Medical Director, Clinical Development Physician

Role Summary

Medical Director, Clinical Development Physician – full-time role located in the US, with travel as needed. Lead late-stage clinical development programs and collaborate cross-functionally to shape initial registration and lifecycle management in oncology.

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.
• Work with senior management, steering committees, and line functions to develop protocols and amendments, provide medical monitoring of study conduct and oversight of patient safety, provide medical leadership for the DMCs, and provide medical support for data analysis/trial reporting.
• Serve as major 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 appropriate toxicity management based on protocol guidance and interface with the study team to provide medical guidance where needed.
• Direct clinical development strategies, collaborating with teams in the US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development and statistics to: develop Clinical Development Plan, support regulatory strategy, provide medical/scientific input and review clinical documents, supervise data review/interpretation, support communication of study results, and contribute to abstracts/manuscripts.
• 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 strongly preferred.
• Knowledge in global clinical oncology drug development; familiarity with preclinical oncology research methodology for FIH phase I planning; familiarity with INDs/CTAs; familiarity with CSRs/BLAs/NDAs preferred.
• Strong communication skills for one-to-one and large audience presentations; ability to be an internal program expert.
• Strong interpersonal skills, collaborative, and able to work in multidisciplinary teams.
• Creative, innovative, and self-starter.

Skills

• Medical leadership and strategic development of clinical programs
• Clinical trial design and oversight across multiple phases
• Regulatory strategy and interactions with authorities
• Data interpretation, publication writing, and communication of results
• Cross-functional collaboration across US, Europe, LatAm, and Asia

Education

• Medical degree; board certification/eligibility in Hematology/Oncology preferred.