Associate Director, Centralized Training & Processes

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), Centralized Processes and Training is responsible for ensuring operational efficiency and effectiveness of Clinical Operations and OVG processes and training. The incumbent will be responsible for authoring, reviewing, and/or optimizing Standard Operating Procedures (SOPs), Work Instructions (WIs), and other tools and templates within the department and represent Clinical Operations and OVG in cross-functional process and training initiatives. The AD, Centralized Processes and Training, will play a pivotal role in leading change management initiatives to ensure rapid adoption and implementation of processes and systems within Clinical Operations and OVG.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Ensure oversight and adequacy of processes within Clinical Operations and OVG to ensure SOPs, WI, and other guidance documents reflect the way work is executed.
• Author, review, and/or optimize SOPs, WIs, and supportive tools/templates to standardize processes within Clinical Operations and OVG, and partner with QA to establish a cross-functional process review team.
• Identify and drive continuous improvement of processes to enhance operational efficiency and effectiveness.
• Centralize management of Clinical Operations and OVG-required training assignments and matrices.
• Conduct routine assessments of compliance with SOPs, WIs, and training programs; develop action plans to advance process compliance.
• Develop and deliver innovative training programs to build operational excellence capabilities within the team.
• Conduct department training on best practices, audit findings, industry updates, and other tools.
• Ensure completion and filing of departmental training.
• Conducts centralized Clinical Operations and OVG onboarding training.
• Analyze operational data to identify trends, root causes, and opportunities for improvement in partnership with Clinical Operations and OVG leadership
• Establish, track, and distribute metrics and key performance indicators to measure the effectiveness of processes and systems.
• Lead change management efforts to ensure successful implementation and adoption of process improvements and operational initiatives within and outside Clinical Operations and OVG.
• Serve as the centralized point of contact for department audit findings, evaluation, actions, and outcomes.
• Liaison with QA, Learning and Development, and other key stakeholders, within the organization.
• May perform other duties as assigned.
  
  

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 direct experience in Clinical Operations, including process development and training.
• Experience in all stages of drug development/pharma (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes.
• A deep understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
• Experience with clinical trial systems such as eTMF and CTMS.
• Excellent writing skills related to the preparation of clinical processes and training.
• Strong interpersonal skills with strong oral/written communication and presentation skills
• Strong negotiation skills and a tactful approach to leading and influencing cross-functional teams.
• Demonstrates problem-solving, analytical, and collaborative abilities.
• Demonstrated leadership and management skills.
• Experience with corrective/preventative actions and effectiveness checks.
• Proficiency in Microsoft Office tools and training technologies.
• Well-versed with the latest trends in the clinical trial industry
  
  

Preferred

• Advanced degree preferred
• Change management certification preferred
• Knowledge of operational excellence methodologies (i.e. Six Sigma) preferred
• Previous supervisory experience preferred
• Prior regulatory inspection experience is highly desirable
  
  

Physical Demands And Work Environment

Physical Activities: On a continuous basis, sit at a desk for a long period of time; intermittently answer the 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.