Vice President, Antibody Drug Conjugate (ADC) Development and Manufacturing

IDEAYA Biosciences•South San Francisco, CA

27d•$300,000 - $370,000•Hybrid

About The Position

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. We are seeking a Vice President, ADC Development & Manufacturing to join IDEAYA’s Chemistry Manufacturing Controls (CMC) team. The Vice President, ADC Development & Manufacturing, will have end-to-end responsibility for the development, manufacturing, and lifecycle management of IDEAYA’s antibody–drug conjugate (ADC) platform and pipeline, spanning early development, clinical supply, and commercial manufacturing. This role will define and execute the CMC strategy required to advance ADC programs through clinical development and successfully enable global commercial launch and post-approval supply. This position requires a senior CMC leader with technical experience in antibody/ADC development, providing leadership to internal and external subject matter experts. The candidate has strong execution capability across clinical and commercial stages, and experience operating within a predominantly outsourced manufacturing model while building scalable internal capabilities. This role reports to the Head of CMC and is based in IDEAYA’s South San Francisco, California office, with an expectation to be in the office 4 days a week.

Requirements

PhD in Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline (or equivalent experience).
15+ years of experience in biologics and/or ADC development and manufacturing, with significant experience supporting early to late-stage clinical development and commercial manufacturing.
Demonstrated success advancing ADCs through Phase 3 and into commercial supply.
Extensive experience managing CDMOs and global CMC programs.
Technical expertise in ADC technologies, including USP/DSP of antibody production, conjugation, analytical characterization, and process validation.
Strong working knowledge of global regulatory requirements for biologics and ADCs.
Experience supporting BLA/MAA submissions and regulatory inspections.
Proven executive leadership with strong cross-functional influence.
Strategic, decisive, and execution oriented.
Excellent communication skills with the ability to translate technical complexity into business impact.
Direct experience launching or supporting a commercial ADC product.
Experience scaling manufacturing and supply chains for oncology biologics.
All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels
This position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Responsibilities

Ensure seamless progression of ADC programs across clinical phases and into commercial manufacturing, with a clear long-term supply vision.
Serve as the CMC accountable leader for ADC programs at governance and portfolio review forums.
Lead CMC execution to support Phase 1–3 clinical development, including clinical supply planning, process evolution, and change management.
Ensure timely, compliant manufacture of ADC drug substance, drug product, and conjugation intermediates to meet clinical demand.
Drive phase-appropriate control, comparability, and stability strategies to enable efficient clinical progression.
Establish and execute commercial manufacturing strategies, including process validation, PPQ, and commercial control strategies.
Lead preparation and execution of late-stage CMC activities supporting BLA/MAA submissions and global launches.
Own post-approval lifecycle management, including process optimization, site changes, scale expansion, and regulatory variations.
Oversee ADC process development, scale-up, and technology transfer for antibody, linker–payload, conjugation, and drug product.
Define analytical development and characterization strategies supporting clinical and commercial requirements.
Ensure robust, regulatory-compliant control strategies addressing ADC-specific CQAs across the product lifecycle.
Lead selection, qualification, and governance of CDMOs supporting clinical and commercial manufacturing.
Ensure external manufacturing networks are inspection-ready and capable of supporting global supply.
Manage cost, capacity, and risk across the ADC supply chain.
Provide CMC leadership for IND/CTA and BLA/MAA submissions and health authority interactions.
Partner with Quality to ensure GMP compliance, inspection readiness, and continuous improvement.
Support regulatory responses, inspections, and post-approval commitments related to ADC CMC.
Build, lead, and develop a high-performing ADC CMC organization capable of supporting clinical development and commercial operations.
Balance internal expertise with strategic use of external partners.
Foster a culture of accountability, scientific excellence, and cross-functional collaboration.