Senior Manager, Clinical Pharmacology/Bioanalysis Operations

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 Manager, Clinical Pharmacology/Bioanalysis Operations will support the management of outsourced clinical pharmacology, bioanalysis, and biomarker activities. This role will assist in coordinating with the clinical pharmacology and bioanalytical leads and collaborate with cross-functional teams to manage the external service providers and outsourcing needs, including CRO/vendor/consultant evaluation/selection, budget contract negotiation/management, and invoice reconciliation. This individual will also serve as the primary lead for outsourcing dose formulation analysis activities in support of toxicology studies. The work will support projects at various stages of development thereby allowing the individual to play an active role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Generate budget grids/trackers for clin pharm/bioanalytical activities/deliverables for various nonclinical and clinical studies/projects that fulfill the program development plan/goal.
• Assist in coordinating with Finance and Accounting the month-end and budget/forecasting needs, such as accruals, project budgets, etc.
• Liaise with clinical pharmacology and bioanalytical leads and interface with external service providers (CRO/vendor/consultants) to manage contract and invoice process for the outsourced clin pharm/bioanalysis/biomarker analysis activities/deliverables.
• Serve as the primary lead in outsourcing does formulation validation and sample analysis activities in support of toxicology studies.
• Facilitate the negotiation and review final scopes of work, budgets, and payment schedules, with input from the clin pharm/bioanalytical leads.
• Ensure the review invoices against vendor contracts and interface with the clinical pharmacologist/bioanalytical leads to ensure accuracy and satisfactory completion of deliverables.
• Develop and cultivate excellent internal cross-departmental and external service provider relationships to enable advancement of nonclinical and clinical programs.
• Coordinate with Toxicology, CMC, and Clinical Operations to ensure alignment on budgets and timeline for clin pharm/bioanalytical activities/deliverables.
• Work with cross-functional colleagues in various programs to determine assay needs and manage assay selection, sample analysis, and reporting of results in a timeframe consistent with project goals.
• Contract lifecycle management in collaboration with legal department
• In collaboration with centralized outsourcing group, assist in the development, improvement, and implementation of processes and tools related to outsourcing activities.
• Participate in the periodic governance meetings.
  
  

Required

Education and Experience:

• Bachelor’s degree with a minimum of 8 years experience in a relevant scientific field with significant industry experience in a bioanalytical function in CRO, biotech, or pharmaceutical organization
• Must demonstrate an understanding of clin pharm/bioanalytical activities budgets and payment terms with strong scientific and operational background
• Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clin pharm/bioanalytical activities/deliverables.
• Experience in proposal development and evaluation, and contract and budget management.
• Excellent organizational and time management skills, and strong attention to detail, with proven ability to ability to prioritize a diverse workload.
• Thorough understanding of bioanalytical methodologies, GLP/GCP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis.
• Highly knowledgeable on domestic and international service providers.
• Familiarity with all stages of nonclinical and clinical drug development, including prior experience in fit-for-purpose concept in assay development strategy.
• Strong written, presentation and verbal communication skills with an ability to effectively function within a matrixed environment.
• Prior experience in managing central labs would be highly beneficial.
  
  

Preferred

• Experience in preclinical dose formulation validation and analysis
• Experience using project management tools such as Sharepoint and Smartsheet.
• Experience in QC review of bioanalytical content against source data.
  
  

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 5% of your time.

The Anticipated Base Salary Range: $131,000-$163,000

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.

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.

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.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.