The Clinical Leader, Established Products (CL-EP), is involved in the lifecycle management of a variety of marketed products across a diverse group of therapeutic areas. The areas are divided into three portfolios: Women’s Health and Urology (also includes Antifungals, Antihelminths, and Oncology); Pain/CNS (Psychiatry and Neurology); and Internal Medicine (Anti-Invective’s, Gastroenterology, and Cardiovascular). The CL-EP position supports the Therapeutic Area Portfolio Management Team and is dedicated to maximizing the value of this portfolio through the execution of all phases of clinical development. The CL-EP provides active medical and scientific contribution to cross-functional clinical teams to enable worldwide registrations for new indications and enhancements to the label.
PRINCIPAL RESPONSIBILITIES:
- The CL-EP works with the Global Labeling Teams, Regulatory Affairs and Client to update the Core Date Sheets, SmPCs, USPIs and other local labels for products within the therapeutic areas.
- Leads Clinical Teams in the fulfillment of Phase IV commitments and other projects as required by regulatory authorities.
- Collaborates with international teams on
- Responses to requests from Health Authorities, worldwide
- Phase-3 registration studies conducted by operating companies
- Timely implementations of corrective actions as needed.
- Executes clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications.
- The CL-EP leads teams for preparing development plans, protocols, CSRs and documents for regulatory filings.
- The CL-EP is responsible for medical monitoring and safety reporting of clinical studies, acts as a liaison between company and investigators, and develops relationships with opinion leaders and key regulatory officials.
- Participates in cross-functional teams for evaluation of new product ideas; reviews medical literature and related new technologies.
- The EP-CL provides active medical and managerial leadership for the operational implementation and execution of clinical programs through matrix management of cross-functional teams.
- Medical and scientific problems are discussed and solved within teams.
- Managerial issues are addressed at an individual basis and if necessary escalated to the line manager.
- Leads in the interpretation, reporting, and preparation of results of product research, in the setting of world-wide health authority submissions, including FDA and/or EMA submissions.
- Is accountable, or responsible as appropriate, for medical monitoring & reporting and safety officer activities, evaluating, as necessary, adverse events (Clinical-trial and spontaneous, post-marketing) for relationship to treatment
- The CL-EP reports to the Established Products Portfolio Leader and is accountable for deliverables on assigned projects within the portfolio with the highest quality and within agreed upon timelines and budgets.
- The EP-CL acts in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant FDA, EMA, or other Health Authorities, advisory committees, and review meetings (e.g. pre-NDA meeting).
- The EP-CL is a core member of the Compound Development Team (CDT), is a leader of the Clinical Team, and is a member of the Global Labeling Team (GLT) and Safety Management Team (SMT).
- The EP-CL acts as a liaison between company and investigators, and develops relationships with opinion leaders and key regulatory officials.