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Crescent Biopharma

Clinical-stage biotech developing solid-tumor therapies

Executive Director - Regulatory Affairs CMC

Full-Time
No salary listed
Expert
Bachelor's, Master's, PhD
Waltham, MA, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • 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
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

About the company

Crescent Biopharma develops oncology therapies for solid tumors, focusing on immuno-oncology and targeted approaches. Its lead program, CR-001, is a tetravalent antibody that blocks PD-1 and VEGF to boost anti-tumor immunity while cutting blood vessel growth, and it is in a global Phase 1/2 trial. Additional programs include CR-002, an anti-PD-L1 antibody-drug conjugate, and CR-003, an ITGB6-targeted ADC, creating a multi-modal portfolio. The company differentiates itself by pursuing combination strategies that pair immune checkpoint blockade with VEGF inhibition and other targeted modalities, and its goal is to advance multi-agent regimens for solid tumors toward regulatory approval and commercialization.

Company Size

51-200

Company Stage

IPO

Headquarters

Waltham, Massachusetts

Founded

2003

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Simplify's Take

What believers are saying

  • July 30, 2026 funding lifted pro forma cash to $305.1 million.
  • ASCEND enrollment progressed in 2026, with first patient dosed February 18, 2026.
  • CR-002 IND submission and first combination trials are scheduled for H2 2026.

What critics are saying

  • CR-001 trails ivonescimab, which beat pembrolizumab in Phase III during 2025-2026.
  • ASCEND's first meaningful readout arrives Q1 2027; failure would crush CBIO's thesis.
  • Three raises since June 2025 signal relentless dilution if trials miss or slow.

What makes Crescent Biopharma unique

  • CR-001 pairs PD-1 and VEGF blockade, targeting a crowded solid-tumor backbone.
  • Kelun-Biotech partnership gives Crescent ex-China rights to SKB105 and China rights to CR-001.
  • June 2025 merger transformed a dead-listing into a cash-rich oncology platform.

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Benefits

Unlimited Paid Time Off

Flexible Work Hours

Remote Work Options

Hybrid Work Options

Parental Leave

401(k) Retirement Plan

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Professional Development Budget

Growth & Insights and Company News

Headcount

6 month growth

2%

1 year growth

1%

2 year growth

16%
AllSci
Jul 15th, 2026
Crescent Bio to raise USD 125m to provide oncology pipeline runway into 2028.

Crescent Bio to raise USD 125m to provide oncology pipeline runway into 2028. July 15, 2026 Massachusetts-based Crescent Biopharma, Inc. (Nasdaq: CBIO) announced the pricing of an underwritten public offering of ordinary shares and pre-funded warrants, raising approximately USD 125 million in gross proceeds to fund the clinical advancement of its oncology pipeline, including its lead PD-1 x VEGF bispecific antibody and two ADC programs. The raise extends the company's cash runway, which stood at USD 189 million as of March 31, 2026 and was projected to fund operations into 2028 - a figure that the current offering materially supplements ahead of multiple anticipated data readouts in 2027. The offering comprises 8,094,793 ordinary shares priced at USD 14.50 per share, with pre-funded warrants to purchase up to 525,897 additional shares offered at USD 14.499 per warrant to certain investors in lieu of ordinary shares. Underwriters were granted a 30-day option to purchase up to an additional 1,293,103 ordinary shares at the offering price, which if exercised in full would increase total gross proceeds beyond the USD 125 million base. The offering was expected to close on July 16, 2026. Crescent's pipeline is built around three clinical or near-clinical assets, all developed in partnership with China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. under a bilateral licensing arrangement announced in December 2025 that included an USD 80 million upfront payment by Crescent for ex-China rights to CR-003 and a reciprocal grant to Kelun-Biotech of Greater China rights to CR-001. The lead asset is CR-001, a tetravalent bispecific antibody simultaneously blocking PD-1 and VEGF, currently being evaluated in the global Phase I/II ASCEND trial across multiple solid tumor types including non-small cell lung cancer and gastrointestinal and gynecological cancers. First patient dosing occurred in February 2026. Management has guided for proof-of-concept data - covering initial safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity - in Q1 2027, with combination data alongside standard-of-care chemotherapy expected by mid-2027. The first ADC combination trial pairing CR-001 with a Kelun-Biotech ADC is on track to initiate in H2 2026. CR-001 operates in a competitive space alongside ivonescimab, which demonstrated superiority over pembrolizumab in a large Phase III trial, though cross-trial comparisons remain constrained by differences in design and patient populations. CR-002, a PD-L1-targeted ADC with a topoisomerase I inhibitor payload, is on track for IND submission to the US FDA in mid-2026, with Phase I/II trial initiation planned for H2 2026 and proof-of-concept data anticipated in H2 2027. CR-003, an ITGB6-targeted ADC also carrying a topoisomerase I payload, is already in an ongoing Phase I/II trial in China under Kelun-Biotech's sponsorship, with proof-of-concept data expected in Q1 2027. A Phase I/II combination trial of CR-003 and CR-001 is expected to initiate in H1 2027. The current offering is Crescent's third significant capital raise since its June 2025 Nasdaq debut via reverse merger with GlycoMimetics, which was accompanied by a concurrent USD 200 million private placement. A second USD 185 million private placement closed in December 2025 alongside the Kelun-Biotech partnership. The July 2026 public offering represents a shift from institutional private rounds to a broader public equity raise, providing additional capital flexibility as the company approaches its first clinical data milestones. Q1 2026 net loss was USD 23.3 million on R\&D expenses of USD 17.9 million, reflecting accelerating clinical spend as ASCEND enrollment advances and IND preparations for CR-002 proceed. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/

Aktiencheck.de AG
Jul 14th, 2026
Crescent Biopharma launches public offering of ordinary shares and pre-funded warrants

Crescent Biopharma, a clinical-stage biotechnology company focused on cancer therapies, announced it has launched an underwritten public offering of ordinary shares and pre-funded warrants. The Waltham, Massachusetts-based company plans to grant underwriters a 30-day option to purchase up to an additional 15% of ordinary shares at the public offering price, less underwriting discounts and commissions. All securities in the proposed offering will be sold by Crescent. The offering is subject to market and other conditions, with no assurance regarding completion timing or final size and terms.

GlobeNewswire
Jul 14th, 2026
Crescent Biopharma Announces Proposed Public Offering of Ordinary Shares and Pre-Funded Warrants

WALTHAM, Mass., July 14, 2026 (GLOBE NEWSWIRE) -- Crescent Biopharma, Inc. (“Crescent” or the “Company”) (Nasdaq: CBIO), a clinical-stage biotechnology...

Business Wire
Jun 27th, 2026
GlycoMimetics Enters Into Acquisition Agreement With Crescent Biopharma

GlycoMimetics, Inc. (NASDAQ: GLYC) announced today it has entered into an acquisition agreement with Crescent Biopharma, Inc. (“Crescent”), a privately held ...

AD HOC NEWS
Feb 7th, 2026
Fidelity takes 15% stake in Crescent Biopharma ahead of key industry summit

Fidelity has taken a 15% stake in Crescent Biopharma, accumulating approximately 4.13 million shares as of year-end, according to regulatory filings. The investment from one of the world's largest asset managers signals institutional confidence in the biotech company's strategic direction. The stake disclosure comes ahead of Crescent's appearance at the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on 12 February. The company's executive team will participate in a fireside chat at 11:30 EDT, with a live webcast available for remote viewers. Crescent shares closed at $9.51 on Thursday, down 3.09%, but trading volume of 510,788 shares significantly exceeded the 20-day average of 198,000, suggesting investors are positioning ahead of the conference presentation.