Global Program Clinical Head, CART Lymphoma

252175BR
Global Program Clinical Head, CART Lymphoma
The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access. The GCPH may contribute to disease area strategy
Leads the GCT, represents Clinical Development on the Global Program Team (GPT)
2) May serve as the Clinical Development Representative on NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP)
3) May support Business Development & Licensing (BD&L) activities
4) Post-DDP, leads the development and execution of the clinical strategy. Develops an endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
5) Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with IDP and TPP. Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical
Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surevillance. Serves as a core member of the Safety Management Team (SMT)
7) As the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards
8) Supports TAH with leading the peer-review of IDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution

9)May contribute to development of TA strategies
GPCH Page 2 of 3
10) Plans and executes publication and clinical communication strategy in coordination with GMA and Medical Writing, and provides input into key external presentations
11) Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)
12) Ensures career development of program reports through active participation in the performance management, talent review, and succession planning processes. Provides on-boarding, coaching, and/or mentoring support; develops and fosters Clinical Development culture; and contributes to the performance evaluation of GCT members
13) Responsible for medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
14) Leads or serves on global process improvement work streams, act as Subject Matter Experts for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development line function initiatives Key Performance Indicators
 Excellence in establishing clinical development strategy across various indications and programs with alignment across functions
 Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases
 Strong evidence of quality medical/clinical review of trial data, development of CSRs
 Supports TA through high quality contributions to CDP and protocol reviews
 Timely development of quality disease/program clinical standards, publications, and internal/external presentations
 Timely delivery and submission of high quality clinical program data
 External acceptance of clinical data and risk-benefit assessments by key decision makers including Health Authorities, pricing and reimbursement bodies
 Well managed, effective, and engaged GCT(s)
 Clearly demonstrates Novartis Values and Behaviors Job Dimensions
Number of associates:
Leads a team of up to 50 direct and indirect reports
Financial responsibility:
Overall lifetime clinical budget of program which can vary and be in excess of $100 million
Impact on the organization:
External
 Timely submission and delivery of high quality clinical program data to health authorities
 Effective interaction with and influence on key external decision makers (regulatory authorities, medical experts, pricing and reimbursement bodies
 Regulatory approval of key compounds (or new indications), as appropriate
 Optimized brand value throughout the life cycle
Internal
 Effective management and alignment of GCT
 Significant contribution to GPT
 Effective cooperation with NIBR, regional and country medical colleagues, and New Products line function; strong interactions with various stakeholders across NIBR, Clinical Development & Analytics, Trial Management, GMA and Marketing
 Recruitment and development of talent to achieve a high performing organization
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MD or equivalent (preferred), PhD, or PharmD degree required. Specialization in a subspecialty may be needed. Advanced clinical training/knowledge in medical/scientific area aligned with TA required. Medical Board certification preferred for MD or equivalent; Clinical practice experience ≥ 4 years (including residency) preferred for MD or equivalent
Languages:
Fluent oral and written English
Experience/Professional requirement:
 ≥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
 Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
 Experience with submissions and health authorities required
 Demonstrated ability to establish strong scientific partnership with key stakeholders
 Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry
 ≥ 5 years people management experience required, this may include management in a matrix environment
 Considerable organizational awareness including significant experience working cross-functionally and in global teams
 Excellent management, interpersonal, communication (both written and oral), and problem solving skills
 Excellent negotiation and diplomatic skills

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Global Drug Development
CD&A GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular