Acceleron Pharma, Inc. is a public American "clinical stage biopharmaceutical company" based in Boston, Massachusetts with a broad focus on developing medicines that regulate the transforming growth factor beta (TGF-ß) superfamily of proteins, which play fundamental roles in the growth and repair of cells and tissues such as red blood cells, muscle, bone, and blood vessels. John Knopf, Jasbir Seehra, Tom Maniatis, Mark Ptashne and Wylie Vale formed the company in Cambridge, Massachusetts. Wikipedia
Acceleron Pharma, Inc. is a public American "clinical stage biopharmaceutical company" based in Boston, Massachusetts with a broad focus on developing medicines that regulate the transforming growth factor beta (TGF-ß) superfamily of proteins, which play fundamental roles in the growth and repair of cells and tissues such as red blood cells, muscle, bone, and blood vessels. John Knopf, Jasbir Seehra, Tom Maniatis, Mark Ptashne and Wylie Vale formed the company in Cambridge, Massachusetts. Wikipedia
Technical expertise in functional structural biology using known structures or homology based models to confer new molecular properties to solve protein aggregation issues, altering protein binding and/or specificity is essential
Oversee Quality Assurance and Quality Control functions across all GXP processes. Acceleron operates an in-house GMP drug substance manufacturing facility for therapeutic proteins. Though GMP compliance is a large part of the job function, the VP Quality Systems will be responsible for overseeing GCP and GLP requirements across the company
Develop and lead Medical Affairs plans in support of our therapeutic areas as we continue to move our drug candidates through clinical development and commercialization
Integrating with broader Commercial team to clearly understand key business questions; formulating plan to utilize market research and secondary data sources to address key questions with actionable insights
Develop and implement ongoing projects with agreed upon strategic goals, product profiles, product development plans, and project plans to meet milestones and timelines en route to full development
Authoring and reviewing relevant CMC sections for regulatory filings (e.g. IND, IMPD, and BLA) as well as provide technical oversight for responses to regulatory agency comments/recommendations
Providing expertise on compliance for company's potential future commercial programs, identifying and managing complex legal and regulatory issues, analyzing alternatives and proposing solutions.
Provide expert guidance in the design and implementation of drug development programs for Preclinical Pharmacology based on a broad knowledge of the drug development process and demonstrated knowledge of pharmacology in neuromuscular and pulmonary therapeutic areas.
Provide expert guidance in the design and implementation of drug development programs for Preclinical Pharmacology based on a broad knowledge of the drug development process and demonstrated knowledge of pharmacology in neuromuscular and pulmonary therapeutic areas.
This individual will be responsible for providing strategy, expertise, resources and guidance to a dedicated group of scientists which constitutes the molecular and cell biology and protein expression functional groups.
Will review upcoming DM deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming DM activities within timeline and budget requirements.
Annual Report