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.
EDUCATION & EXPERIENCE REQUIREMENTS:
- This position requires an MD/DO degree. Board Certification in respective Therapeutic Area is desirable.
- Additional training in Therapeutic Area, PhD in a relevant discipline, or business/management training (MBA) is desirable.
- A minimum of 2 years of academically based research experience is required.
- A minimum of 5 years of drug development experience is required.
- A minimum of 5 years highly successful industry/CRO experience is strongly preferred.
- Managerial/supervisory experience strongly preferred.
- Up to 15-25% yearly travel required (International and Domestic).
- Energy and enthusiasm are essential.
- Outstanding oral and written communication skills (including report development) essential.
- Success working in a Matrix environment a strong plus.
- Candidate should possess strong problem solving skills for developing creative solutions and meeting project objectives.
- Candidate should have demonstrated ability of strategic thinking and contingency planning with respect to EP TA objectives.
Kind Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - 732-662-7964
