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Senior Clinical Scientist/Associate Director, Clinical Sciences
Cambridge, MA, US
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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 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, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.
What’s in it for you?
We are seeking a talented and passionate individual to join our dynamic clinical team. In this role, you will be responsible for providing scientific support for clinical development activities for drug products in pulmonary diseases. Reporting to the Senior Director of Clinical Science, you will collaborate closely with the pulmonary Medical Director, clinical pharmacology, program management, clinical operations, biostatistics, and data management groups. This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, assisting with writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. Responsibilities will also include biomarker analysis, data review and trial startup activities for future studies.
You will contribute to the creation and maintenance of a clinical development plan for sotatercept and other potential drug candidates in pulmonary disease. Applying your strong scientific background with a focus in pulmonary disease and translational medicine, you will clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internally and externally. Someone who can think creatively, function independently, has good strategic insights and knowledge of the activities and procedures involved in clinical drug development and translational science, while having fun along the way, would be a great fit for our group!
What will you be doing?
Providing scientific input to clinical trial protocol development and helping define efficacy and safety endpoints for all pulmonary studies
Participating in the generation of case report forms for future studies to ensure we are collecting all necessary information in the most appropriate way
Understanding competitive landscape and providing insights on strategic development pathways
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
Collaborating with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
Preparing data and contributing to scientific publications including posters, abstracts and manuscripts
Supporting the Medical Monitor with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals
Participating in the identification of appropriate external investigators and consultants
Anticipating potential study problems and preparing contingency plans as needed
Developing and cultivating relationships with external partners such as clinical investigators, clinicians, scientists, and vendors
Providing support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations
Proactively seeking out and recommending process improvements
Communicating clearly and precisely with all levels of the company globally
Providing scientific input to the preclinical pharmacology team for translational studies of interest including biomarker development strategies
What are we looking for?
MD, PhD or PharmD, or equivalent with clinical research experience
At least 2-5 years of technical/operational experience in planning, executing, reporting and publishing clinical studies
Strong scientific background, with clinical and/or research experience in pulmonary disease (e.g. pulmonary arterial hypertension)
Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 3 clinical studies
Familiarity with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
Strong analytical and strategic thinking skills
Experience interacting with clinical investigators and medical experts
Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)
Willingness to travel up to 10%
How will you grow with us?
As a member of our small and driven clinical sciences group, you will actively contribute to bringing our pulmonary drug candidates through the clinic. You will have the opportunity to further our programs by sharing your expertise as well as learn from others by working closely with multiple cross-functional groups. Our fast-paced environment and innovative spirit will provide the opportunity for you to have valuable, hands-on experience to develop your skills and grow in your career. If you are looking for a role where you will work alongside fun and passionate team members while helping us in our mission of transforming the lives of patients, then join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
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