Medical Director

Job Description

Medical Director, Clinical Development (Oncology)
Location: US Remote

A global, innovation-driven biopharmaceutical company is seeking a Medical Director of Clinical Development to support the advancement of a broad clinical pipeline focused on oncology. With a robust portfolio of approved and late-stage assets, this company is committed to developing high-quality and accessible biologics for patients worldwide.

Position Overview

Reporting to senior leadership within the Clinical Development function, the Medical Director will contribute to clinical development strategy and execution for clinical-stage programs. This role will focus on the medical and scientific oversight of clinical trials from design to regulatory submission. The ideal candidate will bring strong cross-functional collaboration skills and deep expertise in oncology drug development.

Key Responsibilities

Clinical Development & Strategy

• Act as a key medical contributor to clinical development plans and clinical trial strategy across assigned oncology programs.
• Provide scientific and medical input on trial design, endpoints, and patient population selection.
• Represent the medical function in scientific meetings, advisory boards, and cross-functional project teams.

Trial Execution & Oversight

• Ensure medical governance, protocol adherence, and safety oversight for assigned clinical studies.
• Support patient recruitment strategies, investigator relationships, and medical issue resolution during trials.
• Review and contribute to clinical documents including protocols, IBs, CSRs, and regulatory filings.

Cross-Functional Collaboration

• Work closely with Clinical Operations, Regulatory Affairs, Safety, Program Management, and external CRO partners to ensure smooth trial execution.
• Provide medical support to internal and external stakeholders, including during site selection and initiation.

Regulatory & Safety Responsibilities

• Support the preparation of regulatory documents (e.g., INDs, NDAs) and participate in interactions with global health authorities as needed.
• Ensure compliance with GCP, ICH, and applicable regulatory guidelines.

Stakeholder Engagement

• Collaborate with external experts, investigators, and KOLs to gather input on program strategy and study design.
• Represent the company in external scientific forums and industry conferences as appropriate.

Qualifications

Required:

• Medical Degree (MD), with board certification in Oncology preferred or strong oncology clinical development experience.
• Minimum of 6–8 years of experience in clinical development within the biotech or pharmaceutical industry.
• Experience supporting global clinical trials and working with cross-functional teams.
• Solid knowledge of GCP, ICH, and global regulatory requirements (FDA, EMA).
• Excellent communication and data interpretation skills, with the ability to synthesize complex scientific information.

Preferred:

• Experience in thoracic oncology.
• Prior involvement in regulatory submissions and agency meetings.

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