Associate Director, Risk Management Coordination

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 (AD), Risk Management Coordination (AD, RMC) will lead Risk Management study activities in Clinical Operations. The AD, RMC will represent Clinical Operations in cross-functional discussions related to Risk Management, Site Health/Performance Monitoring, Centralized Monitoring, and Quality Tolerance Limits. Incumbent will also lead or participate in discussions with Contract Research Organizations (CROs) on RMC activities, such as Risk-based Monitoring (RBM) and Site Health/Performance Monitoring. The AD, RMC will author or review Crinetics processes and tools related to the implementation of Risk Management, RBM, and Key Risk Indicators (KRIs) to manage site health and performance. Incumbent will support selection and implementation of Clinical Operations risk-based quality management (RBQM) technology.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Lead or participate in Risk Management activities on clinical studies including identification of critical processes and data, and risk identification, evaluation, control, review, and reporting.
• Partner with CROs and study team on execution of components of RBQM.
• Create internal RBM strategy for Clinical Operations.
• Lead or participate in discussions with CRO, Clinical Monitoring, and other internal functional areas related to RBM strategies for targeted or reduced Source Document Verification (SDV).
• Develop or implement KRIs, in collaboration with Clinical Monitoring, Clinical Trial Operations and CROs, related to Site Health/Performance Monitoring.
• Participate in cross-functional activities and/or deliverables related to Centralized Monitoring and QTLs to help establish and support a robust internal process to complement RBM strategies.
• Author or review Clinical Operations RBQM processes, tools, job aids and other support materials.
• Act as SME on study teams related to Clinical Operations RBQM activities, demonstrating strong industry knowledge.
• Contribute to study-specific plans related to Clinical Operations RBQM.
• Act as SME in development and implementation of RBQM enabling technology within Crinetics.
• Provide detailed training and change management to the organization to accelerate RBQM adoption in collaboration with AD, Centralized Processes and Training.
  
  

Required

Education and Experience:

• Bachelor’s degree in health sciences or related discipline.
• Minimum of 12 years of experience working in the biotechnology/ pharmaceutical industry. Must have at least 5 years of direct experience in Clinical Operations and Risk-based Quality Management.
• Demonstrated ability to develop RBQM methodology for an organization
• Experience in all stages of drug development/pharma (study start-up, maintenance, database lock etc.) and strong understanding of clinical trial processes and ability to assess for risks.
• A deep understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements. Highly advanced knowledge of ICH E6r2 and risk-based requirements.
• Experience with clinical trial systems such as eTMF and CTMS. Experience with RBQM technology is strongly preferred.
• Strong knowledge of industry RBQM methodologies such as Transcelerate (especially the RACT) and/or WCG Avoca.
• Strong interpersonal skills with advanced oral/written communication and presentation skills.
• Strong negotiation skills and a tactful approach to lead and influence cross-functional teams.
• Shows ability to think/plan strategically.
• Demonstrates problem solving, analytical and collaborative abilities.
• Proficiency in Microsoft office tools.
• Well-versed with the latest trends in RBQM in the clinical trial industry.
  
  

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 10% of your time.

The Anticipated Base Salary Range: $138,000-$172,000

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.