Director, Clinical Monitoring

Director, Clinical Monitoring

Categories: Clinical 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. 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 Director, Clinical Monitoring is responsible for talent hiring, development, and performance management of Clinical Monitoring staff to ensure conduct of activities is compliant with regulatory requirements, GCP, and Crinetics SOPs. The Director will be accountable for execution of all monitoring and site management activities including onsite and remote visits, investigational product accountability and management, patient recruitment, investigator site file review and reconciliation, and delivery of quality data. The Director is also responsible for strategic development of Clinical Monitoring function including creation of processes and tools/templates to optimize monitoring productivity and ensure the quality and efficient delivery of the Crinetics portfolio.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide leadership support to clinical study teams and/or Clinical Monitoring Managers with study execution and oversight related to Clinical Monitoring, such as monitoring plans and visit planning. Support team with identification and communication of monitoring risks and proposed mitigations.

• Lead team in building strong relationships with Principal investigators, site staff, and vendors.

• Ensure Clinical Monitoring Managers develop, maintain and act on metrics related to Monitoring and CRA performance as well as site performance.

• Lead the development of Clinical Monitoring procedures and tools/templates for increased efficiency and quality of deliverables. Develop SOPs, WIs, and other procedural documents.

• Management and leadership of Clinical Monitoring Managers and if needed, assigned Crinetics and FSP CRAs responsible for Clinical Monitoring activities.

• Oversight to ensure adequate resourcing for all CRAs and Clinical Monitoring Managers across Crinetics studies, including both in house regional CRAs and CRO CRAs.

• Conduct annual performance assessment activities for direct reports including appraisals, salary recommendations, and promotion justifications for Crinetics employees.

• Responsible for all Clinical Monitoring recruiting activities including interviewing, hiring, onboarding, and orientation processes for Crinetics Clinical Monitoring Mangers, CRAs and FSP CRAs.

• Accountable for high quality delivery of Clinical Monitoring activities for both insourced and outsourced studies in compliance with regulations, GCPs, Crinetics processes, defined KPIs, metrics, and other performance indicators.

• Ensure Clinical Monitoring completes all company, functional and study-level training on time.

• Responsible for administrative oversight of direct and indirect reports such as expense reports, travel approvals, and time-off requests.

• Support Clinical Monitoring Managers, CRAs, study team, and Quality with preparation and responses to audits or inspections.

• Act as a point of escalation for clinical study and Clinical Monitoring teams.

• Accountable for accuracy and completeness of the Trial Master File as it relates to Clinical Monitoring activities.

• Develop and manage Clinical Monitoring functional resource and budget requirements.

• Develops, at a minimum, short-term (<2 years) operational strategy for Clinical Monitoring.

• Manage Clinical Monitoring staff at the Associate Director level and below, generally with a management tree of up to 10 employees.

• Leads Clinical Monitoring and cross-functional strategic and technology initiatives as a Clinical Monitoring subject matter expert.

• Support development of other functional area processes and associated tools/templates.

• May conduct Monitoring Assessment visits for in house CRAs or participate in any other visit types for Crinetics studies.

• Other duties as assigned.

Education and Experience:

Required:

• BS in biological sciences or related discipline with at least 12 years of experience working in the biotechnology/pharmaceutical industry.

• A minimum of 8 years in a supervisory role

• Prior experience with Electronic Systems such as EDC. TMF, CTMS and IWRS required.

• Experience in all stages of drug development/pharma (study start-up, maintenance, database lock etc.) and strong understanding of clinical trial processes, protocols, and medical terminology; experience using risk-based monitoring processes.

• Demonstrates critical thinking, root cause analysis and problem solving to support CRAs and Clinical Monitoring Managers with identifying site process failures; assist CRAs to develop corrective and preventative actions to bring sites into compliance.

• A deep understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. Able to comply with safety standards and respect privacy and confidentiality.

• Excellent writing skills as they relate to the preparation of clinical trial documents.

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

• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.

• Experience in managing teams (including external service providers and consultants).

• Demonstrated leadership and management skills.

• Excellent judge of risks and a keen ability to analyze options and manage outcomes.

• Familiarity of Regulatory Affairs as applicable to clinical data and report filings

• Well-versed with the latest trends in the clinical trial industry

Preferred:

In-depth experience with cross functional drug development with prior regulatory inspection experience being highly desirable

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: $163,000 - $204,000

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.