Medical Director, Clinical Development Physician

Role Summary

Medical Director, Clinical Development Physician. Full-time role located in the US with travel as needed. Works closely with cross-functional clinical development teams across late-stage programs and potential early-stage development, guiding clinical strategies and lifecycle management post-approval.

Responsibilities

• Provide medical leadership for assigned clinical trials/programs including phase 1b/II, full phase 2 single arm studies and phase 3 randomized controlled studies.
• Collaborate with senior management, steering committees, and line functions to develop protocols and amendments, monitor study conduct and patient safety, lead DMCs, and support data analysis and trial reporting.
• Serve as primary contact with internal management, investigators, health authorities, IEC/IRB, consultants, thought leaders, and academic institutions for assigned programs.
• Assess eligibility packets, advise investigators on toxicity management per protocol, and provide medical guidance to study teams and investigators as needed.
• Direct clinical development strategies with team members across US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development and statistics to:
• Support the Clinical Development Plan and regulatory strategy.
• Provide medical/scientific input and develop/review clinical documents to ensure high quality study concept sheets, protocols, reports, Investigator Brochures, submission documents, and publications.
• Supervise review, analysis and interpretation of study data; support communication of study results as assigned.
• Write abstracts and manuscripts for publication of clinical data in collaboration with clinical scientists and external providers as applicable.
• Act as a reviewer for clinical documents for own programs.

Qualifications

• Medical degree and training from a recognized academic institution. Board Certified/Board Eligible Hematologist/Oncologist preferred.
• 2+ years of experience in Oncology Clinical Development in industry contributing to the management of clinical trials.
• Clinical experience in Oncology or Malignant Hematology with direct patient care in solid tumor/hematology malignancies is strongly preferred.
• Knowledge and industry expertise in global clinical oncology drug development.
• Familiarity with preclinical oncology research methodology to interpret preclinical data for FIH phase I hypotheses and clinical planning; familiarity with INDs and CTAs if helpful.
• Familiarity in preparing/reviewing CSRs, BLAs and/or NDAs is preferred.
• Strong communication skills in one-to-one and large-audience settings; comfortable as an internal expert on own program.
• Strong interpersonal skills, collaborative, and able to work in multidisciplinary teams.
• Creative, innovative, and a self-starter.

Skills

• Medical leadership
• Clinical trial design and oversight
• Regulatory strategy and interaction with authorities
• Data analysis and interpretation
• Scientific writing and publication planning
• Cross-functional collaboration

Education

• Medical degree from a recognized institution; board certification/eligibility in Hematology/Oncology preferred.

Additional Requirements

• Ability to travel as needed for business meetings and on-site visits.