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About the Role

IDEAYA is a precision medicine oncology company dedicated to discovering, developing, and commercializing transformative cancer therapies. We integrate expertise in small-molecule drug discovery, structural biology, and bioinformatics with internal capabilities in identifying and validating translational biomarkers to develop targeted therapies. Our mission is to deliver next-generation precision oncology treatments that are more selective, effective, and personalized, aiming to significantly improve patient outcomes. At IDEAYA, you will collaborate with brilliant minds passionate about advancing precision medicine.

Responsibilities

Lead formulation efforts and manage multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial).
Author and review technical development reports, batch records, campaign reports, change controls, CAPAs, deviations, and investigations.
Author and review technical sections in IND/IMPD/NDA for global CMC regulatory submissions and stay current on Health Authority guidance.
Develop DP strategies to meet program targets, ensure timely delivery of high-quality products, and facilitate regulatory approvals.
Represent DP/CMC and participate in cross-functional project teams, managing multiple priorities in a fast-paced environment.
Provide quick problem-solving to ensure on-time drug supply for PK/PD, efficacy, DRF, pilot toxicology studies, IND-enabling activities, and clinical trials.
Collaborate with cross-functional teams including Medicinal Chemistry, DMPK, Analytical Chemistry, Process Chemistry, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology.
Proactively communicate and align DP and CMC strategies with other functions to meet aggressive timelines.
Lead dosage form selection, formulation development, process optimization, and scale-up activities.
Ensure robust, cost-effective, and scalable manufacturing processes.
Lead the evaluation, selection, and management of CDMOs for formulation and process development, and GMP manufacturing.
Oversee technology transfer activities at CDMOs and provide technical expertise for troubleshooting.
Act with integrity, comply with laws and policies, demonstrate good judgment, prioritize patient and product safety, and report suspected violations.

Requirements

Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering, or related discipline with a minimum of 12 years of development experience and demonstrated ability in leading cross-functional groups, OR M.S. with a minimum of 15 years of development experience.
Late phase and commercial experience are a plus.
Demonstrated track record of success in delivering timely execution of DP and CMC activities from preclinical to commercialization.
Demonstrated expertise in small molecule formulation development (traditional oral solid dosage and enabling formulations like ASD and HME are a plus), scale-up, and manufacturing.
Experience with phase-appropriate control strategy and specification development.
Experience with analytical techniques for small molecules and oral solid dose products, including proficiency in UPLC/HPLC, dissolution, and solid-state characterization (DSC/TGA, PLM, XRPD, PSD).
Ability to interpret analytical data and apply it to formulation development.
Strong understanding of physico-chemical properties of API, PK/PD correlation, and phase-appropriate formulation development.
Strong understanding of Quality systems including SOPs, manufacturing record review, batch release, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance (ICH, FDA, MHRA, EMA; USP-NF, Ph. Eur, BP, JP).
Experience managing global CDMOs, reviewing documentation, and ensuring guideline adherence.
Exceptional problem-solving skills and adaptability.
Excellent interpersonal and communication skills for internal and external collaborations.
Ability to multi-task in a fast-paced dynamic environment with a calm and positive attitude.
Superior work ethic.
Excellent interpersonal communication and decision-making skills.
Ability to travel domestically and internationally to oversee DP development and manufacturing at CDMOs.

Skills

Formulation Development
CMC
Drug Development
CDMO Management
Regulatory Submissions (IND/IMPD/NDA)
CMC Regulatory
Small Molecule Formulation
Oral Solid Dosage Forms
Amorphous Solid Dispersions (ASD)
Hot Melt Extrusion (HME)
Process Optimization
Scale-up
Manufacturing
Technology Transfer
Analytical Techniques (UPLC/HPLC, Dissolution, DSC/TGA, PLM, XRPD, PSD)
Quality Systems
cGMP
ICH Guidelines
FDA Guidelines
MHRA Guidelines
EMA Guidelines
USP-NF
Ph. Eur
BP
JP
Problem-Solving
Communication
Interpersonal Skills
Collaboration
Project Management

Location

South San Francisco, CA

Work Type

Onsite (four days per week)
Hybrid

Experience Level

Director
Minimum 12 years (Ph.D.) or 15 years (M.S.) of development experience
Late phase and commercial experience are a plus

Education Level

Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering, or related discipline
M.S. in Pharmaceutics, Chemistry, Chemical Engineering, or related discipline

Salary/Compensations

$215,000 - $266,000

Benefits

Competitive total rewards package
Merit-based salary increases
Company discretionary short-term incentive plan participation
Company discretionary stock option awards
Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
401k
ESPP
Wellness programs

About the Company

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.
Company Values: Passionate Commitment, Fearless Innovation, Courageous Integrity, Respectful Teamwork, Objective Decision-Making, Empowered Accountability.

Equal Opportunity

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.
IDEAYA is an equal opportunity employer.
In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.
EOE/AA/Vets.
We are committed to providing reasonable accommodations to qualified individuals with disabilities.
If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.