Associate Director, Clinical Trial Operations

Associate Director, Clinical Trial Operations

Categories: Clinical 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 polices and SOPs, project, staffing plans, and the like. This role reports to the Director, Clinical Trial 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 combination of experience and education may be considered).

• Minimum of five (5) years of direct clinical study management experience required.

• A minimum of seven (7) prior experience managing others.

• Prior experience managing CROs and other external service providers on a global scale is a must.

• Knowledge of GCPs, ICH guidelines and FDA regulations; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus.

• Prior experience with the preparation of NDAs and MAAs and other regulatory documents is highly desirable.

• Excellent writing skills as they relate to preparation of regulatory documents.

• Excellent interpersonal skills with strong oral/written communication and presentation skills.

• Experience in managing external service providers and consultants.

• Demonstration of a broad-based and cross-functional understanding of the drug development process.

• Excellent time management skills and ability to mentor junior staff in time management.

Preferred:

• Prior experience in the planning and conduct of First in Human and early phase clinical trials.

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.

The Anticipated Base Salary Range: $149,000 - $187,000

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.

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