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, providing medical leadership and strategy for registered development and lifecycle management.

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, (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions for assigned programs for which the Clinical Development Physician has primary responsibility.
• Assess eligibility packets, advise investigators on appropriate toxicity management based on protocol guidance and interface with the study team and investigators to provide medical guidance where needed.
• Act as director of clinical development strategies, working with team members in the US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development and statistics to:
  • Support development of and propose the Clinical Development Plan
  • Support the regulatory strategy
  • Provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of: study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  • Supervise the review, analysis and interpretation of study data
  • Support communication of study results as assigned
  • Write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientists and external providers, as applicable
  • Act as a reviewer for clinical documents for his/her 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.
• Some knowledge and industry expertise in global clinical oncology drug development.
• Familiarity with preclinical oncology research methodology to enable interpretation of preclinical data for devising FIH phase I clinical hypotheses and clinical planning purposes.
• Familiarity with preparing INDs and CTAs if helpful.
• Familiarity in preparing/reviewing CSRs, BLAs and/or NDAs is preferred
• Strong communication skills in one-to-one situations and presentation to large audiences in addition to comfort serving as an internal expert on their program.
• Strong interpersonal skills with an outgoing, collaborative nature.
• Ability to work in multidisciplinary teams.
• Creative, innovative and a self-starter.

Skills

• Strategic clinical development planning
• Medical monitoring and safety oversight
• Regulatory strategy and communication with authorities
• Scientific writing and publication planning
• Cross-functional collaboration across global teams

Education

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