Medical Director, Medical Safety & Pharmacovigilance – Post - Market Safety

Intercept Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 31 days ago

Job Description

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 potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name 'Ocaliva,' is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.

Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA's second indication.

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 potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name 'Ocaliva,' is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.

Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA's second indication.

POSITION SUMMARY:

This position accepts considerable responsibility for the medical safety management of drugs in clinical development and in the post-marketing (preferred) setting. The position requires strong analytical skills and the capability to effectively contribute as a strong team player.

This position will lead the ongoing signal detection monitoring, product risk-benefit assessment, and safety assessment activities of designated drugs and/or indications. The Medical Director will work closely with the Medical Safety & Pharmacovigilance team and in addition will be a key member in one or more cross functional clinical development.

ESSENTIAL FUNCTIONS:

  • Performs medical review of post-marketing reports.
  • Contributes to the preparation of, reviews, and approves aggregate safety reports required by health authorities such as, Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), etc.
  • Manages compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA) etc. for the reporting of adverse events to Regulatory Authorities
  • Represents Medical Safety & Pharmacovigilance in communications with Health and Regulatory Authorities
  • Provides medical input for maintaining REMS, RMP, and post-marketing safety monitoring commitments
  • Leads signal detection activities, authors signal analysis reports and provides periodic benefit-risk assessment reports. This includes the investigation and review of emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports from published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources
  • Develops and maintains current pharmacovigilance knowledge and ensure that team is aware of new and existing relevant procedures, guidance, and regulations
  • Is an active member in internal Medical Safety & Pharmacovigilance review committee meetings
  • Other duties as assigned

Clinical Safety Activities (Desired but not required):

  • Serves as the Medical Safety & Pharmacovigilance Lead for designated indications or drug portfolio(s) including providing after hours coverage for urgent/emergent medical queries related to clinical study conduct and patient safety.
  • Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
  • Authors, reviews and provides input and approval for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
  • Provides medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives, compiles analysis of similar events (AOSE)and supports ad-hoc safety analyses as required by health authorities
  • Represents Medical Safety & Pharmacovigilance at independent Data Safety Monitoring Committee meetings
  • Contributes to regulatory filings (including NDAs/MAAs) and responses as needed

Experience and Skills

QUALIFICATIONS:

  • Doctor of Medicine, US board certification or board eligibility preferred but not mandatory.
  • Preferred specialties include Gastroenterology, Internal Medicine
  • 5 years minimum experience in the role of Medical Safety Physician or similar pharmacovigilance leadership role in the pharmaceutical industry
  • Strong skills in the management of safety information originating from both clinical development and post-marketing sources
  • Expert knowledge of the regulations governing pharmacovigilance
  • Working knowledge of industry standard pharmacovigilance databases
  • Strong leadership skills and ability to communicate with individuals at all levels
  • Excellent oral and written communication skills
  • Excellent analytical skills and ability to work independently
  • Strong interpersonal, negotiating and team building skills
  • Ability to exercise creativity and judgment


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