Senior Director, Pharmacovigilance Operations

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 incumbent will provide oversight for the Pharmacovigilance (PV) Operations elements of the pharmacovigilance function. This includes overall accountability for vendor management/oversight; training; business integration; Quality Management System (QMS); Safety Data Exchange Agreements (SDEAs); PV Safety database; and Budgets. This position will also lead, and actively contribute to, the development or revision of existing PV processes related, but which may not be limited to: Quality, standards, and training. The incumbent works cross-functionally with internal departments/key stakeholders and external resources on pharmacovigilance-related matters.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc.
• Participate in process improvements and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post marketing surveillance.
• Accountable for business integration including safety data migration and integrating new assets or companies into Crinetics PV system.
• Accountable for development or revision of SOPs, work instructions, guidance in regard to all functions within PV.
• Participate in investigator meetings as needed to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor; receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements; interface with medical monitors for medical assessment and regulatory classification of SAEs; manage and facilitate SAE reconciliation across projects to ensure compliance with objectives and goals, adverse event follow-up and case closure.
• Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements.
• Accountable for working with relevant internal departments, and actively contributing to, the development of the PSMF.
• Work closely and collaborate with EU and local Qualified Person (QP) to develop new or maintain pharmacovigilance processes supporting both development and marketed/commercial products.
• Develop SDEAs or pharmacovigilance agreement with Crinetics partners and vendors for specific obligations for safety data exchange and reporting.
• Build relationships and collaborate with Clinical Development and Clinical Operations to improve process for safety reporting, reconciliation of safety data and protocol template development.
• Build relationships, and collaborate with, Regulatory Affairs Operations to improve process for safety reporting to global Health Authorities (HA).
• Contribute to inspection readiness and lead HA inspections of Crinetics’ pharmacovigilance function.
• Responsible for PV budgets, MSA and SOW with PV vendors.
• May manage, coach and mentor direct reports.
• Performs other tasks and assignments as needed.

Education and Experience:

• Bachelor’s degree in healthcare including BSN/RN, RPh, PharmD degree and a minimum of 15 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 5 of which were spent in a leadership role within pharmacovigilance.
• Extensive professional experience in pharmacovigilance and clinical safety.
• A proven track record of success in a leadership position within pharmacovigilance.
• Previous functional management experience, including mentoring and coaching of manager-level pharmacovigilance professionals within your line or as a deployed relationship.
• Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
• A proven history of successful involvement of driving strategic, global, cross-functional initiatives.
• A commercial mindset, including an ability to implement new services within an organization and interact with external stakeholders.
• Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
• Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA negotiations, vendor management and oversight, etc.
• Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• High energy, organized, persistent and creative individual with strong communication and interpersonal skills.

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 15% of your time.

The Anticipated Base 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.

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.

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.