Executive Director/Vice President, Medical Lead

Crescent Biopharma , Inc.; Waltham (MA); Vor Ort; USD 330.000 - 365.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Performance bonus

100% employer-paid benefits

Flexible PTO

Professional development resources

Zusammenfassung

A leading biotechnology company in Waltham is seeking a Medical Lead to provide clinical leadership across programs from preclinical to clinical development. The role involves owning medical strategy, leading study design and execution, and maintaining relationships with key stakeholders in the oncology field. Ideal candidates will have an MD and at least 7 years of relevant experience in the life sciences industry. This role offers competitive compensation, comprehensive benefits, and professional development opportunities.

Qualifikationen

• Minimum of 7 years of experience in the life sciences industry, particularly in oncology.
• Proven track record in clinical drug development.
• Strong knowledge of FDA, EMA, ICH-GCP guidelines.

Aufgaben

• Develop and implement the clinical development strategy.
• Lead design and execution of early-phase clinical studies.
• Ensure subject safety and high-quality data collection.

Kenntnisse

Clinical leadership

Oncology expertise

Communication skills

Data interpretation

Relationship-building

Ausbildung

MD or equivalent with clinical training in oncology

Jobbeschreibung

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.

$330,000 - $365,000 a year

Additional Description for Pay Transparency

The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits