Director, ADC & MSAT

About the role

The Director, ADC & MSAT will oversee the management of development, technology transfer, manufacturing, and BLA/launch preparation activities at CDMOs for IDEAYA’s antibody–drug conjugate (ADC) platform and pipeline. This role will be integral to a team executing the CMC strategy to advance ADC programs through clinical development and support global commercial launch and post-approval supply.

Responsibilities

• Manage development, technology transfer, manufacturing, and BLA/launch preparation activities at CDMOs for IDEAYA’s ADC platform and pipeline.
• Collaborate effectively with internal and external subject matter experts to ensure seamless execution of ADC programs.
• Support the development of scalable internal capabilities while operating within a predominantly outsourced manufacturing model.
• Ensure compliance with regulatory requirements and facilitate timely completion of clinical and commercial milestones.
• Oversee the integration of CMC strategies into the overall ADC development plan.
• Work closely with cross-functional teams including R&D, Regulatory Affairs, and Commercial Operations to align CMC strategies with broader business objectives.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, or related field.
• Minimum of 10 years of relevant experience in ADC development, manufacturing, and technology transfer.
• Proven track record of managing complex projects and driving successful clinical and commercial launches.
• Experience in leading teams and providing strategic guidance to cross-functional stakeholders.
• Strong understanding of FDA regulations and guidelines for ADC development and manufacturing.
• Excellent organizational and project management skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Qualifications

• Ph.D. in Chemistry, Biochemistry, Biology, or related field preferred.
• Experience in managing CDMO relationships and ensuring quality control throughout the ADC development process.
• Knowledge of biologics manufacturing processes and regulatory requirements.
• Experience with regulatory submissions and interactions with regulatory authorities.
• Strong communication and interpersonal skills to build and maintain relationships with internal and external partners.

Skills

• Strong technical knowledge of ADC development, manufacturing, and regulatory affairs.
• Experience in leading multidisciplinary teams and driving innovation in CMC strategies.
• Excellent problem-solving and decision-making abilities.
• Ability to manage multiple priorities and deadlines simultaneously.
• Proficiency in Microsoft Office Suite and other relevant software tools.

Benefits

• Competitive salary commensurate with experience.
• Health insurance, dental, and vision plans.
• Paid time off and generous vacation policy.
• Flexible work schedule and remote work options.
• Professional development opportunities and continuing education assistance.
• Employee referral program and wellness initiatives.

Pay

Commensurate with experience.

Schedule

Full-time, four days per week.