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. OCA, marketed under the brand name \"Ocaliva ® ,\" is approved in the U.S., EU and Canada for certain patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva ® was the first product to be approved for PBC in over twenty years and our team is proud to have been pioneers in providing the first second-line treatment option to patients with such critical need. The Ocaliva ® launch in 2016 also marked Intercept's successful transition from a development-stage company to a fully integrated commercial organization with continued growth.
In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (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. 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 submitted the first new drug application for a NASH treatment to the U.S. FDA in September 2019. 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 Senior Statistical Programming will play a pivotal role in preparing the company for the successful anticipated launch of OCA's second indication.
Provide broad scientific and/or medical input to activities that span across the scope of Clinical Research & Pharmacovigilance, including contribute to/lead the strategic planning and execution of clinical research plans, provide medical support of regulatory submissions, contribute and provide medical input to commercial initiatives and medical affairs. This position also serves as medical monitor (and provides oversight of contract medical monitors) for clinical studies providing medical safety surveillance and helping to ensure the safety of clinical trial subjects.
This role reports to the Executive Medical Director of Safety Evaluation & Risk Management.
This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.
The successful candidate must be able to perform each of the following satisfactorily:
- Medical safety oversight for ongoing clinical trials throughout the trial conduct and support all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including medical safety interpretation of results, clinical study reports and graphical displays.
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
- Maintain close collaboration and cooperation with Pharmacovigilance colleagues focused on Safety Evaluation & Risk Management.
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents.
- Conduct and have oversight over Intercept medical monitoring activities and co-lead interactions with the Data Safety Monitoring Committee.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Provide medical safety expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization.
- Maintain close collaboration and cooperation with clinical operations on the safe implementation and execution of clinical studies.
- Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific and medical safety data disclosures.
- Contribute to departmental resource planning, budgeting and timeline setting to meet company needs.
- Provide oversight and coaching to more junior medical safety & clinical research personnel.
Key Activities & Responsibilities:
- Contribute to/lead the strategic planning and execution of medical safety clinical development plans
- Provide medical input during the development and execution of clinical trials including protocol development through the review and interpretation of trial results and finalization of the clinical study report
- Medical support and/or authoring of clinical safety and regulatory documents including NDA/MAA, DSUR, briefing documents, regulatory responses, investigator brochure; Participate in regulatory interactions
- Provide medical safety support to lifecycle management activities as planned by Development Lead
- Provide medical support cross-functional collaborations to integrate broad medical, safety, scientific, and commercial input into the product strategy and development program
- As Medical Safety subject matter expert contribute to the strategic planning, authoring, and review of medical and commercial support documents and initiatives including manuscripts, abstracts, posters, FAQs, standard response letters and promotional material
- Maintain close collaboration and cooperation with clinical operations on the safety aspects of implementation and execution of clinical studies.
- Identify significant safety issues that may impact overall project plans and initiate contingency plans as appropriate
- Leading and managing direct reports and matrix teams
- Other duties as assigned
- 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
- MD degree with a minimum of 7 years of biotechnology or pharmaceutical industry experience in Clinical Research Medical Safety
- Prior clinical experience in Hepatology, Gastroenterology, Endocrinology/Diabetes, Cardiovascular/Lipidology or related field, preferred.
- Prior industry experience as a medical monitor contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Pharmacovigilance, Medical Affairs and Clinical Trials monitoring activities.
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.
- Demonstrated ability as a medical safety 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 good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
- General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data.
- 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.
- Highly proficient in standard computer software (Word, Excel and Power Point).
- Ability to travel, in some cases, internationally. 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
- Understanding the legal and compliance environment
- Ability to have fun!