Medical Information Director

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

Crinetics is seeking a Medical Information Director to act as a medical information specialist in our developing Medical Affairs department. This role is critical for the accurate and timely dissemination of medical information as Crinetics approaches FDA-approval of several products and considers global commercialization of an exciting pipeline. This position interacts with internal stakeholders such as clinical research, sales & marketing, regulatory, and research teams to obtain necessary updated information of both investigational and marketed products, and to inform other stakeholders of new issues that may arise. You will provide guidance and direction pertaining to the receipt, processing, and dissemination of safety information and ensure dissemination of medical information meets regulatory guidelines and follows Crinetics SOPs. This is a fun and inspiring time at Crinetics, and we welcome those who can joyfully handle the excitement and continuous improvement that comes with launching new products.

Essential Job Functions And Responsibilities

These may include but are not limited to:

• Learn the science of complicated disease states and detailed data of research projects across multiple products to be the “go-to” person for internal and external questions about the science.
• Participate in the maintenance and continuous improvement of a product knowledge database that is easily accessible to answer external inquiries proficiently
• Create and maintain accurate and fair-balanced standard response letters (SRL) and custom responses to unsolicited external medical information requests
• Work with colleagues globally to reconstruct and potentially organize the translation of SRLs based on different global regulations
• Prepare, along with other internal teams, for multiple product launches in succession, including managing med info responsibilities of investigational products and applying the unique compliance guidelines that accompany the pre-approval period.
• Manage high-performing partners and vendors, such as a call center, to support compliant responses to unsolicited requests for medical information, as well as intake and triage of AE and PQC case reports in conjunction with the Pharmacovigilance Team
• Provide guidance on the receipt, processing, and dissemination of safety information and ensure all safety information is handled in compliance with regulatory guidelines and internal protocols
• Establish, track, and report KPIs for inquiry volume, turn-around times, and customer satisfaction
• Act autonomously as the main MLR reviewer on one or more products
• Lead the coordination of scientific congresses for Medical Affairs activities in the US and globally, potentially in multiple countries in the EU, UK, Latin American, and Asia and provide in-person medical information support, including booth-related activities and materials
• Lead global implementation of medical information, including imminently establishing call centers in the EU, UK, Germany, and Latin America (with others closely behind).
• Collaborate with Clinical Research, Sales & Marketing, Regulatory, and other internal experts to obtain necessary product information and updates
• Inform internal stakeholders of new issues or developments that may impact product knowledge or medical information dissemination
• Participate in the preparation and submission of reports to regulatory agencies and help ensure all reports are accurate, comprehensive, and submitted within required timelines
• Ensure the dissemination of medical information complies with regulatory guidelines and follows established SOPs
• Stay informed of changes in regulations and adjust processes and practices accordingly
• Help identify data gaps and contribute to generation of medical insights to support company and functional strategic planning
• Participate in the development, updating, and distribution of AMCP or other payer- related dossiers
• In partnership with the medical communications team, monitor and maintain a bibliography of relevant scientific literature and disseminate new publications internally
• Provide scientific training to vendors and internal colleagues as needed
• Monitor industry trends and innovations and implement best practices to heighten efficiency, quality, and value of medical information.
  
  

Required

Education and Experience:

• Advanced degree in a scientific or medical discipline (PharmD, MD, PhD)
• Minimum 8 years of experience in medical information and medical affairs in the pharmaceutical/Biotech industry
• Excellent communication and interpersonal skills, with the ability to effectively interact with a wide range of internal and external stakeholders
• Detail-oriented with strong organizational and problem-solving abilities
• Proficient in using medical information databases and other relevant software tools
• Collaborative, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization
• Strong desire to avoid conflict among colleagues and to focus on efficiency
  
  

Preferred

• Endocrinology, rare disease, and oncology experience
  
  

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.

Travel

You may be required to travel for up to 25% of your time.

The Anticipated Base Salary Range: $181,000-226,000

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.