Manager, Centralized Start Up

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 Manager, Centralized Start-up will support centralized study and site activation activities with a focus on leading the detailed review, negotiation, and acceptance of informed consent documentation for Crinetics clinical studies that is compliant with ICH GCP, Crinetics internal processes, and local regulations.  Incumbent will also support and/or coordinate study-start up activities such as feasibility, site identification, essential document collection and tracking, and site activation.  The Manager will also support or develop processes related to informed consent review and study start-up activities.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Lead country and site-level review, negotiation, and acceptance of new and updated informed consent documentation to ensure compliance with ICH GCP, internal processes and local regulations for countries/sites managed in-house by Crinetics.
• Support the cross-functional generation of study-specific master informed consent documentation.
• Optimize ICF documentation and review capabilities to align with study timelines and milestones.
• Support and/or coordinate the end-to-end study start-up process including feasibility, site identification, IRB/IEC submissions, essential document collection, and site activation for insourced countries.
• Collaborate with Contract Research Organizations, Clinical Trial Operations, Legal, Clinical Research, and other appropriate functions to ensure compliant informed consent documentation, effective tracking of study start-up activities, and timely site activation.
• Partner with Clinical Trial Operations and Clinical Monitoring to develop start-up package and Investigator Site File templates.
• With support from leadership, identify, manage and mitigate risks related to informed consent documentation review/approval and overall study start-up.
• Maintain, report, and action study start-up KPIs and metrics, including informed consent form review and completion status, to internal and external teams.
• Create, maintain, and/or review any start-up or site activation plans as needed on assigned studies.
• Develop or support development of informed consent and study start-up processes, procedures, tools, and job aids.
• Support inspection readiness as informed consent process/documentation and study start-up subject matter expert.
• Other duties as assigned.

Education and Experience:

Required:

• BS in biological sciences or related discipline with at least 7 years of experience working in the biotechnology/pharmaceutical industry. 
• Demonstrates knowledge of informed consent documentation and process requirements.
• Direct experience reviewing, negotiating and finalizing informed consent documentation at a site and country level.
• Direct experience working in study start-up activities such as feasibility, essential document templates and completed packages, and IRB/IEC submissions and approvals.
• Demonstrates critical thinking, root cause analysis and problem solving skills.
• Strong knowledge and demonstrated application of Good Clinical Practices and regulatory requirements.
• Excellent writing skills for the preparation of compliant clinical trial documents.
• Excellent interpersonal skills with strong oral/written communication and presentation skills, including strong ability to collaborate cross-functionally.
• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• Demonstrated leadership and management skills.
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Well-versed with the latest trends in the clinical trial industry

Preferred:

• Supervisory experience of two or more years.
• Experience working in the Endocrine therapeutic area.
• Prior regulatory inspection experience preferred.

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.

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 Range

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.