Senior Director, Clinical Trial Supplies en Crinetics

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:

The Senior Director, Clinical Trial Supplies, is an end-to end clinical supply planning leader that provides relevant expertise in a fast paced biotech environment. This individual will perform strategic, clinical supply management for its clinical development programs (phase 1, 2, 3) and support commercial launch, and will report to the SVP, Technical Operations.

The Senior Director works internally with other members of Global Supply Chain (GSC) and other Crinetics functions – e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create a competitive advantage.  This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. The individual has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.

The individual will also have strong, cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. The Technical Operations team is highly collaborative with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams  especially for complex development programs - e.g., late phase, acquisition, partnership/alliance, new modality, etc.).

• Lead the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials and domestic trials.

• Oversee and support clinical study planners in a matrix environment. Facilitate issue and risk identification, mitigation, resolution and communication.

• Drive decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.

• Identify, manage and mitigate supply risks at clinical development program level. Lead and drive visible, impactful process improvements and change business and organizational imperatives.

• Author, revise, and review standard operating procedures (SOPs), work instructions, and business policies.

• Manage clinical supply budget of assigned clinical development program(s).

• Review and approve statements of work, purchase orders, and invoices.

• Influence (and at times drive) program allocations at partners, including contract manufacturing organizations (CMOs).

• Oversee contract packaging and distribution vendor operations for Crinetics’ sponsored ongoing and upcoming clinical trials, including budget, timelines, review of specifications, master and executed packaging records, labeling, distribution instructions, logistics, and QP interactions.

• Ensure timely execution of domestic and international distribution of Clinical Trial Materials for all therapeutic programs. Plan appropriate inventory at warehouse and site levels and monitor drug supply usage, use date expiry, drug returns, field transfers, and destruction.

• Forecast demands for clinical supplies and coordinate production and shelf-life extension with the Drug Product and Analytical team.

• Select, implement, and manage IRT systems from set up to close out with Data Management and Clinical Operations.

• Create and manage a global team of skilled professionals, mentoring them in all matters related to clinical supplies.

• Develop strategic project and resource plans for company clinical supplies, setting clear outcomes and deliverables, and provide high level guidance to senior management on drug supply requirements.

• Build and maintain a network of CROs, CDMOs, and packaging and distribution facilities appropriate to each phase of development.

• Establish supply chain strategy for commercially available comparators, rescue medications, ancillary medications, etc. to support domestic and international clinical trials.

• Integrate and influence cross-functional internal and external teams across Technical Operations, Clinical Operations, Regulatory Affairs, and Quality Assurance to deliver clinical trial materials fit for their intended use and in compliance with local compliance and regulatory standards.

• Review global clinical labels, pharmacy manuals, and clinical supplies Standard Operating Procedures.

• Manage the scope, cost, timelines, and quality of integrated clinical trial supplies plans.

• Contribute to preparation of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).

• Support Quality Assurance with implementation and management of the quality system and compliance activities, including inspections by regulatory agencies and audit functions.

• Other duties as assigned.

Education and Experience:

Required:

• A bachelor’s degree in in life sciences, engineering, business, or relevant discipline with at least 15 years of related technical experience (or a master’s degree with at least 13 years of related technical experience) in the pharmaceutical industry with increasing responsibility in clinical supplies management, plus a minimum of 10 years in a supervisory role.

• Previous experience in rare diseases/oral solid dosage forms is a plus.

• Prior experience building a global clinical supplies organization is highly desirable.

• Import and export management of drug substance and drug product, including selection of importer of record and familiarity with VAT strategies.

• Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.

• Demonstrated ability to collaborate in a cross-functional environment.

• Strong experience in project management best practices.

• Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners and training material to investigators/site personnel.

• Experience with preparation of regulatory documents is desired.

• Excellent ability to work in a goal and team-oriented setting and to handle competing priorities.

• Flexibility within a rapidly changing environment and high attention to details.

• Well-developed organizational skills and the ability to thrive under pressure.

• Well-versed in industry trends, emerging business processes and technologies.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 20% of your time.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Total Compensation:

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.