Director, Medical Research

POSITION SUMMARY:

As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Director of Medical Research. The Director, Medical Research, is responsible for supporting strategic and operational activities of the Medical Affairs department and other functions at Intercept (e.g., R&D, Medical Safety) through real world evidence (RWE) generation. An integral part of Medical Affairs Research is the conceptualization and execution of scientifically credible research on Intercept products and their disease states/therapeutic areas. The development of a strategic evidence generation plan involves internal and external stakeholders to identify the most important research questions that will beneficially impact patient care. Successfully answering these questions will require the design of research that is fit for purpose (including pharmacoepidemiology research, registries, Health Economics and Outcomes Research (HEOR), oversight of investigator-initiated research plan, etc.) with partnerships from other parts of Medical Affairs, Publications and Scientific Communications, Pharmacovigilance, Clinical Development, Market Access, and Commercial functions.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily, with or without an accommodation:

• Collaborate with cross-functional colleagues to lead the development and execution of Medical Research strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources

• Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits/risks potentially associated with Intercept products

• Project management oversight – ensuring effective design, initiation, and implementation of real-world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and, where appropriate, contracting with partner organizations

• Provide epidemiological, HEOR, patient-reported outcomes, or/and RWE consulting and support to brand teams, program teams, and safety, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the team

• Assist with development of epidemiology sections for relevant regulatory documents and/or other regulatory filings for products throughout life cycle

• Collaborate with Scientific Communications team and Medical Directors in development and communication of key literature analyses to internal stakeholders; provide strategic support of publication planning and participate on Publications team to provide medical and scientific oversight to publication and scientific presentations

• Serve as scientific knowledge support through expertise in company products and related therapeutic area(s) to internal stakeholders

• Stay up-to-date on new data and developments in the field, key publications of interest, research methodologies and regulatory standards

• Represents Intercept at medical meetings, conferences, advisory boards, outreach meetings at key institutions and in interactions with thought leaders, as relevant

• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority

Requirements

QUALIFICATIONS:

• MD, PhD, MPH, PharmD, RN or PA with at least 5 years’ experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research

• Prior experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication

• Launch team experience and hepatology/GI experience strongly preferred

REQUIRED KNOWLEDGE AND ABILITIES:

• Solid understanding of the cross-functional drug development lifecycle and processes (Business Development, Clinical Trial Design, Conduct & Endpoint Selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)

• Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs

• Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level

• Strong knowledge of pharmacoepidemiologic methods

• Strong understanding of drug development and commercialization concepts

• Strong verbal and written communication skills are essential

• Strong interpersonal skills and problem-solving capabilities

• Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs

• Ability to work successfully in a matrix and quick-paced environment

• Ability to multitask priorities to align with program objectives

• Ability to work independently in a proactive manner

• Ability to create, track and plan timelines and budgets

• Proficient in Microsoft Excel, PowerPoint, Word

• Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows

• Consistent demonstration and embodiment of our company core values: Come Together, Be Yourself, Own The Solution, Embrace The Challenge, and Keep Exploring

• Ability to have fun and thrive in a growing, diverse, and inclusive work environment

Benefits

COMPANY CULTURE:

People at Intercept are passionate about patients. You’ll see our patient photos lining our walls and hear their stories in town halls. We’re equally passionate about our team and ensuring each member from all dimensions of diversity feels included and has the opportunity to reach their potential. We recognize the power of a diverse, equitable and inclusive (DEI) work force, and how it enriches the professional lives of our team members. Diversity, Equity, and Inclusion drives innovation and connects us to the patients and communities we serve.

At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. As we grow, we want to make every effort to provide a safe and open environment for professionals of every background and provide knowledge on how to work inclusively and equitably to make Intercept a great place to work.

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. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.

COMPANY SUMMARY:

Intercept is a biopharmaceutical company with a mission to build a healthier tomorrow for people living with rare and serious 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. In 2016, Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow.

Intercept continues to build on our ongoing commitment to people living with PBC by progressing our research portfolio with a novel fixed-dose combination of OCA and bezafibrate. Phase 2 analyses of this combination were presented at the European Association for the Study of the Liver (EASL) congress in June of 2023 and the American Association for the Study of Liver Diseases (AASLD)’s The Liver Meeting in November of 2023. Further, we are leveraging our decades of research and background in bile acids and FXR agonism to expand our pipeline in other liver diseases, such as severe alcohol-associated hepatitis (sAH).

COMPENSATION & BENEFITS:

The anticipated starting salary range for this position is $190,000 to $250,000. This represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range, based on various factors including, but not limited to, experience, skillset, and performance.

The salary range listed is just one component of our total compensation package. Successful applicants will also be eligible to receive annual bonuses at the discretion of the Company. Intercept also provides a competitive suite of benefits, including:

• 401(k) plan with company match

• Rewards and recognition program

• Health care benefits (medical, prescription drugs, dental, and vision insurance)

• Short and long-term disability coverage provided

• Parental leave benefits

• A generous Paid Time Off program of 20 days per year

• 12 paid holidays per year

• 4 paid Personal Days per year

• 2 paid Volunteer Days per year

• Numerous well-being and work-life programs

EEO Statement

Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law. This organization participates in E-Verify (E-Verify's Right to Work guidance can be found here: https://www.e-verify.gov/sites/default/files/everify/posters/IER_RighttoWorkPoster.pdf).

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