Associate Director, Drug Product Development
About The Position
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: This position will report to the Senior Director of Drug Product Development and will be managing the activities related to preformulation, biopharmaceutics, formulation development from Phase 1 to commercial launch. This individual will be an integral part of the company’s effort to discover and develop therapeutics for rare endocrine disorders and endocrine-related tumors.
Requirements
- A PhD in Pharmacokinetics, Pharmaceutical Science, or a related field with at least 7 years of related technical experience in the small molecule biopharmaceutical industry.
- Experience supporting regulatory submissions with biopharmaceutics expertise.
- Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp.
- Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions.
- Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization.
- Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling.
- Lead work experience in drug product development and clinical manufacturing for small molecules.
- Excellent analytical, problem-solving, and communication skills.
Nice To Haves
- Understanding of cGMP requirements and ICH and regulatory guidance is preferred.
Responsibilities
- Integrate biopharmaceutics principles to guide drug product design and development, ensuring clinically meaningful formulation strategies.
- Design and develop formulation and processes to enable clinical studies with the desired performance.
- In collaboration with DMPK and Clinical Pharmacology, develop and apply advanced modeling-informed strategies (e.g., PBPK) to predict drug dissolution, absorption, bioavailability, enabling formulation optimization, bridging decisions, and risk mitigation.
- Design and execute experiments for development of rational, scientifically sound, phase appropriate formulations and manufacturing processes including biorelevant conditions to simulate in vivo performance.
- Utilize software tools such as GastroPlus to model gastrointestinal physiology and inform formulation decisions.
- Apply deep understanding of physiological factors (e.g., GI pH, transit times, regional absorption) to interpret human and animal clinical data, linking dissolution behavior to in vivo drug performance and guiding formulation refinement.
- Contribute biopharmaceutics expertise to regulatory submissions, including IVIVC (In Vitro–In Vivo Correlation) and MIDD (Model-Informed Drug Development).
- Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements.
- Plan, direct, and oversee formulation, process development, manufacturing, and packaging activities at contract development and manufacturing organizations (CMOs).
- Evaluate and select external partners for drug product development and manufacturing.
- Prepare Drug Product development and manufacturing timelines and set clear deliverables for projects
- Prepare and review request of proposal (RFPs), statements of work (SOWs), and associated budgets.
- Prepare and review regulatory filings (IBs, INDs, IMPDs, NDAs, briefing packages).
- Author and review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure compliance with cGMP and company standards.
Benefits
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
- top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- winter company shutdown
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
251-500 employees
