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Your tasks and responsibilities
The primary responsibilities of this role, Head Medical Affairs Early Phase Franchise -Oncology, are to:
Delineate the Medical Strategy for Oncology pipeline asset(s) that complements the Development Strategy;
Plan and coordinate the design, conduct, analysis, reporting and publication of Oncology Global Medical Affairs Studies;
Provide strategic review of Oncology IIR, collaboration and PMC studies;
Ensure all regional studies are consistent with agreed Global Medical Strategy;
Provide scientific and medical expertise and insight on development and commercial strategies through membership of the Global Project Teams (GPTs) and Brand Launch Teams (BLTs) or Global Brand Teams (GBTS);
Plan and conduct Scientific Advisory Boards with Thought Leaders (TLs) and External Customers;
Represent Leading Pharmaceutical Companys viewpoint on product to Thought Leaders, Scientific Advisors, Health Authorities and to other External
Provide Medical Affairs input to Global Clinical Development Programs;
Provide Medical Affairs input in the determination of probability of success and feasibility;
Provide Medical Review of promotional material from the GBT for global use (e.g. Product Monographs, Brochures, Press Releases, Q&As, and Field Communications);
Provide Medical Affairs leadership pertaining to the Scientific Publication Process, Global Thought Leader Development and Engagement activities and Global Medical Congress Activity;
Provide scientific and Medical Affairs input into core labeling and pharmacovigilance documents for marketed products (e.g. risk management plans and benefit analysis for risk-benefit assessments) and actively contribute to label development and label negotiation process (with Health Authorities);
Establish and Lead Medical Launch Team (MLT) or Medical Steering Team (MST) for the assigned asset(s);
Establish and Lead Medical Affairs Matrix team for Global Brand(s) in Oncology;
Support talent acquisition and development within Medical Affairs and the Oncology SBU.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Leading Pharmaceutical Company seeks an incumbent who possesses the following:
Medical Doctor and/or PhD scientist with advanced post-graduate medical or scientific training experience;
A minimum 5 years of pharmaceutical industry experience in Medical Affairs, Clinical Development or Commercial function of a Global Healthcare Organization or or Regional or Country Pharmaceutical environment;
Disease or Therapeutic area or Scientific knowledge in both existing drugs and new fields of exploration;
Solid understanding of drug development process over different stages;
Understanding of Global regulations and guidelines;
A solid understanding of clinical study design, data analysis and interpretation as well as the principles of observational studies and health economics;
Proven ability to identify and resolve complex problems;
Ability to collaborate with a variety of teams and individuals across functions, cultures and geographies as well as a proven ability to interact effectively with Thought Leaders is strongly preferred;
Effective communicator with a high degree of fluency in written and oral English;
Experience in developing and delivering presesentations.
Experience in effectively managing risk and compliance issues is preferred;
Proven ability to implement successful drug development strategies and programs is preferred
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