Senior Manager, Clinical Operations Acceleron Pharma
THIS JOB HAS EXPIRED About Acceleron:
Founded in 2003, Acceleron Pharma, Inc. is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. We have internally discovered and developed 4 products that have entered into human clinical trials. Acceleron has raised over $130M in venture financing and secured an additional $180M from collaborations with Celgene Corporation, Alkermes, and Shire. Acceleron?s scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF--- protein superfamily. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company?s internal GMP manufacturing capability to advance its therapeutic programs rapidly and efficiently. The investors in Acceleron include Advanced Technology Ventures, Alkermes, Bessemer Ventures, Celgene, Flagship Ventures, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock.
We are seeking talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success.
With minimal supervision, responsible for designing, planning, managing execution and reporting of ongoing clinical projects according to ICH GCP and Acceleron SOPs within agreed time frames and budget.
Manage implementation of the clinical study operations by organizing and coordinating with other relevant parties (e.g. internal functions, CRO, etc.) initiation, management and completion of clinical studies in a timely and efficient manner meeting ethical and medical requirements, as well as corporate and development timelines.
Ensure all study activities are completed in accordance with ICH GCP, health authority regulations and Acceleron SOPs.
Authors and/or reviews the clinical sections of IND submissions, IND annual reports, investigator brochure updates, BLA/NDA submissions.
Leads cross functional clinical teams at the study levels.
Authors and drives completion of the protocol synopsis, final protocol and template informed consent form.
Develops outsourcing specifications for vendor requests for proposal and negotiates scope of work agreements; participates in and guides study team in vendor selection and management throughout the life of assigned clinical projects. Proposes vendors to senior management for approval.
Works with study team to determine patient recruitment strategies and operational feasibility and implementation of study objectives.
Authors and maintains study plans and clinical monitoring plan. Provides oversight of CROs for any outsourced clinical operations activities.
Manages and communicates to senior management overall clinical operations plan for projects including timelines, internal and external resources/costs, and key deliverables.
Plans, convenes, runs and presents at investigator meetings.
Reviews abstracts, posters and presentations for scientific meetings.
Manages site selection, initiation, and study start activities including drafting of study site agreements and negotiating budgets.
Develops and manages study timelines.
Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues.
Coordinates and drives completion of the clinical study report.
Authors, reviews and revises Clinical Operations Standard Operating Procedures (SOPs).
Mentor operations personnel (e.g. junior CTM, CRC, etc.). Provide performance feedback as needed.
BA/BS (preferably in industry or healthcare of science field) with a minimum of 7 years progressive experience in clinical operations including site management and site monitoring.
Thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs is preferred.
Ability to handle a high volume of highly complex tasks within a given timeline.
Ability to lead a cross-functional team in a matrix environment.
Excellent interpersonal and negotiation skills.
Strong verbal and written communication and presentation skills.
Requires strong organizational and leadership skills and ability to prioritize.
Must build relationships across and up and down the organization.
Proven problem solving and decision-making skills.
Strong leadership, planning and project management skills, including risk assessment and contingency planning.
Ability and willingness to travel 5-10% of the time (international and domestic).
||149 Sidney Street |
Cambridge, MA 02139
THIS JOB HAS EXPIRED