Clinical Research Director - Oncology

Role Summary

Clinical Research Director - Oncology based in Cambridge, MA or Morristown, NJ. Lead the clinical trial strategy for multiple myeloma assets within Oncology, coordinating across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish and execute the development plan. Senior CRD responsibilities include shaping development strategy and providing expert medical guidance to cross-functional teams.

Responsibilities

• Working within a matrix model, establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors and regulatory authorities.
• Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans.
• Lead the clinical interpretation of study results
• Contributes to clinical study reports and clinical summaries, including regulatory submissions.
• Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial
• Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities
• Author clinical abstracts, presentations for conferences, and manuscripts

Qualifications

• Required: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies
• Experience: At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution

Skills

• Excellent communication skills (verbal and written English) with both internal and external stakeholders
• Adept at problem solving
• Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach
• Demonstrated ability to work with a multi-functional team to achieve project milestones
• Understanding of and willingness to meet applicable regulatory, quality and compliance standards
• Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions
• International/ intercultural working skills

Education

• Medical Doctor (MD) or equivalent; oncology/hematology training