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Crescent Biopharma

Posted 3 months ago

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Executive Director/Vice President, Medical Lead

Waltham, MAOn-siteFull-time

AI Summary

Provides clinical leadership for one or more oncology programs from preclinical through clinical development. Owns medical strategy, study design and execution, and serves as the clinical face to investigators, partners, and internal teams in a dynamic biotech environment.

About this role

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking a Medical Lead to provide clinical leadership for one or more programs from preclinical through clinical development. You 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 suited for someone who thrives 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–drug 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.

    • What We Offer

  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
  • Competitive compensation, including base salary, performance bonus, and equity.
  • 100% employer-paid benefits package.
  • Flexible PTO.
  • Two, one-week company-wide shutdowns each year.
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

    • Skills

    ADCAntibody–drug ConjugatesClinical Study ReportsClinical Trial DesignCTAGCPImmuno-oncologyINDInvestigator BrochureOncology

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