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
Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements; performing literature searches, preparing special reports and assembling documentation to support project teams.
Leading and supporting teams in a matrix management environment, working towards proactive risk management; developing risk management programs and integrates them into quality systems.
Build and lead the Medical Affairs function in order to provide scientific and medical leadership by thoroughly understanding relevant disease areas and serving as a key medical resource for our programs.
Coordinate with external vendors on timing, execution and renewal/implementation of service contracts and work instructions; develop long range plan to address obsolescence of equipment and replacement strategy, including budgeting, procurement, delivery and installation.
Performing quality oversight on the ICSRs, ensuring consistency in the case evaluation and assessment of adverse event reports from all source documentation for completeness, accuracy and succinctly summarizing case narrative in the ICSR.
Developing clear and effective marketing plan to maximize revenue for luspatercept in MDS and beta-thalassemia; creating digital and tactical marketing as well as scientific conference programs in support of marketing strategy.
Seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to be part of our success.
Working as part of an integrated drug development team, you will contribute to the clinical strategy and creation of the clinical development plans for pulmonary indications for one or more drugs.
Participating on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content.
Responsible for the strategic and operational medical input to the design, planning, initiation, completion, analysis and reporting of clinical trials in the pulmonary therapeutic area.
Maintain a high level of clinical and scientific knowledge in relevant disease areas through literature, medical and scientific meetings, and relationships with external collaborators and thought leaders.
Annual Report