Senior Medical Director, Pharmacovigilance
Categories: Pharmacovigilance
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 incumbent will be responsible for global pharmacovigilance for Company’s investigational and/or marketed products assigned to them, including review and analysis of safety data, providing medical expertise to assigned project teams, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review of aggregate reports. Responsible for keeping upper management informed of safety issues.
This is a critical role to ensure safety of patients taking Crinetics investigational and marketed products. May be assigned work of a more complex nature or a global product that is marketed with risk management programs.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Maintain expert knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds.
- Responsible for review of Individual Case Safety Reports (ICSRs). Ensure completeness and accuracy of safety information in ICSR through assessment of seriousness, expectedness, causality, MedDRA coding, review of narrative summary and provide case comments; provide medical inquiries for follow-up.
- Participate in individual project teams and provide medical input/expertise.
- Responsible for safety signal detection activities for assigned products and discuss safety signals as needed at Safety Review Team (SRT).
- Chair the SRT for responsible products and works effectively with all cross functional stakeholders (internal and external) to discuss and manages all new emerging safety signals from clinical trials and post marketing environment.
- Responsible for contributing and review of aggregate reports (DSUR, PSUR, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Draft the appropriate safety sections as well as Risk/benefit sections for aggregate safety reports.
- Support the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products.
- Provide medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
- Establishes good communication and foster relationship with cross boundary stakeholders including PV Vendors, and Crinetics Partners on all pharmacovigilance related issues.
- Responsible for the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.
- Contribute and review safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.
- Contribute to the strategy for NDA/MAA filing. Lead or contribute to the components of NDA/MAA dossier.
- Focus on immediate and short-term (<2 years) strategic planning horizon.
- Drive team objectives and goal setting, prioritization, and adherence to plan and strategy.
- Attend cross functional or project specific team meetings to provide medical expertise, as needed.
- Provide leadership, career management and personal development to direct reports.
- Perform other tasks and assignments as needed and specified by management.
Education and Experience:
Required:
- MD Degree required; experience with endocrinology or rare disease products is a plus, but not required.
- Hands-on clinical practice experience is desirable.
- Experience with NDA/MAA filing is a plus.
- A minimum of 13 years of Pharmaceutical Industry experience within the Drug Safety Department required, at least 10 of which were spent in a leadership role within pharmacovigilance.
- Global drug safety experience including depth and international regulatory authority experience required.
- Extensive knowledge of ICH/FDA guidelines for GCP and Clinical and post-marketing Safety Reporting.
- Ability to read, analyze and interpret scientific and technical journals.
- Must have experience in writing/oversight of Annual Reports, DSURs, PSURs, Type II Variations.
- Working knowledge of MedDRA coding and case series retrieval strategies.
- ·Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Ability to work with international collaboration partners and CRO’s.
- Must have very strong English language writing skills and mature verbal communication and presentation skills.
- Demonstrated decision-making and problem-solving skills coupled with a can-do attitude.
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. 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): N/A.
Travel:
This is a remote position, however, you may be required to travel up to 15%-20% of your time to support cross functional team activities.
The Anticipated Base Salary Range: $246,000 – $327,000
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.