At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name "Ocaliva®," is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva®was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva®launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), which impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.
The Vice President, Medical Safety (MS) & Pharmacovigilance (PV), will lead the strategic management, planning and execution of the global Medical Safety and Pharmacovigilance organization, including Medical Safety, Pharmacovigilance Operations and Safety Surveillance & Risk Management. S/he will ensure operational efficiency, provide the highest level of compliance with all regulatory safety obligations, and lead a highly strategic function that guides Intercept's approach to drug development and approved medicines from a safety perspective. This leader will translate business vision and strategy into a functional vision while leading an industry-leading PV team, compliant with appropriate regulations and industry standards. This position will be responsible for the management and conduct of all MS and PV activities and operations, whether internally conducted or out-sourced, including Safety Surveillance and Risk Management groups. S/he will also partner with R&D around drug development and regulatory, and with Medical Affairs around epidemiology research needs. The position reports to the SVP, Medical Affairs, Safety & Pharmacovigilance and can be based either in New York, New York or San Diego, California.
The successful candidate must be able to perform each of the following satisfactorily:
- Lead the MS and PV team and operations (including external resources) globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
- Report, respond and resolve safety questions from regulatory authorities, respond to regulatory agency audits and corrective action plans.
- Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
- Oversee Aggregate reporting, risk-benefit profiles, medical monitoring, and risk mitigation plans for clinical and post-marketing compounds.
- Maximize organizational efficiency through outsourcing and other resource management.
- Provide ongoing updates to senior management on the changing risks-benefit profile of products in clinical trials as well as commercialized medicines and implement appropriate safety updates and risk mitigation plans.
- Provide Pharmacovigilance support to internal and external customers.
- Lead process improvement within PV and MS, including technology assessment and implementation.
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, and serious adverse event handling and all other MS/PV issues, as appropriate.
- Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community.
- Successfully plan and forecast for global resources and budget and partner with other groups on resource needs (e.g., medical research for writing and statistical staffing; medical affairs research for epidemiology project needs).
- Implement global process standardization and improvement.
- Develop and manage an industry-leading PV team, including recruitment, training, assessment, monitoring and development. Translate business vision and strategy into functional vision and communicate company/departmental information effectively to the team.
- Provide scientific strategic leadership for Pharmacovigilance and safety expertise to other Intercept departments and functions.
- Ensure that the team is able to meet safety monitoring needs based on regulatory requirements and company standards and are audit-ready.
- Oversee development of training modules and provide training in Pharmacovigilance across the Company.
- Other duties as assigned
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- Medical Degree (MD, DO) is required; specialty training / board certification, especially in gastroenterology/hepatology, is strongly preferred.
- Over 12 years of experience in the pharmaceutical industry, including at least 5 years in a leadership/management position in Medical Safety and PV.
- Expert knowledge of FDA and EMA safety regulations, ICH guidelines, and global safety regulations.
- Experience building and optimizing a Pharmacovigilance and Drug Safety organization/function including experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
- Executive presence with the ability to communicate and influence effectively to varied audiences, both internally and externally.
- Comfortable and adept at balancing risk and opportunity.
- Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations.
- Experienced in attracting, hiring and mentoring top talent.
- Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Strong and dynamic leadership skills, with excellent written, verbal and presentation skills.
- Effective team player, who fosters collaboration within and across functional areas.
- Strong knowledge of Pharmacovigilance technologies.
REQUIRED KNOWLEDGE AND ABILITIES:
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem-solving capabilities.
- Proven meeting planning skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Understanding the legal and compliance environment
- Ability to have fun and thrive in a growing, diverse and inclusive work environment!