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.

Education and Experience:

Required:

• 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