The VP, Clinical Research will provide leadership and broad scientific and/or medical input to activities that span across the scope of clinical development, including leading strategic planning and execution of clinical development plans, providing medical support of regulatory submissions, contributing to/leading the development and execution of the medical affairs plan, and providing medical input to commercial initiatives.
The successful candidate must be able to perform each of the following satisfactorily.
Major responsibilities include:
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
- Oversee the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information, the commercial organization, expert advisors and key opinion leaders, payers and commercial advisors, and professional organizations.
- Contribute to departmental resource planning, budgeting, and timeline setting to meet company needs
- Direct line management and mentorship to clinical research personnel
- 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
Key Activities & Responsibilities:
- Lead the strategic planning and execution of clinical development plans
- Provide clinical/scientific 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
- Lead or contribute to the interactions with, and support of, relevant Data & Safety Monitoring Committees
- Medical support and/or authoring of clinical and regulatory documents including NDA/MAA, DSUR, briefing documents, regulatory responses, investigator brochure; Participate in regulatory interactions
- Support product lifecycle management for new indications as directed by Development Lead
Experience and Skills
- MD degree with a minimum of 12 years of direct biotechnology or pharmaceutical industry experience in Clinical Research. Prior medical practice experience highly preferred.
- Prior experience in Hepatology, Gastroenterology, Diabetes, Cardiovascular/Lipidology or related field, preferred.
- Prior industry experience contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents.
REQUIRED KNOWLEDGE AND ABILITIES:
- Knowledge of 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 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. (Average travel expectations: <20%/year.
- 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!