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What’s in it for you?. The Associate Director of Clinical Quality Assurance (QA) will be responsible for providing QA support of clinical programs at Acceleron. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Research, Non-Clinical Development, and other functions to establish and document risk-based GCP processes and procedures. The AD of Clinical QA will ensure compliance with applicable regulations with regards to sponsor oversight of Acceleron’s clinical pro... view job details
What’s in it for you?. This role offers the right candidate an exceptional opportunity to join our legal group at a time when Acceleron is rapidly growing and moving to the next stage of the Company’s life cycle. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. We are seeking an experienced attorney to join Acceleron’s legal department. The primary focus of the position will be to provide commercial legal counsel relating to a broad range of activi... view job details
Who are we?. Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner,. Bristol-Myers Squibb. , are co-promoting newly appr... view job details
What’s in it for you?. Reporting to the VP, Corporate Controller, the Associate Director, Cost Accounting will initially be responsible for the build out of the Company’s functions for inventory and cost accounting while overseeing the existing manufacturing and CMC-related financial close activities. Upon Commercial Launch, this role will transition to leading the financial close accounting, analysis, and reporting for inventory and cost of goods sold. Additionally, the role involves working cross-functionally with the Financial Planning & Analysis, Supply Chain, IT, and Commercial departmen... view job details
What’s in it for you?. We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to be part of our success. In this role, you will focus on leading portions of the Global commercial strategy and key market development activities to support the Acceleron pipeline in pulmonary diseases, with a near term focus on Sotatercept in Pulmonary Arterial Hypertension (PAH) and future life cycle pulmonary indications. Reporting to the Global Commercial Head of Pulmonary, you will be able to apply your expertise and understanding... view job details
What’s in it for you?. Reporting to the Head of Medial Communication & Training, the Associate Director, Medical Information will be responsible for building and managing the Medical Information capability and providing oversight for the provision of scientific and medical information to address unsolicited inquiries from healthcare professionals and other stakeholders. What will you be doing?. Develop Medical Information strategy and plan, in alignment with global medical strategy. Develop medical materials related to the Medical Information function, including standard response letters (SRLs... view job details
Who are we?. Acceleron is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the trea... view job details
What’s in it for you?. The Associate Director, Pharmacovigilance (PV) Quality will be responsible for providing PV Quality support of clinical programs at Acceleron. This individual will be the subject matter expert in Good Pharmacovigilance Practice (GVP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Pharmacovigilance, Medical Research, PV Vendor(s) or Contract Research Organization(s), and other functions to establish and document PV processes and procedures. The AD of PV Quality will ensure compliance with applicable global regulations with regards to s... view job details
What’s in it for you?. We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to be part of our success. In this role, you will be a member of the sotatercept project team and will be responsible for coordinating two critical sub teams; the BLA/MAA submission sub team, and the life-cycle management sub team. Reporting to the Vice President – Program Management – Pulmonary, you will apply your expertise and understanding of drug development to integrate key functional activities, working closely with individuals fro... view job details
What’s in it for you?. We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team-oriented, and collaborative environment to join the Program Management team and drive projects from research through early clinical development. The ideal candidate will be responsible for actively managing highly technical, cross functional teams to ensure the advancement of programs, managing program scope, timelines, deliverables, risks, decisions and alignment with senior leadership. The candidate will possess a breadth and depth of expertise spanning research through earl... view job details