Clinical Research Director - Oncology

Role Summary

Senior Clinical Research Director in the Oncology Therapeutic Area responsible for leading the clinical trial strategy for one or more multiple myeloma assets. Collaborates across Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning, and Pharmacovigilance to establish and execute development plans. Location: Cambridge, MA or Morristown, NJ (preferred); other listed locations may be considered.

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.
• Contribute to clinical study reports and clinical summaries, including regulatory submissions.
• Provide expert medical guidance to other functions to ensure optimal planning and execution of clinical trials.
• 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.
• Required: At least 4 years of 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; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies.