Executive Director, Regulatory Affairs CMC

About the 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 as single agents and as part of combination regimens to treat a range of solid tumors.

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.
• Provide 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.

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.
• Experience with leading IND and Marketing Applications.
• Experience with antibody drug conjugates and biologics.

Skills

• 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.

Benefits

• 100% employer-paid benefits package (medical, dental, vision, life insurance, short- and long-term disability).
• Company savings plan (401(k)) and long-term incentive program.
• Flexible PTO, plus two one-week company-wide shutdowns each year.
• 10 days sick time per calendar year.
• 16 weeks parental leave within one year of the birth/adoption/foster care of a child.
• Holiday pay, including FMLA and military leave.
• Professional development resources, mentorship, and growth opportunities.

Pay

The salary range for this position is $290,000 to $323,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, and geography.