Senior Director, Pharmacovigilance Operations

Crinetics Pharmaceuticals • Headquarters, KY

1d • $243,000 - $303,000

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• 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
• winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees