Global Program Clinical Head Neuroscience Early Pipeline
Novartis
Bâle, Canton de Bâle-Ville, Switzerland
vor 2 Tg.
source : Jobeo.ch

Description du poste : 60! With a 60-year history in neuroscience, Novartis has brought innovative therapies to patients with e.g.

Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Epilepsy, Depression and Migraine.

We have a world-class pipeline in neurodegeneration, neuro-inflammation, neuromuscular and psychiatric diseases.

Our holistic R&D approach includes cutting edge molecules, innovative approaches to technology, biomarker and digital therapeutics to seek better solutions for patients.

The Global Program Clinical Head (GPCH) early pipeline is the global clinical leader responsible for the clinical assessments of internal (NIBR) as external (BD&L) early clinical programs across indications in assigned TA.

The GPCH is accountable to support decision milestones, regulatory requirements and market access for those early compounds in collaboration with relevant other functions like DRA, New products, market access and others.

The GCPH contributes to the development and execution of the disease area strategy and the biomarker strategy Your responsibilities will include : 1) Contribute to development of TA strategies including biomarker if appropiate2) Serve (or his deputy) 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) Support Business Development & Licensing (BD&L) acitivities and is member of BD&L Search and evaluation team4) Pre-DDP, leads the development of the clinical strategy for GDD.

Develops an high level 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 programs5) Together with Patient Safety and if relevant Translational Medicine, ensures evaluation of drug safety profile and signal detection.

6) 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 boards7) 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 execution8) 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;9) Responsbile for medical / scientific training of relevant Novartis stakeholders on the disease area and compound / molecule.

    May serve as speaker for franchise medical / scientific training10) 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 Description du profil : What you'll bring to the role :

  • MD or equivalent required.
  • Specialization in a subspecialty may be needed.

    Advanced clinical training / knowledge in medical / scientific area aligned with TA required.

    Medical Board certification preferred

  • Advanced knowledge in medical / scientific area (e.g., oncology, hematology, endocrinology) required Fluent oral and written English development in an academic or industry environment spanning clinical activities in Phases I through III (some industry experience preferred)
  • 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
  • Experience with Bd&L acitvites including clinical stage compounds
  • 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 WHY CONSIDER NOVARTIS?750 million.
  • That's how many lives our products touch.

    And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people's lives?

    We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks. We are Novartis.

    Join us and help us reimagine medicine.

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