Global Program Clinical Head - Gene Therapies and Rare Disease

Seeking a Global Program Clinical Head (GPCH) for Gene Therapies and Rare Disease early development projects. The GPCH works to ensure early development plans and proof of concept studies are aligned with the Development strategy and leads licensing evaluations for Clinical Development for Gene therapies across various indications. As an integrative leader, the GPCH is accountable to support decision milestones, regulatory requirements and market access for those early compounds in collaboration with relevant other functions.
-Leads the strategic planning, execution, and delivery of all global clinical trials across all programs within the assigned TA. Complete oversight of budget and resource allocation within the therapeutic area – including enterprise review of resources across the TAs. Drives operational excellence through process improvement and knowledge sharing across the function. Develops an empowered organization which can navigate in a matrix environment and adjust quickly to business needs.

Major accountabilities:

• Interface from pre-PE through to TDP on standard and RDC priority Gene Therapy and Rare Disease projects and contribute to development of TA strategies including biomarker if appropriateServe (or his deputy) as the Clinical Development Representative on BR clinical/project teams to drive an end to end clinical strategy from First in Human (FIH) to  pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) TDP/FDP.Support Business Development & Licensing (BD&L) activities and is member of BD&L Search and evaluation team
• Leads execution on broad strategic direction and is responsible for delivering the portfolio and project priorities -Complete oversight of budget and resource allocation within the assigned area.
• Manages resources cross units and/or global projects which may involve managing large teams across multiple sites worldwide -Author/reviewer for relevant SOPs/ departmental procedures -Build best talent and an empowered culture to foster high performance -Drives operational excellence through process improvement and knowledge sharing in the assigned areas and/or across functions -May deputize for/represent functional head This is a generic description.
• Specific position profiles may vary by Division/Department/unique Position requirements -May deputize for/represent functional head This is a generic description.
• Specific position profiles may vary by Division/Department/unique Position requirements -Distribution of marketing samples (where applicable) This is a generic description.
• Specific position profiles may vary by Division/Department/unique Position requirements

Minimum Requirements:

• MD or MD/PhD in Neurology, Neuromuscular or Neurodevelopmental Disorders, Genetics, Pediatrics or Neuroscience background is strongly preferred 
• Advanced clinical training/knowledge in medical/scientific area aligned with TA required. Medical Board certification preferred for MD or equivalent; Clinical practice experience 10 years (including residency) preferred for MD or equivalent
• 6 years (MD or equivalent)/ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
• Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data

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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.