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Associate Director - Medical Affairs

Associate Director - Medical Affairs

NOVARTIS

10 - 15 years

27 - 30 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

medical affairs networking gcp diversity and inclusion clinical development nis pharmacovigilance subject matter expert associate director

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area.
Develops/ owns IEP and provides input into development while ensuring US and Intl medical perspective is reflected.
Is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects.
Based on extensive experience in drug development will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise.
Will act as a subject matter expert in the development of the overarching strategies, providing inputs during design and along the end-to-end execution of programs across different disease areas.
Will provide leadership and deep medical expertise in the TA, pivoting support based on business priorities and will represent GMA with senior stakeholders when needed
Acts a strategic partner to NIBR, Development, International Medical Affairs, US MA
Acts as Global Medical Affairs responsible for review of Managed Access Programs (MAPs) Acts as Global Medical Affairs responsible for Post Study Drug Supply (PSDS)
Represent Global Medical Affairs at GPTs and be a strategic partner to life-cycle management of In-Market brands
Responsible for medical information related activities to the Therapeutic Area

Key Responsibilities

Lead development and execution of medical affairs strategy for TA/Asset priority programs including transformative tactics such as research/population health, innovative partnerships and integrated evidence plans.
Co-develop plans for evidence generation, MSL / Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development with Tas.
Partner with Development, SG, US and International cross-functions to shape portfolio early and diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for priority programs.
Represent GMA around prioritized portfolio with internal and external audiences, in collaboration with TAs including the investment, medical and regulatory communities, as we'll as pharmaceutical or biotechnology industry collaborators/partners.

Provide proactive input to Development on potential new therapeutic indications, to enrich Registration Programs and to consider new therapeutic opportunities.

Create MAP treatment strategy worldwide plan for compounds and seek leadership endorsement, in co- ordination with line functions including program safety.

Development of patient consent / assent, product form, baseline / follow-up questions, Statistical Analysis Publication Plan (MSAPP) other relevant activities, as applicable.

Develop PSDS cover letter to highlight any new or additional compound-specific information for the physician (eg relevant risk minimization materials)

Essential Requirements

MD (Preferred) or PhD/PharmD in Health Sciences. Specialist Degree or specialist qualification related to discipline for which you will be responsible is an advantage.
At least 10 years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical Development
Critical thinker and with ability to navigate uncertainty with major supervision.
Fluent oral and written English; Other relevant languages are an advantage.
Able to establish credibility and influence across a range of diverse stakeholders in a matrix organization to drive change.
Ability to truly collaborate across functions and markets serve-partner-co-create.
Able to navigate in an environment of shared outcomes and cross-business accountabilities.

Firm working knowledge of GCP, scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.

Desirable Requirements

Highly preferred TA expertise, significant medical affairs early asset lifecycle, pre-launch and launch experience.
Experience in developing and executing Best in Class processes at scale.
Clinical trial research experience conducted in a pharmaceutical or equivalent academic environment in TA of interest is strongly desired.

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