---
title: 'Executive Director, Regulatory Affairs CMC at Crescent Biopharma'
canonical: 'https://feeny.ai/job/executive-director-regulatory-affairs-cmc-crescent-biopharma-waltham-m0e9ryfqjqmg'
type: 'job'
last_seen: '2026-09-10'
---

# Executive Director, Regulatory Affairs CMC at Crescent Biopharma

- **Company:** Crescent Biopharma
- **Location:** Waltham, MA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-05-29
- **Last confirmed live:** 2026-09-10
- **Apply:** https://jobs.lever.co/crescent-biopharma/4fe576ee-53b8-4ab8-b26a-d61b7964734b

## Job description

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 as single agents and 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.

## Responsibilities

- Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product lifecycle.
- Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as needed
- Provide strategic regulatory guidance to TechOps and Quality organizations to ensure global compliance and readiness for clinical and commercial supply
- Serve as the primary interface with global regulatory agencies for CMC-related negotiations, milestone meetings, and information requests.
- Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
- Manage junior team members and contractors to support development activities

Education & Experience

- BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required
- 12 years’ experience in Regulatory Affairs CMC in Pharma/Biotech
- Strong negotiation skills with health authorities (e.g.  FDA, EMA) as well as submissions
- Experience with leading IND and Marketing Applications
- Experience with antibody drug conjugates and biologics
- Strong analytical, strategic thinking, and problem-solving skills.
- Excellent communication and leadership abilities; able to influence across all levels of the organization.
- Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities.
- Commitment to fostering a diverse and inclusive workplace

## 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; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities

Salary Range

The salary range for this position is $290,000 to $323,000. 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.

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](https://nam13.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.crescentbiopharma.com%2Fcareers%2F%23benefits&data=05%7C02%7Clee.schwartz%40crescentbiopharma.com%7Ca470e7b902eb4129a1a808de166a540b%7Cea3ae1e37f5f46159580d5c6e0711b3c%7C0%7C0%7C638972843088266995%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wT1Z9wts792%2FEuLYQJs2HxHxehSvTRx7cAguiMD4XY0%3D&reserved=0)

Please note: Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

## #LI-CBIO

## About Crescent Biopharma

## Company Overview
- **One-liner**: Crescent Biopharma is a clinical-stage oncology company developing next-wave cancer therapies, including a PD-1 x VEGF bispecific antibody and antibody-drug conjugates (ADCs) for solid tumors.
- **Entity Type**: Public (IPO in June 2025; ticker not disclosed in available data)
- **Headquarters**: Waltham, Massachusetts, United States (300 Fifth Avenue, Waltham, MA 02451)
- **Founded**: Year not publicly available (company appears to have been active before 2024; IPO in 2025)
- **Founders**: Not publicly available (leadership includes CEO Joshua Brumm, but founder information is not listed)

## Core Business
- **Primary industry/industries**: Oncology biotechnology / Therapeutics
- **Target customers**: B2B – primarily focuses on developing and commercializing cancer therapies, with partnerships and collaborations (e.g., Kelun-Biotech, Paragon Therapeutics)
- **Mission or purpose statement**: “Delivering the next wave of transformative therapies to bring a brighter future for people living with cancer.”

## Products & Services
- **CR-001 (PD-1 x VEGF bispecific antibody)**: A tetravalent bispecific antibody in Phase 1/2 clinical trials (ASCEND) for advanced solid tumors. Designed to exhibit cooperative pharmacology similar to ivonescimab; aims to restore T-cell activity and localize anti-VEGF activity in the tumor microenvironment. Collaboration with Kelun-Biotech for Greater China rights.
- **CR-002 (PD-L1–directed ADC)**: A topoisomerase inhibitor ADC targeting PD-L1, with high internalization. IND planned for mid-2026, with Phase 1/2 trial expected in H2 2026.
- **CR-003 (ITGB6–directed ADC)**: A differentiated ADC targeting integrin beta-6 (ITGB6), with a topoisomerase 1 inhibitor payload. Uses Kthiol conjugation technology. Licensed from Kelun-Biotech for ex-Greater China markets; Phase 1/2 trial ongoing in China.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (public company as of 2025, but no valuation or market cap figure available in provided data)
- **Key Metric**: Total Funding: $585M (including $200M Series A in 2024, $185M Post-IPO Equity in 2025, and $200M Post-IPO Equity in 2025 led by Fairmount Funds Management)
- **Notable Investors/Partners**: Fairmount Funds Management, Venrock Healthcare Capital Partners, Kelun-Biotech (strategic collaboration), Paragon Therapeutics
- **Growth Signals**: Headcount grew 129.6% YoY to 55 employees (LinkedIn); IPO in June 2025; multiple pipeline programs advancing toward IND; expansion into ADC combination trials

## Competitive Advantages
- Focus on established, clinically validated targets (PD-1, VEGF, PD-L1, ITGB6) to reduce risk and accelerate development
- Multi-modality approach (bispecific antibodies + ADCs) enabling combination therapies with potential synergistic effects
- Proprietary ADC technology (Kthiol conjugation) and strategic collaborations for global rights to differentiated assets
- Strong leadership team with deep oncology drug development expertise (former executives from major biopharma)

## Strategic Focus
- Advance CR-001 as a foundational backbone therapy, with initiation of combination trials with ADCs in H2 2026
- Submit IND for CR-002 in mid-2026 and begin Phase 1/2 trials
- Progress CR-003 clinical program and explore additional internal and partnered ADC and immuno-oncology opportunities
- Build a leading oncology company through disciplined execution, leveraging established biology and multiple modalities

## Why Work Here
- **Culture highlights**: “No egos, collaborative spirit,” “roll up sleeves,” “move with urgency,” “data-driven science with patients as true north.” Emphasizes transparency, integrity, and impact.
- **Remote/hybrid/office policy**: Not explicitly stated; headquarters in Waltham, MA, with an office in Rockville, MD. Likely requires on-site presence given the “highly collaborative” and “urgent” culture.
- **Notable perks**: 100% employer-paid medical, dental, vision, short/long-term disability, life insurance; HSA and dependent care FSA; 401(k); subsidized lunch program; flexible vacation and paid holidays including summer and year-end office closures (one week each).
- **Best for**: Bold innovators who want to make a significant impact in oncology drug development, thrive in a fast-paced, transparent environment, and are motivated by patient outcomes.

## Sources
1. [crescentbiopharma.com – Careers](https://www.crescentbiopharma.com/careers/)
2. [crescentbiopharma.com – About](https://www.crescentbiopharma.com/about/)
3. [crescentbiopharma.com – Pipeline](https://www.crescentbiopharma.com/pipeline/)
4. [linkedin.com – Crescent Biopharma](https://www.linkedin.com/company/crescent-biopharma)
5. [jobs.lever.co – Crescent Biopharma](https://jobs.lever.co/crescent-biopharma)

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