Senior Manager, Medical Affairs Operations

Senior Manager, Medical Affairs Operations

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. 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. Come join our team as we transform the lives of others.

Position Summary :

The Senior Manager, Medical Affairs Operations, is responsible for managing the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies and post-trial access programs. The incumbent oversees the review, monitoring, and adherence to clinical protocols, taking ownership of key projects and working independently. The Senior Manager, Medical Affairs Operations, will interact internally and externally with members of the cross-functional study team and may supervise more junior managers and / or assistants as required.

Essential Job Functions and Responsibilities :

These may include but are not limited to :

• Provide oversight of clinical affairs programs across all functional areas of the drug development process, including post-trial access programs coordinating the continued provision of investigational product to participants, in accordance with regional regulations.
• Provide operational and strategic input into planning for expanded access programs and study specific documents such as synopses, protocols, ICFs, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plans, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Coordinate and lead study team meetings and provide key stakeholders with updates on program progress including timelines, budget, and key milestones for the program.
• Develop the subject recruitment / retention strategy and related initiatives.
• Oversee TMF set-up, ongoing quality review, and final reconciliation of study documents, including review of site regulatory documents / packages and obtaining of appropriate site insurance, and / or supervision of team members performing these activities.
• Develop training materials for the program team, investigational sites, and vendors.
• Manage information proactively by sharing with key stakeholders using standardized reports and other mechanisms.
• Assure programs are compliant with ICH / GCP and other regulations as appropriate.
• Oversee preparation of RFPs and prepare bid templates to facilitate selection of the CROs / vendors, and / or collaboration / supervision with team members performing these activities.
• Collaborate with counsel to negotiate and draft contracts and agreements with CROs / vendors and clinical sites, as needed.
• Act as liaison with Regulatory Affairs to assure adherence to GCPs, conduct maintenance of SOPs, and ensure site and CRO / vendor audits are completed.
• Perform study risk management and implement mitigations.
• Identify potential program issues and recommend and implement solutions or corrective actions as needed.
• Create realistic plans that clearly define goals, milestones, responsibilities and results.
• Maintain focus on strategic objectives while accomplishing operational goals.
• Make timely, data-driven decisions.

Education and Experience :

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.

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.

Compensation :

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.

Salary Range :

The salary range for this position is : $147,000 - $184,000. 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.