Director, Medical Research - Pulmonary
Clinical Development Cambridge, MA
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 enables the generation of innovative compounds that engage the body’s ability toregulate 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. What’s in it for you?
Reporting to the VP of Medical Research/Pulmonary Therapeutic Area Head, the Director of Medical Research will provide medical leadership and guidance for Acceleron’s clinical development programs in the pulmonary therapeutic area. This position will support the overall program development strategy and program goals ensuring the highest scientific/medical standards are met, including the achievement of goals that are consistent with the 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.
What will you be doing?
- Initiating, communicating, and executing well-conceived clinical development plans in supportof 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 clinical trials in the pulmonary therapeutic area
- Ensuring that best practices are met to evaluate genomic, proteomic, metabolomics and biomarker tools in driving the development of significant, novel, targeted therapeutics
- Providing medical and scientific expertise on the use of novel biomarkers and potential companion diagnostic tests for the commercial and marketing strategy of the company projects
- Providing clinical input on all IND/NDA/BLA preparation activities including data collection, database lock, analysis and write-up of biomarker and pharmacodynamic endpoints
- Serving as the clinical interface with pre-clinical research, pharmacology, regulatory affairs; study investigators, scientific and clinical consultants
- Developing and implementing 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
- Communicating Acceleron’s clinical development goals and accomplishments to the external community, investigators, key opinion leaders and corporate partners
- Participating in, and provide clinical support to business development activities on an as-needed basis
What are we looking for?
- M.D. or M.D./Ph.D. degree required
- Subspecialty training and board eligibility/certification in pulmonary with or without critical care medicine preferred
- Prior experience (2-5 years) working in the biopharmaceutical industry and/or academic clinical research setting within pulmonary therapeutic area indications with a superb track record of accomplishments preferred
- Experience in participating and/or leading translational medicine programs for the submission of multiple INDs, and ideally through NDAs
- Strong strategic planning and product evaluation
- 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