158 days ago on sjobs.brassring.com

Senior Global Clinical Leader

Novartis Pharma Schweiz AG

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Senior Global Clinical Leader

Job ID 194256BR Position Title Senior Global Clinical Leader Division PHARMA Business Unit CELL & GENE THERAPIES UNIT Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Function as clinical leader of a section of a clinical program (e.g., an indication/disease area, a new formulation, or a specific development phase), under the leadership of the Global Clinical Program Head (GCPH) or a Senior Global Clinical Leader (Sr. GCL). May support GCPH for cross program activities required for large or complex programs such as co-development partnerships.
Major Accountabilities:
1. Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with guidance from GCPH or Sr GCL. 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 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.
Minimum requirements Education:
Advanced degree or equivalent education/degree in life science/healthcare is required. MD strongly preferred.
Advanced knowledge in medical/scientific area (Oncology, Haematology, Endocrinology) required
Fluent in spoken and written English.
Professional experience:
• ≥ 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 approvals