Associate Director, Clinical Trial Operations

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.

Position Summary:

The Associate Director, Clinical Trial Operations directs the planning, execution, monitoring, and completion of one or more clinical development programs or projects. The Associate Director interacts with Contract Research Organizations (CROs), external physician investigators, other contracted service providers, and all levels of internal staff, including but not limited to Non-Clinical Development, Clinical Research, Clinical Pharmacology, Biostatistics, Data Management, Clinical Trial Materials Supply, Regulatory, Quality Assurance, Project Management, Finance and Legal.

The Associate Director also serves as a member of the Clinical Operations management team, contributing to departmental policies and SOPs, project, staffing plans, and the like. This role reports to the Director, Clinical Operations.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• In collaboration with internal and external scientific and medical experts, plan and execute clinical trials to support clinical development strategies and plans; participate substantially in the development of a wide variety of critical trial documents, including clinical trial synopses, protocols, case report forms, investigator brochures, and the like; manage internal teams to review and approve clinical study reports in accordance with overall project timelines.
• Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees.
• Lead global clinical studies and provide strategic and tactical planning, organization, direction, and tracking for completing studies within project Timelines.
• Develop request-for-proposals documents and solicit and evaluate bids; lead contracting process with selected CROs, collaborating with relevant departments such as Legal and Finance.
• Manage CROs to execute clinical trials in accordance with contracted scope, costs, and timelines and within budget; actively engage with CROs on defining, monitoring, and reporting on all aspects of key trial performance indicators, including country and site initiation activities, patient screening and randomization rates, and data collection activities.
• Prospectively identify budget, timeline, and quality risks, proactively communicate risks to management team, internal stakeholders and CRO teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete on budget, per specified timelines, and with high-quality data and deliverables.
• Plan and manage project finances in accordance with the Company’s strategic and operating plans and Finance policies.
• Assist in preparation and review of regulatory filings/submissions including protocols, IND/IMPD submission documents and NDA/MAA submissions.
• Lead blinded data review activities in collaboration with data management and other cross-functional team members.
• Write, review, and participate in the preparation of clinical documents (e.g. protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards, Standard Operating Procedures, guidelines and departmental policies).
• Assist in safety monitoring and data management activities.
• Collaborate with the senior management team to ensure consistency across the clinical trial portfolio, as necessary.
• Lead, direct, manage, develop, coach, and evaluate direct reports and other employees in a group in accordance with the Company’s Human Resource policies and plans.
• Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by employees in reporting and other departments.
• Other duties as assigned.

Education and Experience:

Required:

• Minimum BS in biological sciences or related discipline with at least 10 years of related experience. (an equivalent combinat