Medical Director, Clinical Development Physician

Role Summary

Medical Director, Clinical Development Physician. Full-time role located in the US, with travel as needed for business meetings and on-site visits. Works closely with cross-functional clinical development teams including Clinical Operations, Safety, Regulatory, and Statistics, primarily across late-stage programs and potential early-stage 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.
• Collaborate with senior management, steering committees, and line functions to develop protocols and amendments; monitor study conduct and patient safety; provide medical leadership for data monitoring committees and support data analysis/trial reporting.
• Serve as main point of 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 as needed.
• Direct clinical development strategies with teams across the US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development, and statistics.
• Support development of and propose the Clinical Development Plan; support regulatory strategy.
• Provide medical/scientific input and develop/review clinical documents to ensure high quality materials (study concept sheets, protocols, investigator brochures, submission documents, publications, etc.).
• 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.
• Review clinical documents for own programs as a reviewer.

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 strongly preferred.
• Knowledge and experience in global clinical oncology drug development.
• Familiarity with preclinical oncology research methodology to interpret preclinical data for FIH phase I planning.
• Familiarity with preparing INDs and CTAs; familiarity with preparing/reviewing CSRs, BLAs, and/or NDAs preferred.
• Strong communication skills for one-to-one and large-audience presentations; ability to serve as an internal program expert.
• Strong interpersonal, collaborative, and multidisciplinary teamwork skills; creative, innovative, self-starter attitude.

Skills

• Medical leadership for oncology clinical trials
• Regulatory strategy and interaction with authorities
• Clinical data analysis and interpretation
• Publication planning and scientific writing
• Cross-functional collaboration across global teams

Education

• Medical degree; board certification/eligibility in hematology/oncology preferred.

Additional Requirements

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