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Associate Medical Director, U.S. Medical Affairs

Job Description

COMPANY SUMMARY:

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. In 2016, Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow.

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 and for which there are currently no available treatments. The 18-month interim analysis of the REGENERATE study of OCA remains the only readout from a Phase 3 trial to have shown positive results in the disease.

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 di¬fference in the lives of patients, Intercept is a great place to be.

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking an Associate Medical Director, U.S. Medical Affairs, who will be responsible for contributing to and participating in the development of the U.S. Medical Affairs (USMA) strategy and tactical plans and then helping to execute them by driving certain key aspects for Intercept's commercialized and pipeline indications/brands, focused on the U.S. market. The ideal candidate should be highly motivated and innovative with a clear ability to manage a matrix, multiple ongoing tasks and responsibilities, and have a track record of successful execution of deliverables.

The Associate Medical Director shall have responsibilities for key aspects of the USMA strategy and tactics and ensure aligned execution against the strategy in collaboration with the other Medical Affairs functions (Field Medical, Medical Research, Medical Operations, Scientific Communications, etc.). This individual will also be responsible for collaborating with other matrix partners (such as Commercial, Research & Development, Regulatory Affairs, Corporate Affairs, Business Development, and Program Teams) to ensure appropriate Medical Affairs input and direction are provided. Additionally, the Associate Medical Director will partner with the Executive and Senior Medical Directors for NASH and PBC to ensure and continuously improve the high-quality deliverables for the USMA team.

Through the development and maintenance of relationships with the external expert community/stakeholders (including gastroenterologists, hepatologists, and associated advanced practice providers [APPs]), the Associate Medical Director will utilize his/her/their skills and relationships to advance Intercept's medical/scientific engagement and excellence in scientific research, advisory boards, medical education, and scientific communications.

CORE ACCOUNTABILITIES:

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

* Participate in the development of a cross-functionally aligned set of medical strategies for the U.S. market needs, focused on commercialized as well as late-stage development indications/assets
* Develop the strategy for professional medical association engagement in the U.S. in conjunction with other U.S. stakeholders as part of the broader professional society strategy
* Lead the strategic development and execution of the Top Thought Leader Engagement initiative in the U.S. in conjunction with cross-functional colleagues across NASH and cholestasis
* Support medical affairs data generation and dissemination working group(s) and collaborate with the Scientific Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts
* Support field medical activities and help to assess and address internal/external medical education needs in collaboration with the Field Medical and Scientific Communications teams
* Perform scientific and clinical training for internal staff, including Commercial/Sales, on Intercept products and respective disease-related aspects
* Conduct scientific/medical presentations to external stakeholders (e.g., healthcare professionals, agency partners, societies, advisors, etc.)
* Provide substantial input and reviews development of Medical Information Letters and the Global Value and AMCP Dossiers as needed
* Lead, attend, and execute advisory boards related to key topics of interests for NASH and PBC
* Participate in scientific congress planning and execution of these plans as part of the cross-functional team, providing medical input on key activities and engagements
* Participate in or perform review of promotional and medical/scientific materials as the Medical Reviewer, following standard operating practices (SOPs) and in collaboration with Regulatory, Legal, and Commercial counterparts
* Serve as content expert in NASH and cholestasis and master the data in support of Intercept's products' value proposition
* Develop subject matter expertise and stay current on new data and developments in the field and key publications of interest
* Maintain strong relationships with the external thought leader and influencer communities
* Contribute to, and support execution of the lifecycle management activities for Intercept's commercialized indications/assets
* 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 as our top priority

Experience and Skills

QUALIFICATIONS:

* MD/PhD/PharmD (or equivalent) with a minimum of 5 years of professional/clinical experience, preferably with at least 3 years of biopharmaceutical industry experience in Medical Affairs and/or Clinical Research is required
* Other biomedical degrees (e.g., NP, PA, MSPharm, MPH, MS) with a minimum of 5 years of professional/clinical experience, preferably with at least 3 years of bio-pharmaceutical industry experience in Medical Affairs and/or Clinical Research; those without an advanced degree with at least 8 years of relevant bio-pharmaceutical industry experience in Medical Affairs and/or Clinical Research will also be considered
* Experience working with professional societies and quality organizations preferred
* Prior experience in Hepatology, Gastroenterology, or Immunology preferred
* Strong understanding of drug development and/or commercialization process

REQUIRED KNOWLEDGE AND ABILITIES:

* Track record of being held accountable for key individual deliverables with successful results required
* Strong verbal and written communication skills are essential, including strong presentation skills
* Excellent organization and multi-tasking skills
* Strong interpersonal skills and problem-solving capabilities
* Demonstrated ability to perform and lead across a matrix required
* Ability to work independently in a proactive manner
* Proficient in Microsoft Project, Excel, PowerPoint and Word, plus prior experience producing impactful and clear professional-quality PowerPoint data and/or scientific presentations
* 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

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Associate Medical Director, U.S. Medical Affairs

Morristown, NJ 07960
Full Time

Published on 11/19/2022

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