POSITION SUMMARY
The Senior Medical Director will join the Clinical Development group and will be responsible for all clinical trial related activities in all stages of clinical development in a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis, are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Senior Medical Director operates in collaboration with other functions including internal Safety and Clinical Operations teams.
JOB FUNCTIONS/RESPONSIBILITIES
- Leadership and management of all aspects of complex, global development clinical study program(s), from phase 1 through post-commercialization.
- Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
- Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
- Support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, etc.)
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
- Responsible for medical monitoring of efficacy and safety clinical trial data.
- Strategic input on the overall development plan, internal and external evaluation of new indications and studies.
- Oversight of medical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials.
- Collaboration in the analysis and writing of scientific publications/presentations.
- Works closely with other functions, in particular with Safety function and Clinical Operations.
- Co-leads Study Management Team with Clinical Operations lead.
QUALIFICATIONS
Education/Experience:
- MD, with a minimum of 5 years.
- Experience in Liver or rare disease preferred.
- Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.
Knowledge, Skills and Abilities:
- Demonstrated accountability for delivery on complex development plans.
- Leadership in clinical development programs and multidisciplinary trial teams.
- Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
- Ability to understand and communicate risks, as well as develop and execute contingency plans.
- Experience presenting data to regulatory agencies and advisory committees.
- Ability to think creatively and develop and execute in a fast-paced environment.
- Detail oriented with exceptional organizational skills.
- Effective communicator with strong verbal and written skills.
- Ability to identify issues, analyze situations and provide effective solutions.
- Solid understanding of the clinical development process.
- Knowledge of applicable regulatory.
- Willingness and ability to travel domestically and internationally is required; it is anticipated that this will be 30% of work time.
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