Senior Medical Director/ Medical Director, Oncology Clinical Development

Position Purpose:

The Senior Medical Director/Medical Director, Oncology Clinical Development, will be a key contributor to the Oncology / CAR -T programs. This individual will participate in clinical development activities for the organization’s oncology program and for future indications. This individual will monitor clinical studies, review, and interpret clinical trial data, and contribute to clinical study documents and communications. This position will report into the Vice President, Oncology Clinical Development.

Key Responsibilities:

• Develop clinical study protocols across Oncology or Immunology indications.
• Contribute to the clinical content of clinical and regulatory documents for Oncology programs including INDs, CTAs, investigator brochures, CRFs, CSRs, NDAs, MAAs, and annual IND reports.
• Lead clinical trials in Oncology indications under supervision of the Vice President, Oncology Clinical Development, collaborating closely with the Clinical Operations team.
• Interact with senior management and serve as a standing member of project team meetings.
• Participate in analysis of clinical data, including safety monitoring in collaboration with Pharmacovigilance.
• Develop and maintain relationships with key opinion leaders and Principal Investigators.
• Organize and lead relevant clinical advisory boards.
• Draft and/or Review manuscripts, publications, or other documents intended for external audiences.
• Help to ensure Clinical Study Team compliance with FDA, EMA, PMDA, ICH and GCP guidelines and internal SOPs.

Required Skills & Experience:

• MD or MD/PhD.
• Board certified or eligible in a medical or pediatric specialty preferred.
• Expertise in Oncology or Pediatric Oncology preferred.
• At least 5 years of experience in an industry setting. Substantial experience working on industry-sponsored trials will be considered.
• Knowledge of FDA/EMA requirements, good clinical practice, and pharmaceutical clinical development.
• Ability to work independently and collaboratively, as required, in a fast-paced environment consisting of internal and external team members.
• Excellent written and verbal communication skills to meet the needs of varied audiences.
• Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Senior Medical Director/ Medical Director, Oncology Clinical Development