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Global Medical Affairs Director Remibrutinib

NovartisBarcelona, Cataluña, España

Hace 4 días

Descripción del trabajo

Location : London, UK or Barcelona, Spain

Role Type : Hybrid

The Global Medical Affairs Director leads the medical strategy and tactics for a Remibrutinib program / indication, ensuring the US and International medical perspective is reflected. They will develop, own and drive the execution of the Integrated Evidence Plan (IEP), ensuring the right evidence is available at the right time to enable access and clinical adoption of our assets. They will also act as a strategic partner to Biomedical Research (BR), Development, International Medical Affairs, US Medical Affairs, Strategy & Growth and Commercial.

About The Role

Major accountabilities :
Development and execution of high quality medical strategy for the asset / indication and vision throughout its lifecycle at global level.
Creation and execution of the integrated evidence plan addressing US and International top market needs and supporting clinical adoption of the asset, including interventional trials, real-world evidence (RWE), data mining, IITs, etc.
Design, set-up and execution of interventional clinical trials.
Serve as disease area medical expert for internal stakeholders from different line functions as well as external customers.
Partner with Development, Strategy & Growth (S&G), US and International cross-functions to diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for the asset.
Financial tracking to ensure timely development and execution of medical activities.
Prepare Specification Review Committee (SRC) submissions for Therapeutic Area (TA) assets within remit.
Represent GMA around prioritized portfolio with internal and external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators / partners.
Provide proactive input to asset lifecycle management on potential new therapeutic indications to consider.
Ensure that Patient Access programs are supported and delivered with full compliance.
Ensure GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards.

Education

MD or equivalent (preferred), PhD, or PharmD degree required

Specialist Degree or specialist qualification related to discipline for which the role is responsible is an advantage

Key Skills & Experiences

5+ years in Pharmaceutical Industry experience in Medical Affairs and / or Clinical Development

Experience working cross-functionally

Immunology experience and expertise

Successful development and execution of innovative medical strategies and a broad range of medical tactics and Integrated Evidence Plans

Track record of successful high-quality evidence generation projects

Good working knowledge of Good Clinical Practice (GCP) and evidence generation activities, including interventional and non-interventional studies and Real World Evidence (RWE), with scientific communication of results

Experience with advisory boards, steering committees, sponsorships, congresses, symposia, publications or external partnerships

Deep understanding of health care systems and key external stakeholders (HCPs, payers, medical societies, guideline committees)

Ability to identify unmet medical needs and generate the right evidence to address them, using innovative, multichannel communication formats

Strategic mindset with the ability to influence across a matrix organization to drive change

Why Novartis

Novartis is committed to helping people with disease and their families. Join a community of smart, passionate people who collaborate, support and inspire each other to achieve breakthroughs that change patients’ lives.

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Medical Director • Barcelona, Cataluña, España