124 days ago on sjobs.brassring.com

Global Program Medical Director - Cardiometabolic

Novartis Pharma Schweiz AG

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Global Program Medical Director - Cardiometabolic

Job ID 196638BR Position Title Global Program Medical Director - Cardiometabolic Division PHARMA Business Unit Global Develop NPH Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Therapeutic/Disease Area Cardiovascular and Metabolism Job Type Full Time Employment Type Regular Job Description The Global Program Medical Director (GPMD) is the global clinical leader responsible for the global scientific and medical strategy and accountable for the development and execution of the Clinical Development Plan (CDP) designed to support decision milestones, regulatory approval/market access, and budget targets for one or more treatment indications or programs, depending on the size, nature and complexity. The GPMD leads the Global Clinical Team (GCT), is a core member of the Global Program Team (GPT) representing Clinical Development, and together with Drug Safety and Epidemiology (DS&E) owns the risk benefit assessment of the program(s).

- Accountable for excellence in the clinical strategy, development and execution of an endorsed CDP in line with the Target Product Profile (TPP) designed for successful global regulatory approval/market access for one or more treatment indications or programs, depending on the size, nature and complexity

- Accountable for delivering high quality Clinical Trial Protocols (CTPs), the execution, acquisition and reporting of high quality data from clinical trials consistent with CDP and aligned to achieve the TPP for all Development clinical trials associated with the program

- Accountable for creation of and giving critical input to clinical components of key documents (e.g., regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s), and ensures the quality of all clinical documents produced by the GCT

- Together with DS&E, responsible for ensuring continuous evaluation of drug safety profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) and is a core member of the Safety Management Team (SMT)

- Leads the GCT, represents Clinical at GPT and may serve as the NIBR Interface Representative at the clinical/project teams for early development of compounds assigned to the therapeutic area (TA)

- Supports the Therapeutic Area Head (TAH) in leading the peer-review of CDPs and other clinical documents across various indications and programs and in driving excellence in clinical trial strategy, design, and execution. This includes CDP, protocol synopsis, CTP, CTP reviews, and development of disease/program clinical standards

- Serves as clinical/medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g, Research, Translational Medicine, Global Medical Affairs (GMA), Marketing), and internal decision boards

- Works closely with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed

- Plans and executes publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing

- Ensures career development of other clinical 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 GCT members as appropriate

- Responsbile for medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training

- Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program. Supports team to manage, forecast, and allocate resources (FTEs and budget) for the clinical program as needed. Accountable for timely execution of clinical deliverables within approved budget

- May serve on or lead global process improvement work streams, act as Subject Matter Experts for training or SOP development, and/or contributes to other Clinical Development line function initiatives

Please note that the position can be based either in Basel Switzerland or East Hanover USA.
Minimum requirements Education (minimum/desirable):
MD or equivalent (preferred), PhD, or PharmD degree required. Specialization in a subspecialty may be required. 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 2 through 3

Advanced knowledge of assigned therapeutic area is desired, 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

Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively in compelling presentations

Demonstrated ability to establish strong scientific partnership with key stakeholders

Thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process

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; ≥ 6 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 communication skills, written and oral

Strong interpersonal skills

Excellent negotiation and diplomatic skills, experience with submissions and health authorities required