Executive Director/Vice President, Medical Lead

Role Summary

Crescent Biopharma is seeking a Medical Lead to provide clinical leadership for one or more programs from preclinical through clinical development. This individual will own the medical strategy, lead study design and execution, and serve as the clinical face of the program with investigators, partners, and internal teams. This is a hands-on role in a dynamic startup environment.

Responsibilities

• Develop and implement the clinical development strategy and target product profile for assigned program(s).
• Lead the design, initiation, and execution of early-phase clinical studies, including protocol and investigator brochure development, endpoint selection, and dose-escalation strategies.
• Serve as the medical monitor of ongoing studies, ensuring subject safety, high-quality data collection, and adherence to GCP and regulatory standards.
• Interpret and communicate emerging data across internal and external stakeholders, contributing to clinical study reports, publications, and presentations.
• Contribute clinical content for regulatory submissions, including IND/CTA filings, amendments, and briefing documents; support interactions with health authorities.
• Partner closely with cross-functional colleagues in nonclinical, translational, clinical operations, regulatory, program management and CMC to align program objectives and milestones.
• Build and maintain relationships with key opinion leaders, clinical investigators, and partners to inform study design and program direction.

Education & Experience

• MD (or equivalent) with clinical training in oncology, immuno-oncology, or a related medical specialty.
• Minimum of 7 years of experience in the life sciences industry, including substantial oncology-focused medical oversight responsibilities.
• Hands-on experience in biotech environment with antibody‚Äìdrug conjugates (ADCs) or other targeted biologic therapies and preferred.
• Demonstrated experience in clinical drug development, with deep understanding of trial design, execution, and data interpretation in biotech or biopharma settings.
• Proven track record authoring clinical trial documents (protocols, IBs, CSRs) and contributing to regulatory submissions (IND, CTA, amendments, briefing books).
• Strong knowledge of regulatory agency guidelines (FDA, EMA, ICH-GCP) and experience supporting GCP audits or regulatory inspections related to clinical trial conduct.
• Exceptional analytical and communication skills, with the ability to synthesize complex data into clear, actionable insights.
• Recognized for strong leadership, cross-functional collaboration, and relationship-building skills with both internal and external stakeholders.
• Self-motivated, detail-oriented, and adaptable, with a proactive approach to problem-solving and execution in a fast-paced environment.

Skills

• Clinical development strategy; trial design and execution; data interpretation; regulatory submission support; stakeholder communication; cross-functional collaboration; leadership.