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Senior Director, Clinical Pharmacology

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. 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.

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Senior Director, Clinical Pharmacology. This position provides leadership in characterizing the clinical pharmacology profile of compounds developed by Intercept as part of the overall pipeline.

Major areas of responsibility include the design and ownership of Clinical Pharmacology Plans, oversight of clinical pharmacology and pharmacometric aspects of clinical trial and program level activities, lead the evaluation and interpretation of clinical pharmacology data and strategic/expert contributions to regulatory submissions, publications and presentations.

This role will generally be the key point of contact for all clinical pharmacology-related activities across all therapeutic areas.

CORE ACCOUNTABILITIES:

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

  • Lead all clinical pharmacology aspects of clinical trial(s) and program level activities as assigned, providing subject matter expertise to study protocols, statistical analysis plans, interpretation of results, clinical study reports, etc.
  • Design Phase 1 studies and collaborate with the clinical team for selecting most appropriate PK sampling strategy for Phase 2 and 3 studies
  • Participate to dosing selection for Phase 1 studies in collaboration with the preclinical group, and for Phase 2 and 3 clinical trials based on pharmacometric data and in collaboration with medical teams
  • Deliver high-quality evaluation and interpretation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety, dose or concentration/response relationships).
  • Design and analyze cross-trial pharmacokinetic-pharmacodynamic analysis, conduct simulations (e.g., trial design, efficacy-safety in new populations) based on prior data and models.
  • Contribute to the strategic planning, authoring, and review of regulatory documents providing direct leadership/oversight to clinical and preclinical pharmacology sections of these documents; Serve as primary clinical pharmacology representative in support of regulatory interactions.
  • Contribute to protocol sections, analysis plans, study reports as well as regulatory documents (INDs, CTAs, NDAs, MAAs and Investigator's Brochure)
  • Provide subject matter expertise to scientific data disclosures including publications and commercial support documents, ensuring strategic intent is aligned with corporate and R&D strategy.
  • Provide subject matter expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
  • Build productive relationships with investigators, key opinion leaders, and key stakeholders in the medical/scientific community.
  • Management of personnel within the Clinical Pharmacology line function
  • 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

QUALIFICATIONS:

  • PharmD or PhD in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences or related discipline
  • Minimum 8 years of industry experience in clinical pharmacology and/or clinical PK/PD
  • Ability to integrate biological systems, physiology, pharmacology, and biochemistry with PK/PD and drug development.
  • Demonstrated record of overseeing the successful planning and implementation of clinical and preclinical pharmacology components of development plans and global regulatory submissions.
  • Experience developing overall resource plans (both internal resource and outsourcing) and providing oversight to vendors/CROs
  • Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin or similar software
  • Experience with NONMEM, R and other modeling software
  • Experience managing direct reports preferred


REQUIRED KNOWLEDGE AND ABILITIES:

  • Ability to work in a matrix environment and with different leadership styles
  • Proven ability to work independently, proactively, and effectively
  • Proven leadership abilities in a highly complex and fast-paced environment where negotiation skills are essential for success. Must be able to work on multiple complex 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.
  • 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



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Senior Director, Clinical Pharmacology

New York, NY
Full Time

Published on 11/13/2021

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