Crinetics Pharmaceuticals

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 Senior Manager, Corporate Compliance is responsible for assisting the Compliance department in developing, implementing, and maintaining an effective Corporate Compliance Program that supports and promotes a company-wide culture of ethics and compliance while ensuring all legal, regulatory, and ethical obligations of a pharmaceutical company are being upheld. The position will assist in executing the elements of Crinetics’ Compliance Program, with an emphasis on the management of training, policies and procedures, and communications...

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Develop, revise and maintain all compliance policies, procedures and written standards related to the Compliance Program
• Collaborate with key stakeholders within the Company to address their policies, procedures and other non-GxP written standards related to or impacted by the Company’s Healthcare Compliance Program
• In collaboration with Quality Affairs, serve as Document Control in the Company’s document management system (Veeva Vault) and manage the workflow and processes related to non-GxP written standards
• Serve as the LMS administrator for the release of all non-GxP written standards and generate metrics and reports to leadership as requested
• Develop, implement, and track employee training on all compliance policies, applicable laws, regulations and industry developments impacting the Company’s Healthcare Compliance Program
• Manage the legal and compliance component of new employee orientation and other compliance training at company and departmental meetings
• Partner with third-party vendor to manage and launch corporate wide training modules within the Company’s LMS system
• Collaborate with Compliance leadership and other cross-functional leaders to help support aspects of an effective Compliance Program
• Assist the Compliance team to objectively and independently conduct compliance audit reviews of business processes and activities to identify potential risks, assess internal controls, and evaluate the overall effectiveness of the Compliance Program.
• Maintain an up-to-date knowledge and understanding of federal and state laws and regulations, industry codes of conduct applicable to the Company’s policies, practices and operations, including but not limited to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, regulations regarding the promotion of marketed products, clinical trial regulations and the False Claims Act and Anti-Kickback statute.

Other duties as assigned...

Education And Experience

• Bachelor’s degree (advanced degree such as master’s degree preferred) with at least 12 years of compliance related experience
• Certification of Healthcare Compliance (CHC) and/or Certified Compliance and Ethics Professional (CCEP) preferred
• Previous experience in a compliance role including the day-to-day management and execution of training, policies and procedures, and communications program
• Demonstrated ability to work collaboratively across multiple departments with strong interpersonal and communication skills
• Ability to interact and present to various internal stakeholders
• Ability to successfully manage, synthesize and communicate complex information in an effective manner
• Ability to work independently, identify opportunities, explore options and recommend solutions through strong critical thinking, problem solving and decision-making skills
• Experience with change management working in a high growth environment 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 quarterly on-site meetings and up to an additional 5% of your time...

The Anticipated Base Salary Range

$148,000 - $170,000

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.