Sr. Director Clinical Development

Job Description

Sr. Director- Clinical Development (Oncology)

Join a growing biotech company and play a pivotal role in the clinical development for an oncology program. This is an exciting opportunity to lead cutting-edge oncology research and contribute to advancements in cancer treatment.

Responsibilities

• Lead and oversee the clinical development strategy and development for oncology therapy, ensuring successful study design and execution across late stage studies.
• Act as the medical monitor for clinical trials, providing expert guidance and ensuring trials are conducted in compliance with regulatory standards.
• Align scientific rigor, medical need, and commercial value within clinical plans, effectively manages tight timelines to achieve successful registration and market launch.
• Provide medical leadership on the scientific and clinical aspects of the oncology therapy program.
• Provide expert medical insights for regulatory interactions and submissions with health authorities (e.g., FDA, EMA).
• Contributes to the strategic oversight and leadership of clinical development, guiding the process from proof of concept to BLA and/or NDA submission.
• Serve as the key medical liaison for investigators, key opinion leaders (KOLs), and clinical research organizations (CROs) in the oncology field.
• Lead discussions on clinical strategies for advancing the oncology asset, including future business opportunities and initiatives to determine new areas of scientific study to expand the pipeline.
• Provide direction, mentorship and follow-up to ensure compliance with department and corporate policies and procedures.

Requirements

Educational Background: Medical Doctor (MD/DO) degree is required

Clinical Experience: At least 8-10 years of experience in clinical development, ideally in a pharmaceutical or biotechnology setting. Strong understanding of clinical methodology and protocol development for clinical trials is required.

Leadership Experience: 5-6 years of experience leading clinical development teams

Therapeutic Area: In-depth knowledge and experience in oncology is required. Experience with early and late-stage oncology products, clinical trials, and treatments is preferred.

Regulatory Knowledge: Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP) and experience with clinical trial submissions, INDs, NDAs, and BLAs.