Function as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under the leadership of the GCPH. Support GCPH for cross program activities required for large or complex programs such as co-development partnerships.
1.Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Global Clinical Program Head (GCPH). Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications.
2.Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates.
3.Manages budget and resources (Budget and FTEs) in coordination with Global Clinical Program Head (GCPH) and Lead Clinical Trial Head (LCTH) ensuring timely execution of assigned clinical deliverables within approved budget.
4.Supports GCPH (and/or Sr. GCL) and may lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Exploratory Development, Early Clinical Development, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
5.Supports GCPH in ensuring overall safety of the compound in collaboration with the Brand Safety Leader for the assigned program section.
6.Leads the ICT if there is a separate ICT for the assigned program section with guidance from GCPH or Sr. GCL. Periodically attends Global Program Team (GPT) meetings and provides input. May act as the program spokesperson in internal and external meetings/boards.
7.Contributes to development and ensures implementation of across program specific standards (e.g. CRF s, outsourcing specifications, data monitoring and validation plans, analysis plan) for all trials to ensure consistency within the program section and across the entire brand.
8.Leads development of clinical sections of program level regulatory documents such as Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
9.Ensures career development of functional reports and other OGD colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of ICT members as appropriate.
10.Serves occassionally as faculty member for OGD training programs, author or reviewer for clinical SOPs.
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MD required with more than 4 years advanced knowledge in medical/scientific area. Oncology/Hematology experience a plus but not required.
Languages: Fluent oral and written English.
> 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
> 1 year of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing), or section of clinical programs in a global/matrix environment (including remote) in pharmaceutical industry.
1 year people management experience required, this may include management in a matrix environment. Global people management experience desirable.
Strong management, interpersonal, communication, negotiation and problem solving skills.
Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
Medical/scientific expertise in disease area of assigned program.
Understanding of global regulatory environment including key regulatory agencies and approval processes.
Strong understanding of operational aspects of all phases of clinical trial conduct (Start up, Conduct, Close out).
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