Vice President Regulatory Affairs & Quality

This clinical-stage biopharmaceutical company is a leader in the development of integrin-based therapeutics for the treatment of cancer and other diseases. They are seeking a VP of Regulatory and Quality to lead their integrated Regulatory and Quality function for their portfolio of clinical and pre-clinical programs. Reporting into the COO, this individual will own day-to-day global regulatory and quality strategies and execution, while serving as the primary interface with health authorities. This company offers a science-based, passionate company culture and hybrid work arrangements.

Responsibilities:

• Develop, own, and execute global regulatory strategy for oncology product candidates across the development lifecycle, from IND/CTA through proof-of-concept and planning for pivotal development.
• Lead the day-to-day preparation, review, and submission of regulatory filings - including INDs/CTAs, protocols, and briefing documents - partnering closely with clinical development, CMC, biometrics, and translational teams.
• Serve as primary agency contact (with FDA and other health authorities) for regulatory interactions, including pre-IND, End-of-Phase 1/2, and other milestone meetings, fostering strong relationships and acting as a credible, effective advocate for the company.
• Advise the executive team on oncology-specific regulatory pathways and designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, Accelerated Approval) and their strategic implications for trial design and sequencing.
• Keep executive leadership apprised of the evolving regulatory landscape affecting oncology development and provides tactical direction to ensure cross-functional consistency in regulatory approach.
• Oversee and lead the company’s Quality team, providing strategic direction and management of an integrated, risk-based Quality Management System (QMS) covering GLP, GCP, GVP and GMP appropriate to a Phase 1/2 development-stage organization.
• Ensure quality policies, procedures, and a lean, fit-for-purpose suite of SOPs are in place, understood, and consistently followed to support IND-enabling studies, clinical trial conduct, and investigational product manufacturing and release.
• Oversee a risk-based audit program for CROs, CMOs, clinical sites, and other third-party vendors supporting the oncology pipeline.
• Negotiate and manage quality agreements with CMOs, CROs, and other partners and suppliers.
• Develop quality system metrics to proactively identify and address potential compliance risks before they affect trial timelines.
• Lead quality management and periodic dashboard reviews and ensure no significant disruption to development activities due to quality or compliance issues.
• Serve as the key point of contact for managing and directing any regulatory or quality inspections.
• Support the pharmacovigilance and safety functions as an active member of the safety governance and review team, and provide regulatory and quality input into labeling, publications, and investor/legal disclosures related to clinical and nonclinical data, as applicable.
• Provide critical evaluation of potential product and partnership opportunities in support of business development and licensing activities.
• Own departmental planning for the combined Regulatory and Quality organization - including structure, headcount, budgeting, and systems requirements - scaling in step with pipeline maturity and organizational growth.
• Lead, coach, and develop direct reports, fostering a collaborative, high-performing culture appropriate to the company’s stage of growth.
• Manage relationships with external consultants and other third-party service providers (i.e. CROs), including determining when and how to engage outside support as the organization scales.

Qualifications:

• Bachelor’s degree in a scientific field required. Advanced degree in life sciences, pharmacy, chemistry, or related field (eg. MS, PharmD, or PhD) preferred.
• 15+ years of progressive, relevant experience in Regulatory Affairs within the biotech/pharmaceutical industry.
• Must have strong experience with oncology drug development (10 or more years).
• Must have experience working across all phases of development from pre-IND to post approval.
• Experience with small molecule immuno-oncology programs and/or targeted therapy development programs highly desired.
• Minimum of 8+ years of leadership/management experience at a senior level, with direct accountability for team performance and development.
• Prior experience building or scaling a Regulatory and Quality function to appropriately support a growing clinical-stage company.
• Demonstrated experience leading (not solely overseeing) the preparation and submission of INDs/CTAs and other regulatory filings, with direct ownership of regulatory strategy for early-phase oncology assets (Phase 1/1b/2), including dose-escalation and expansion trial designs.
• Direct, hands‑on experience serving as primary agency contact and leading interactions with FDA’s oncology divisions and other global health authorities.
• Prior experience in an organization transitioning from Phase 1b/2 to late-stage development, including scaling regulatory and quality systems for pivotal trials.
• Experience leading marketing applications (NDA/BLA/MAA) with successful drug approvals highly desired.
• Strong knowledge of the GXP environment required. Experience overseeing Quality Assurance a plus.
• Working knowledge of GLP, GCP, GVP and GMP requirements and practical experience implementing FDA and international (EMA or equivalent) regulations and guidance in a development-stage environment.
• Experience with oncology‑specific regulatory designations and expedited pathways (Fast Track, Breakthrough Therapy, Orphan Drug, Accelerated Approval).
• Experience developing creative regulatory strategies to advance programs through the pipeline.
• Experience managing relationships with CROs and CMOs, including audits, quality agreements, and vendor oversight.
• Proven ability to operate as both strategic advisor to the executive team and hands‑on practitioner, given the lean team structure typical of a Phase 1/2 company.
• Excellent written and verbal communication skills across all levels of the organization and with external partners.
• Ability to travel as needed (approximately 15-20% of time).
• Must be comfortable with ambiguity in a small biotech environment.

This is a hybrid position in the San Francisco Bay Area (3 days per week). NOTE: Our client prefers local candidates in the SF Bay Area or those elsewhere on the West Coast who are willing to travel regularly.

The budgeted salary range for this position is $351,000 to $388,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.