Vice President, Regulatory Affairs & Quality (GxP)

4 дн. назад

USADirectorOnsite

regulatory compliancequality management systemsgxpclinical trialsinspection readiness

Lead and oversee integrated Regulatory and Quality function for clinical, manufacturing, and laboratory environments ensuring compliant execution and regulatory strategies.

Обязанности

Develops, owns, and executes Pliant's global regulatory strategy for oncology product candidates across the development lifecycle, from IND/CTA through proof-of-concept and planning for pivotal development.
Leads 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.
Serves as primary agency contact (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.
Advises 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.
Keeps executive leadership apprised of the evolving regulatory landscape affecting oncology development and provides tactical direction to ensure cross-functional consistency in regulatory approach.
Oversees and leads Pliant'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.
Ensures 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.
Oversees a risk-based audit program for CROs, CMOs, clinical sites, and other third-party vendors supporting the oncology pipeline.
Negotiates and manages quality agreements with CMOs, CROs, and other partners and suppliers.
Develops quality system metrics to proactively identify and address potential compliance risks before they affect trial timelines.
Leads quality management and periodic dashboard reviews and ensures no significant disruption to development activities due to quality or compliance issues.
Serves as the key point of contact for managing and directing any regulatory or quality inspections.
Supports the pharmacovigilance and safety functions as an active member of the safety governance and review team, and provides regulatory and quality input into labeling, publications, and investor/legal disclosures related to clinical and nonclinical data, as applicable.
Provides critical evaluation of potential product and partnership opportunities in support of business development and licensing activities.
Owns 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.
Leads, coaches, and develops direct reports, fostering a collaborative, high-performing culture appropriate to the company's stage of growth.
Manages 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.

Требования

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
Bachelor's degree in a scientific field required; advanced degree (e.g., PhD, PharmD, MS) preferred.
15+ years of progressive, relevant experience in Regulatory Affairs and/or Quality within the biotech/pharmaceutical industry, including direct oncology drug development experience.
Minimum of 8+ years of leadership/management experience at a senior level, with direct accountability for team performance and development.
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 and other global health authorities (meetings, inspections, or submissions).
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 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).

Будет плюсом

Experience with small molecule and/or targeted therapy development programs.
Prior experience building or scaling a Regulatory and Quality function to appropriately support a growing clinical-stage company.
Prior experience in an organization transitioning from Phase 1b/2 to late-stage development, including scaling regulatory and quality systems for pivotal trials.
The annual base salary for this role is $351K – $388K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
 
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Другое

At Pliant, we believe differentiated science can make a meaningful impact. We see our success as a direct result of the central role that each team member plays in advancing our mission to develop therapies that target the disease at its source. We are seeking creative, curious and collaborative individuals who  dare to succeed , are committed to  making an important impact  on patient’s lives and will help us build  one Pliant !
Reporting to the Chief Operating Officer, the Vice President, Regulatory Affairs & Quality (GxP) will lead and oversee an integrated Regulatory and Quality function for our portfolio of programs, including our lead oncology program currently in Phase 1b. This is a hands-on role for a leader who will own day-to-day global regulatory and quality strategies and execution, and also oversee a Quality team and its deliverables. The successful candidate will design and scale right-sized regulatory and quality infrastructure in GxP environments (including and not limited to clinical, manufacturing, and laboratories) that supports rapid, compliant execution of early phase clinical trials, while laying the foundation for later-stage and eventual commercial readiness, as appropriate.
This individual will serve as Pliant's primary interface with the FDA and other global health authorities for both regulatory strategy and inspection readiness, and will be accountable for ensuring the company's portfolio pipeline is developed in full compliance with applicable regulations while maintaining the speed and flexibility required of a clinical-stage biotech.
This is a hybrid position, 3 days/week onsite (South San Francisco).