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 Monitoring, is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies for an assigned program or therapeutic area at Crinetics. This position is accountable for execution of all monitoring and site management activities on assigned program or therapeutic area including on-site and remote visits, investigational product accountability and management, participant recruitment and engagement, investigator site file review and reconciliation, and delivery of quality data. This role is also 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. This role will provide direct coaching and development support to Clinical Monitoring Managers (CMM). The role is also responsible for leading the 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 CMMs with study execution and oversight related to Clinical Monitoring, such as monitoring strategy, plans, and visit scheduling; support team with identification and communication of monitoring findings and risks with proposed mitigations.
- Lead team in building strong relationships with Principal Investigators, site staff, and vendors.
- Define and track metrics and key performance indicators (KPIs) to assess study performance and operational efficiency across assigned program or therapeutic area.
- Ensure CMMs track, 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.
- Manage and lead CMMs and, if needed, assigned Crinetics and FSP Clinical Research Associates (CRAs) responsible for Clinical Monitoring activities.
- Ensure adequate resourcing for all CRAs and CMMs across assigned studies/program, including both in house regional CRAs and CRO CRAs.
- Conduct annual performance assessment activities for direct reports including appraisals, salary recommendations, and promotion justifications.
- Responsible for all Clinical Monitoring recruiting activities including interviewing, hiring, onboarding, and orientation processes for CMMs, CRAs, and FSP CRAs.
- Lead selection of clinical monitoring vendors; support invoice review of clinical monitoring vendors on assigned program or therapeutic area.
- Deliver high quality Clinical Monitoring activities for both insourced and outsourced studies in compliance with regulations, GCPs, Crinetics processes, defined KPIs, metrics, and other performance indicators.
- Support assigned program or therapeutic as the clinical monitoring lead; oversee multiple clinical studies, with responsibility for the coordination of resources, timelines, and budgets.
- Participate at study meetings as operational program lead, including Development Sub-team, as applicable.
- Serve as escalation point for CMMs in the resolution of quality issues identified during the conduct of oversight monitoring activities.
- Conduct and/or participate in site engagement visits, as needed.
- Participate in the preparation and review of study budgets of CRO vendors (in relation to monitoring activities).
- Ensure CMMs and CRAs complete all company, functional, and study-level training on time.
- Provide administrative oversight of direct and indirect reports such as expense reports, travel approvals, and time-off requests.
- Support CMMs, CRAs, study team, and Quality with preparation and responses to audits or inspections.
- Ensure accuracy and completeness of the Trial Master File as it relates to Clinical Monitoring activities.
- Lead 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.
- Conduct Monitoring Assessment visits for in-house CRAs or participate in any other visit types for Crinetics studies as needed.
- Other duties as assigned.
Education and Experience:
Required:
- BS in biological sciences or related discipline with at least 10 years of experience working in the biotechnology/pharmaceutical industry.
- A minimum of 7 years in a supervisory role.
- 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 highly desired.
- 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.
- 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.
- In-depth experience with cross functional drug development with prior regulatory inspection experience being highly desirable.
- 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).
- 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:
- Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Prior experience with electronic systems such as EDC, TMF, CTMS and IWRS required.
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 20% of your time.
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.
Salary RangeThe salary range for this position is: $154,000 - $192,000.
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.
