Corporate Counsel- Legal Affairs

Job Description

Intercept Pharmaceuticals, Inc. (the "Company") is a rapidly growing global biopharmaceutical company headquartered in New York City with its research and development operations located in San Diego and its international headquarters based in London. The Company is focused on bettering the lives of patients through the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases. The Company’s first product, Ocaliva® (obeticholic acid or "OCA"), was approved for the treatment of primary biliary cholangitis ("PBC") by the U.S. Food and Drug Administration ("FDA") in May 2016 and the Company commenced sales and marketing of Ocaliva in the United States shortly after receiving approval. Ocaliva received conditional approval for the treatment of PBC from the European Commission in December 2016 and the Company commenced its European commercial launch in January 2017. Since January 2017, Ocaliva has also received regulatory approval in several of the Company’s target markets outside the United States and Europe, including Canada, Israel and Australia. PBC is a chronic, progressive liver disorder that mostly affects women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.

The Company’s lead product candidate is OCA, which is being studied for the potential treatment of nonalcoholic steatohepatitis ("NASH"). In February 2019, the Company announced positive topline results from the planned 18-month interim analysis of its pivotal Phase 3 clinical trial of OCA in patients with liver fibrosis due to NASH, known as the REGENERATE trial. OCA has received breakthrough therapy designation from the FDA for the treatment of NASH patients with liver fibrosis. The Company filed for approval of OCA for NASH in the United States in September 2019 and intends to file in Europe in the fourth quarter of 2019. The Company is also conducting a Phase 3 trial in NASH patients with compensated cirrhosis, known as the REVERSE trial. NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH, and as early as 2020, the disease is projected to become the leading cause of liver transplants in the United States. There are currently no medications approved for the treatment of NASH.

POSITION SUMMARY:

The Company is currently seeking a talented lawyer to join our U.S. Legal Team, as Corporate Counsel, Legal Affairs. The position will report directly to the Executive Director, Legal Affairs and will be responsible for (i) contract related support, (ii) management of global contract processes and templates, (iii) management of the Company’s global privacy program, (iv) supporting HR matters, and (v) providing healthcare compliance and other legal advice.

Based at our global New York City headquarters in Hudson Yards, the successful candidate will be an experienced professional with deep substantive knowledge within his or her core functional responsibilities, strong management skills and the ability to work effectively with a small legal team. We are looking for a candidate who thrives in a challenging and interdisciplinary environment. The ideal candidate will be an experienced and pragmatic legal professional with excellent communication skills, high-energy, self-motivation and creativity.

CORE ACCOUNTABILITIES:

The successful candidate will be responsible for day-to-day legal matters within his or her core functional responsibilities, will work closely with internal clients (including members from the R&D, Commercial, Medical Affairs, Finance, HR, and IT Departments), as well as external and internal legal and compliance personnel. By way of example, the successful candidate’s specific responsibilities will include, but not be limited to, the following:

Lead the New York contract management team and support the Company’s global contracting needs.

Lead contractual negotiations with partners, collaborators, service providers, consultants and other vendors to ensure appropriate business and legal terms.

Draft and revise a broad range of agreements, including, supply and distribution agreements, licensing agreements, clinical trial agreements, master services agreements, and engagements with healthcare providers.

Assist in supervising a global contract management team, including outside legal consultants, law firms and other third-party vendors.

Effectively oversee the management of the Company’s contract management system and assist in ongoing periodic review and development of template agreements, contract playbooks, contract policies and procedures, contract management tools and resources, and training.

Manage and ensure on-time processing of contracts from initial request through execution, create and report on metrics and KPIs, monitor performance, and contribute to the constant improvement of contracting processes.

Assist in managing the overall quality control of contract management by providing direction in contract drafting, negotiation and compliance.

Effectively evaluate commercial and legal risk with respect to the Company’s contracts.

Assist in managing the Company’s global privacy program.

Manage HR related matters.

Support the US Legal Team in legal research, presentations and other projects, and provide contract management updates.

Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, and participating in professional societies.

Provide exceptional service to the Company’s operating units.

Other duties as assigned by the Executive Director—Legal Affairs.

QUALIFICATIONS/PROFESSIONAL ACCREDITATIONS REQUIRED:

JD from ABA accredited law school

8-10 years of relevant law firm and/or in-house experience. Experience working in-house for a biopharma company strongly desired.

Significant life sciences contracting experience, including supporting contracting needs for R&D, Commercial, Medical Affairs and enabling functions.

Experience drafting contract templates, playbooks and contract management policies and procedures.

Experience working on privacy and/or HR related matters a plus.

Experience working with a contract management system a plus.

Strong proficiency in Microsoft Excel, Word, PowerPoint, and Outlook.

Experience and Skills

Solid understanding of contracting in life sciences companies, including research, clinical and commercial contracts.

Strong leadership and management skills.

Strong written and verbal communication skills.

Ability to think creatively in confronting new issues.

Ability to manage multiple projects simultaneously.

Advanced knowledge of the practices, procedures, and processes involved in contract administration.

Practical, clear and organized; strong attention to detail.

Ability to work under pressure, meet deadlines and exercise sound business judgment.

Proven planning skills and ability to think creatively in confronting new issues and to think strategically in order to improve current processes.

Energetic person with high integrity who can represent the management team with professionalism interacting with peers, colleagues, industry leaders, and corporate executives.

Team player with a positive, can-do attitude.

Ability to complete tasks with little direction or need for supervisory follow-up, while having good judgment on when to seek guidance.

Ability to work effectively across a matrix organization.