Senior Director, Drug Product CMC

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. 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:

The Senior Director, Drug Product Development is a highly motivated professional that will perform strategic planning and execution of drug product development and manufacture for its clinical development programs (phase 1, 2, 3), and planned commercial launch, joining its growing and dynamic team. The Senior Director, Drug Product Development provides leadership on all aspects of formulation development and manufacture for the development programs at Crinetics. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company’s effort to discover, develop, and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related-tumors.  This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Plan, direct and oversee all activities related to drug product development, and manufacturing, with emphasis on the manufacture of registration and validation batches for later stage assets

• Develop strategic project and resource plans for company drug development programs, and provide high level guidance to senior management on drug product requirements

• Manage formulation scientists and other skilled professionals and mentoring them in all matters related to drug product development

• Manage priorities and timelines while also creating value by devising new possibilities for IP, incorporating QbD principles when possible and practicing the best/most practical technologies

• Set clear outcomes/deliverables for projects and own them, staying accountable to the CMC team and executive leadership

• Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)

• Budget, manage financials, and forecast all drug product- related expenses (including expenditures with CROs, CDMOs and consultants)

• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers)

• Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations

• Provide presentations and reports progress on multi-disciplinary development teams, as necessary to senior management and BOD

• Develop immediate and short-term (<2 years) strategic planning for function

• Provide mentorship and proactively support the professional development of line reports or colleagues

• Key participant in headcount planning and determine functional/department needs to meet corporate objectives

• Other duties as assigned

Education and Experience:

• Ph.D. in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline with at least 13 years of related technical experience and a minimum of 10 years management experience

• Extensive formulation and process development expertise, with emphasis on small molecule solid oral dosage forms

• Prior experience managing third parties and external service providers (domestic and international), with emphasis of late-phase late phase/commercial contract manufacturing organizations (CROs)

• Demonstrated leadership and management skills, with prior experience managing internal resources

• Manufacturing experience and a good understanding of cGMP requirements

• Understanding of drug substance, solid form science, and analytical chemistry as related to drug product development

• Excellent interpersonal