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Vice President, Clinical Development San Diego United States,
Posted on : 13 December 2016
The Vice President, Clinical Development will provide functional leadership and clinical leadership for the Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include strategic leadership in the assigned therapeutic area(s), design and ownership of the clinical development plan, KOL liaison and management, serve as a key member of the Portfolio Management Committee (PMC), clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications and presentations.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Responsible for the design and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products.
- Oversee the medical directors on selected product development candidate programs. This includes facilitation of designing clinical trials and an overall clinical development strategy leading to global product registration.
- Serve as a key member of the Portfolio Management Committee and work across the organization and provide clinical research insights across the multiple program teams
- Maintain a clinical development team with line management of the Clinical DMPK, Clinical Science, Biostatistics and Data Management, and Medical Writing departments.
- Interpret results of Phases 1 through Phase 3 clinical investigations in preparation for new drug applications to relevant regulatory authorities.
- Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents.
- Provide clinical development support for company activities and manage physician consultants and collaborators in the clinical research program.
- Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed).
- Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community.
- Help represent the Company as needed as a senior Clinical spokesperson to a variety of scientific, business and government groups/agencies.
- Develop and maintain yearly and long-term budget and resource plans for the all departments within Clinical Development
- Mentor and support the career development of the Clinical Development team, encouraging the consistent use of our Core Values
" Additional duties and responsibilities that may be assigned from time to time
- Advanced degree (MD, Pharm D or PhD)
- 15+ years of Clinical Development experience obtained in the Pharmaceutical Industry and excellent knowledge of the drug development process. The ideal candidate will have hands-on experience of designing and conducting clinical trials in both gastrointestinal and hepatology areas. Additional experience in other therapeutic areas within the company portfolio would also be an advantage
- Must have experience of working in a leadership role within the development project team e.g. member of a core project team, sub-team leader, etc.
- Proven proficiencies with a wide range of data/information: scientific/clinical, legal/regulatory, business, financial and market analytics
- Strong communication skills (including writing and presentation skills) with success in influencing at all levels cross-functionally
- Proven leadership abilities in a highly complex and fast paced environment where negotiation skills were essential for success
- Excellent business acumen and demonstrated ability to align teams to the corporate strategy and drive to achieve business and project objectives
- Experience working with corporate partners would be an advantage.
San Diego CA United States
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