Medical Director (Waltham)

Our Waltham based biotech client is seeking an experienced clinical development physician to support the design, execution, and medical oversight of early‑stage oncology trials. This role involves clinical document authorship, medical data review, safety oversight, and scientific input that shapes ongoing and future development programs. The position requires strong clinical judgment, deep oncology expertise, and the ability to collaborate effectively with global teams and external partners.

Responsibilities

• Author clinical protocols and contribute to clinical study reports, IBs, IND summaries, CTAs, ICFs, training materials, and other regulatory documents.
• Perform medical and safety/efficacy data reviews with minimal oversight; analyze clinical data, identify issues, and provide preliminary assessments and recommendations.
• Prepare and communicate clear summaries of trial results for internal presentations, publications, and regulatory submissions.
• Manage drug safety and pharmacovigilance activities for assigned trials.
• Participate in and support clinical site initiation visits.
• Integrate new clinical and scientific insights into development plans and trial execution.
• Collaborate with research leadership and discovery teams to inform portfolio strategy.
• Support data monitoring activities, meeting preparation, adjudications, and synthesis of data reports.
• Build strong relationships with study sites, vendors, committees, and internal stakeholders; triage and escalate questions as needed.
• Ensure the highest standards of compliance, ethics, and data integrity in trial conduct and communication.
• Conduct literature reviews to support clinical and scientific decision‑making.

Background & Requirements

• MD, MD/PhD, or advanced clinical degree with 5+ years of clinical development experience in industry.
• At least 3 years of oncology clinical development experience in biotech or pharma.
• Experience with global early‑stage oncology trials is required.
• Strong background in trial design, protocol development, CRF development, and statistical analysis plan review.
• Direct experience working with investigative sites and clinical trial personnel.
• Excellent written and verbal communication skills.
• Ability to work flexible hours with teams and sites across EU and Asia; travel as needed.