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 marketed under the brand name \"Ocaliva ® \" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Director, Compliance and Continuous Improvement. This position provides critical strategic and tactical support to Medical Safety & Pharmacovigilance, and is responsible for:
- Program leadership of business improvement initiatives
- Leadership of the Compliance, PVA, Training, and PSMF Team
The successful candidate must be able to perform each of the following satisfactorily.
Program leadership of business improvement initiatives:
- Ownership of the MSPV Strategic Planning Process and tracking of progress to goals
- Proven ability to troubleshoot and analyze system, business process, and quality issues and provide solutions for improvements (e.g. propose the creation of new systems and processes to optimize operations)
- Leadership of MSPV Business Excellence initiatives and liaise w/other pharmas/vendor(s) as appropriate for benchmarking toward best practices
- Oversight of MSPV initiatives: developing and tracking activities against timelines, collaborating to align teams on project objectives and timelines, administering the day-to-day activities, including tracking costs, facilitating communication between internal groups as well as with external partners to ensure that project/contract deliverables are met, providing technical and administrative support by meeting regularly, ensuring that projects remain on track and within budget, working with the Finance group to implement and track budgets
- Serves as pharmacovigilance expert and provides leadership for cross-functional, organization-wide projects or initiatives; including driving decisions and bringing together important stakeholders
- Provide business/technical input on requirements gathering, system configuration/optimization, training documentation & process improvement initiatives
- Ensure clarity of mission and accountability for critical program objectives; assure alignment of program objectives with corporate goals.
- Proactively define program strategy, goals, decision points and potential areas of risk and/or risk mitigation.
- Clearly define team structure, roles and responsibilities to meet program goals; facilitate coordination and alignment across functions.
- Identify need for external expertise and engage outside experts.
- Serve as primary spokesperson for programs; regularly communicate program progress and issues to key stakeholders, senior management, and external advisory committees.
- Foster a team culture of ownership, continuous evaluation and improvement; ensure recognition of team achievements.
- Contribute expertise to the continuing development of the program management function to help further needs of the business.
- Provide governance and budget cycle support to the V.P. MSPV and assist with other responsibilities as assigned.
Leadership support to the Executive Director, MSPV Operations, Compliance and Case Processing of the Compliance, PVA, Training, and PSMF Team:
- Leadership, management, and development of Compliance, PVA, Training, and PSMF team members
- Oversight of the pharmacovigilance (PV) quality and compliance system including establishing standards, agreements with partners, PSMF and related documents, department training requirements, monitoring department performance, implementing continuous improvement actions and good documentation practices.
- Collaboration with QA department to maintain a state of high PV inspection readiness across all regions/countries,
- Provide support for internal audits and global regulatory inspections.
- Maintain knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices
- Partner with PV Operations in the generation, review, approval and operational implementation of governing documents, such as SOPs and Work Instructions, as necessary.
- PV Vendor oversight support, including key performance indicator (KPI) metrics generation and review, contract compliance, quality and timeliness of deliverables and continuous improvement. PV vendors can include database providers, CROs and other vendors as needed.
- Ensure inspection readiness of vendors conducting PV activities through above-referenced KPI metrics review, vendor audit findings, CAPA generation and review.
- Provide functional support / input into PV vendor relationships including safety database holders, CROs and other vendors as required (e.g., business requirements, vendor selection, contract details).
- Support partner relationships through participation in Joint Pharmacovigilance Committees; generate and maintain Safety Data Exchange Agreements, as necessary; partner with PV Operations with regard to operational implementation of SDEAs/PVAs
- Provide support for department activities, including but not limited to review of core documents including Investigator Brochure (IB), protocols and aggregate reports.
- Provide pharmacovigilance training and training documentation for investigator meetings, vendors, CROs and partners, as required.
- Identify need for external expertise and engage outside experts as appropriate.
- Serve as primary spokesperson for programs; regularly communicate progress and issues with key stakeholders
- Adheres to company policies and applicable regulations including reporting of adverse events to regulatory agencies
- Interfaces with other departments (e.g. clinical development, clinical operations, regulatory affairs, data management, biostatistics) regarding safety data collection, analysis, and reporting.
- Other responsibilities 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
- BS degree in nursing, pharmacy, or other health care or life sciences related profession;
- Minimum 8 years of experience in Drug safety/Pharmacovigilance quality and compliance in a pharmaceutical industry setting or the equivalent
- Successful leadership / senior level experience in global pharmacovigilance quality and compliance oversight
- Proven track record of successful team and project management experience (minimum of 5 years managerial experience)
- Prior experience with timeline management and budgetary responsibility
- Advanced degree (MA, MS, MPA, JD, MBA, PhD) desirable.
- Experience with project management tools and software (e.g. MS Project)
- PMP certification or training
REQUIRED KNOWLEDGE AND ABILITIES:
- Proven experience as a program leader with project management expertise and direct supervisory experience
- Knowledge of principles and practices of Program and Project Management.
- Ability to drive high-level decision-making.
- Ability to work independently and productively and set priorities across multiple projects with little supervision.
- Exhibits leadership skills that promotes team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to lead global, cross-functional, cross-cultural, and matrixed teams.
- Expert knowledge of FDA, EMA and other international legislation and ICH PV guidelines.
- Strong analytical and problem-solving skills; strong presentation skills.
- Experience in all aspects of safety reporting from case intake and processing, through expedited and periodic reporting for spontaneous and clinical trial cases, and signal detection, risk management and communication, PV audits and inspections.
- Experience with Argus Safety database and/or other safety databases is a plus
- Experience with overseeing and managing vendors
- Solid organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
- Proficient in standard computer software (Word, Excel and Power Point)
- Strategic thinker, data-driven and analytical in approach to solving problems
- Excels at building relationships and networks; influences others to achieve outcomes
- Detail oriented with high standards and a reputation for integrity and quality.
- Strong verbal and written communications skills
- 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
- Ability to have fun and thrive in a growing, diverse and inclusive work environment