POSITION SUMMARY:

As Intercept continues to build its position as the leader in rare and serious liver disease, we are seeking a Medical Director, Clinical Research. The Medical Director, Clinical Research provides oversight of medical activities that span across the clinical trials that are being conducted by Intercept Pharmaceuticals.

This position serves as a Subject Matter Expert (SME) and provides oversight for clinical studies, helping to ensure the safety and well-being of clinical trial subjects. Also serves as a critical conduit helping to ensure effective communications between stakeholders including: sites, CROs, CRAs, Clinical Development, and Medical Safety and Pharmacovigilance (MSPV). This role reports to the Vice President of Clinical Research.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

• Ensure that appropriate “day-to-day” medical monitoring activities (e.g., medical data documentation/review) occur consistent with protocols, SOPs, GCPs, and other requirements to support regulatory filings.
• Serve as the Medical Subject Matter Expert (SME), providing support to internal groups/stakeholders, CROs, and CRAs, (through ad hoc and scheduled cross-functional meetings, etc.).
• Provide medical support towards the development and execution of clinical trials including:
• Protocol development
• Training related to the study protocol, ICF, and IB
• Ongoing review of safety data
• Interpretation of trial results
• Support finalization of the clinical study report and other documents (e.g., DSMB charter, RMP, SAP, IB, ICF, reports to Health Authorities, etc.).
• Support responses to Health Authorities (audits, inspections, requests), IRBs, Ethics Committees, etc.
• Aggregate blinded safety data review
• Automated tools for use in medical data review & safety analysis
• Contribute to and/or author documents including budgets, Medical Monitoring contracts and plans (e.g., Medical Monitoring Plans – MMPs, and Medical Data Review Plans – MDRPs).
• Collaborate with cross-functional teams (internal and external staff) to address medical and safety issues in real time (e.g., protocol deviations, inclusion/exclusion criteria, lab alerts, hepatic safety issues, IP interruption, dose modification, rechallenge).
• Work with Clinical Operations and others to help identify significant safety issues that may impact overall project plans and initiate contingency plans as appropriate (e.g., subject retention strategies).
• Maintain close cooperation with the Medical Safety Pharmacovigilance team to support Safety Evaluation & Risk Management (e.g., support the interpretation of medical safety issues and provide regular safety updates from ongoing trials).
• Oversight management of vendors such as CRO’s, CRA’s, Labs etc.; ensure compliance with related SOPs, regulations, and support CAPA/deviation management.
• Oversight of medical data review by CRO’s to ensure that line listings, queries, IP decisions, lab alerts, periodic reviews etc. are being managed (meeting quality and timeliness criteria per the MDRP and archived as directed, e.g., eTMF) and escalated as appropriate.
• Contribute to departmental resource planning, budgeting and timeline setting to meet company needs.
• Contribute to and collaborate with Medical Affairs, medical research for publication planning.
• Ensure appropriate resource planning, e.g., Medical Monitors, Research Scientists, CRAs, etc., are assigned to adequately support current and upcoming clinical trials.
• Provide medical support via cross-functional collaborations into the product strategy and development program (e.g., CSR reviews, DMC reviews, and other adjudication committees, etc.).
• Identify the gaps in medical oversight management and contribute to continuous/process improvement.
• Other duties as assigned.
• 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 degree, Board Certified or Board Eligible with experience in Clinical Research/Development within biotechnology or pharmaceutical industry.
• Prior industry experience (CRO or Pharma) in medical monitoring activities. Prior industry experience (CRO or Pharma) leading / contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents, regulatory interactions preferred.
• Clinical and/ or research experience in Hepatology, Gastroenterology, Internal Medicine, Endocrinology/Diabetes, Cardiovascular/Lipidology or related field, preferred.
• Active engagement in relevant associations and hepatology-related professional communities is desired.

REQUIRED KNOWLEDGE AND ABILITIES:

• Knowledge of GVPs, GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• Strategic thinker, driven toward teamwork, excellence, and continuous improvement.
• Demonstrated ability as a medical / clinical expert in a complex matrix environment.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
• Detail-oriented, with strong organizational, prioritization, leadership, and time management proficiencies. Must be able to work on multiple projects simultaneously.
• General familiarity with biostatistics and clinical data review; expert in navigating scientific literature, interpretation of data, display of data (e.g., JReview, SpotFire, etc.).
• 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 / applications (Excel, PowerPoint, etc.).
• Ability to travel, in some cases, internationally.
• Strong verbal and written communications skills
• 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.

COMPANY SUMMARY:

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.

At Intercept, our mission is to build a healthier tomorrow for patients 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. The first Phase 2 interim analysis of this combination was presented at the European Association for the Study of the Liver (EASL) congress in June 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 $ 237,930 to $286,000. 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%5FRighttoWorkPoster.pdf).