistician
• 2+ years of oncology experience preferred
• Experience as a lead statistician handling Phase IIb/III clinical trials
• Experience with regulatory submissions to support integrated summary of Safety (ISS) / Efficacy (ISE) preferred
• Experience/Knowledge with adaptive/innovative study designs and multiplicity adjustment preferred
• Experience with drug development in biologics and targeted therapies preferred

Qualified candidates interested in applying for positions at Celldex should submit a resume and cover letter, identifying the specific position to careers@celldex.com. Celldex will make every effort to respond to inquiries from qualified applicants who have the skills and interests we are seeking. We will not be able to respond to recruiting & placement firms who contact us in an unsolicited manner, nor to unqualified applicants. Celldex is an equal opportunity employer dedicated to diversity in the workplace.

Manager/Senior Manager, Statistical Programmer Overview:

Celldex Therapeutics seeks an experienced statistical programmer to join our company as Senior Manager, Statistical Programmer leading multiple programming activities to support oncology drug development. This position will be based on-site in our Hampton, NJ office.

Position Responsibilities:  

• Lead the programming teams to support multiple in-house programming activities such as CSR programming, regulatory filings, adhoc analysis, publication requests, IB, DSUR, database pooling and reporting from multiple studies.
• Oversee the external programming activities outsourced to CROs to ensure the quality including standard programming practice, validation, and documentation.
• Review clinical study documents including CRF design, SDTM Specs, and edit checks.
• Contribute to develop and maintain a standardized programming process including SAS macros, programming specs (ADaM), and validation process.
• Utilize the SAS technical expertise or other programming skills to help build the programming infrastructure and tools.
• Contribute to the development of standard TLGs, ADaM Template, and other statistical documents.
• Train junior staff / team members including SAS technical expertise, regulatory guidance about clinical study data, and CDISC requirements.

Required Skills:        

• Excellent knowledge of SDTM, ADaM, eSUB, CDISC requirements for regulatory submissions.
• Expertise with data pooling to support Integrated Summary of Safety (ISS) / Efficacy (ISE).
• Ability to handle multiple priorities with multiple timelines.
• Excellent team player.
• Excellent written and verbal communication skills.

Education/Experience:

• MS in Statistics or related field
• 10+ years of biopharmaceutical experience as statistical programmer.
• 3+ years of oncology experience preferred
• Experience in regulatory submission(s)
• Experience as a project lead coordinating programming activities

Qualified candidates interested in applying for positions at Celldex should submit a resume and cover letter, identifying the specific position to careers@celldex.com. Celldex will make every effort to respond to inquiries from qualified applicants who have the skills and interests we are seeking. We will not be able to respond to recruiting & placement firms who contact us in an unsolicited manner, nor to unqualified applicants. Celldex is an equal opportunity employer dedicated to diversity in the workplace.