Medical Director, Clinical Development Physician

Role Summary

Medical Director, Clinical Development Physician — full-time role located in the US with travel as needed. Works across late-stage clinical programs and potential early-stage development, leading one or more clinical studies through filing and post-approval lifecycle management in collaboration with Medical Affairs.

Responsible for cross-functional strategic development plans for initial registration and beyond in the US and globally, partnering with Clinical Operations, Safety, Regulatory, and Statistics to drive clinical development.

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.
• Develop protocols and amendments with senior management, monitor study conduct, oversee patient safety, lead DMCs, and support data analysis/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 the study team and investigators as needed.
• Direct clinical development strategies, coordinating with teams in the US, Europe, LatAm, and Asia across 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 (study concept sheets, protocols, reports, Investigator Brochures, regulatory submissions, publications, etc.)
• Supervise review, analysis, and interpretation of study data
• Support communication of study results as assigned
• Write abstracts and manuscripts for publication 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 tumors/hematology malignancies preferred.
• Knowledge of global clinical oncology drug development; familiarity with preclinical oncology research methodology for FIH phase I planning.
• Familiarity with INDs and CTAs; familiarity with CSRs, BLAs, and/or NDAs preferred.
• Strong communication skills, ability to present to large audiences and act as internal program expert.
• Strong interpersonal skills, collaborative, and able to work in multidisciplinary teams.
• Creative, innovative, and a self-starter.

Skills

• Strategic clinical development planning
• Medical leadership for clinical trials across multiple phases
• Regulatory strategy and scientific documentation
• Data interpretation, trial reporting and publication writing
• Cross-functional collaboration across global teams

Education

• Medical degree; Board Certification/Eligible in Hematology/Oncology preferred

Additional Requirements

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