Associate Director, Clinical Business 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 Associate Director, Clinical Business Operations (AD, CBO) will support the internal growth of the newly formed CBO pillar under the Outsourcing and Vendor Governance (OVG) department.  This role will create processes and infrastructure for CBO, with an initial focus on centralizing investigator site budgets and enhancing the Functional Service Provider (FSP) model for staffing Clinical Operations.  This role will manage day-to-day operations in addition to developing the CBO business unit.  Responsibilities include the development and negotiation of site-specific budgets and contracting and governance with FSPs.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Build and maintain scalable site budgeting infrastructure; subject matter expert (SME) for adoption and utilization of a budget forecasting tool
• Close collaboration with global CRO partners on the site budget template development and negotiation function for Crinetics
• Lead strategic vision, process development and operational oversight of the site budget function
• Develop, negotiate and execute site budgets and ensure consistency among sites with multiple Crinetics’ studies
• Oversee compliance with internal financial policies/SOPs, ICH-GCP compliance, and FMV regulations
• Develop and track site budget metrics to measure performance (e.g., start-up timeline acceleration and negotiated cost savings) and drive process improvement
• Collaborate cross-functionally with Legal, Finance, and Operations

• Develop strategic relationships with FSP providers for Clinical Operations, implementing partnership terms, Key Performance Indicators (KPIs), and governance meetings
• Identify risks and mitigation strategies
• Hire, onboard, train, and manage a CBO team
• Provider leadership and coaching by guiding and mentoring the CBO team to ensure strategic alignment, operational excellence, and continuous improvement
• Support strategic planning initiatives
• Other duties as assigned

Education and Experience:

Required:

• BA/BS in related discipline with at least 10 years of direct clinical business operations experience in a CRO, Biotech or Pharmaceutical organization
• At least 7 years in a management role overseeing individuals in a high performing team environment
• Strong knowledge of clinical trial site budget development, negotiation, and contract management
• Experience with GrantPlan
• Working knowledge of applicable ICH and GCP regulations
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Excellent process development, communication, negotiation, and problem-solving abilities
• Proven history of managing complex projects
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook
• High sense of accountability/urgency

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.

Travel:

You may be required to travel for up to 5% of your time.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer.