Director, Medical Research - Neuromuscular

Less than 5 years experience  • 

Salary depends on experience
Posted on 03/20/18
Cambridge, MA
Less than 5 years experience
Salary depends on experience
Posted on 03/20/18

Director, Medical Research - Neuromuscular

Clinical Development  Cambridge, MA

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Description

Who are we? Acceleron is a Cambridge-based, 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 treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension. Position Overview:

Reporting to the VP of Medical Research, the Director of Medical Research will provide medical leadership and guidance for Acceleron’s clinical development programs in the neuromuscular therapeutic area.  This position will support the programs’ overall development strategy and goals, ensuring the highest scientific/medical standards are met, including the alignment with overall corporate vision, mission and objectives.  The Director of Medical Research also be responsible for the incorporation of translational medicine strategy to facilitate the rapid and effective bridging of results in the research laboratory to patients in clinical studies. 

Job Responsibilities: 

  • Initiate, communicate, and execute well-conceived clinical development plans in support of the discovery, development and commercial mission of Acceleron
  • Responsible for the strategic and operational medical input to the design, planning, initiation, completion, analysis and reporting of Phase 1-3 clinical trials for neuromuscular program
  • Serve as Medical Monitor on one or more Phase 1-3 studies for neuromuscular programs
  • Interact with clinical operations, biometrics, clinical pharmacology, regulatory and market development groups regarding planned and ongoing neuromuscular clinical trials.
  • Interact with discovery research, preclinical pharmacology, and preclinical safety groups onrelated neuromuscular programs
  • Provide medical and scientific expertise on the use of novel biomarkers and imaging methods for implementation in clinical trials
  • Provide clinical input on all IND, protocol, and NDA/BLA preparation activities, including data collection, data analysis and write-up of safety, efficacy, biomarker, pharmacokinetic, and pharmacodynamic endpoints
  • Serve as the clinical interface with study investigators, and communicate Acceleron’s clinical development goals and accomplishments to the external community, including scientific and clinical consultants, key opinion leaders, and corporate partners
  • 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
  • Participate in, and provide clinical support to business development activities on an as-needed basis
  • Partner with Pharmacovigilance to assess safety for assigned programs
  • 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

Basic Qualifications:

  • M.D. or M.D./Ph.D. degree required
  • Subspecialty training and board eligibility/certification in neuromuscular
  • Prior experience (≥ 3 yearsworking in the biopharmaceutical industry and/or academic clinical research setting as investigator in industry-sponsored clinical trials within neuromuscular field, with a superb track record of accomplishments preferred
  • Understanding of endpoint validation and selection, and biostatistical methods for study design and analysis
  • Experience in or full understanding of how to lead translational medicine programs to IND stage and clinical development
  • Strong strategic planning and product evaluation skills
  • Knowledge of global regulatory and cGCP standards
  • Superb verbal and written communication and presentation skills
  • Excellent interpersonal, motivational and collaboration skills
  • Entrepreneurial spirit; comfortable with rapid change, resource constraints, and the need tobe flexible about roles
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