Senior Global Medical Affairs Leader - H&N Cancer

6085-Janssen Global Services Legal Entity • Raritan, NJ

3d • Onsite

About The Position

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Senior Global Medical Affairs Lead (GMAL) for Head and Neck cancers will be responsible for leading aspects of the optimization for our strategy and launch readiness for our assets in development in H&N cancer and its life cycle management strategies. The focus of the H&N sGMAL will be on amivantamab’s upcoming indications in HNSCC, and he/she will be responsible for the overall strategy, as well as early pipeline in H&N. As the leader of the WWMAST (Worldwide Medical Affairs Strategy team), the sGMAL will work with the Regional Medical Affairs Leaders in addressing data gaps and building confidence to ensure the most optimal and safe use of and maximize the benefit for patients. A key component of the role of the H&N sGMAL will be providing input on the unmet need and clinical impact expected from future indications, and data gaps associated with it. The sGMAL will partner closely with the GMA Operations Leader, Marketing and Market access leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans. The sGMAL will partner with the regions and the extended medical affairs partners for the development of the global Medical Affairs Strategic plan (WWMAS) that reflects the medical strategy and prioritized needs. In addition, the WWMAST, led by the sGMAL will develop the Integrated Evidence Generation plan, Global Publication plans, Global Opinion Leader relations, Global Medical Education plans and Content, and will be in charge of an overall strategy for optimal Insights gathering. The sGMAL partner with the Global Commercial and Market Access Leads to develop the Global asset plan and be part of the Global Commercial Team (GCT), and Evidence & Medical Access Team. The sGMAL will represent Medical affairs for H&N at the Compound Development Team for amivantamab, which is the key strategic cross-functional team in charge of the overall strategy and life cycle of the product. Other key partners of the sGMAL include clinical development, safety, stat, coms patients advocacy, etc. as well as sGMAL for Lung and CRC. The sGMAL is responsible to ensure all global activities follow J&J Compliance principles, e.g. Health Care Compliance, etc.

Requirements

• MD, PhD or PharmD with experience in oncology with a strong preference for H&N cancer experience.
• A minimum of 8-9 years of combined relevant experience in a medical/clinical environment, scientific function in the pharmaceutical industry is required.
• Prior experience in a country medical affairs role, ideally US, and 3+ years in a global role.
• In-depth knowledge of drug development, study methodology, study data reviews and analysis, and regulatory environment.
• Knowledge of study execution, benefit risk management and lifecycle management
• Understanding of the Healthcare EcoSystem and Evolving environment
• Experience working within and contributing to highly matrixed, cross-functional work teams comprised of high-level managers and executives is required.
• Experience building business cases and working with R&D teams.
• Global mindset required, ability to partner cross culturally/regionally is preferred
• Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the therapeutic area.
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders.
• Excellent Communication skills are required, including executive communication
• Business acumen
• Enterprise mindset and ability to work with a cross functional team toward a common goal, helping patients in need
• Strategic partner and ability to prioritize
• Collaborative mindset, strong experience working across functional teams, countries and regions and culture

Nice To Haves

• H&N cancer experience
• Global role experience
• Ability to partner cross culturally/regionally
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders

Responsibilities

• Leading aspects of the optimization for our strategy and launch readiness for our assets in development in H&N cancer and its life cycle management strategies.
• Responsible for the overall strategy, as well as early pipeline in H&N.
• Leading the WWMAST (Worldwide Medical Affairs Strategy team).
• Working with the Regional Medical Affairs Leaders in addressing data gaps and building confidence to ensure the most optimal and safe use of and maximize the benefit for patients.
• Providing input on the unmet need and clinical impact expected from future indications, and data gaps associated with it.
• Partnering closely with the GMA Operations Leader, Marketing and Market access leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
• Partnering with the regions and the extended medical affairs partners for the development of the global Medical Affairs Strategic plan (WWMAS) that reflects the medical strategy and prioritized needs.
• Developing the Integrated Evidence Generation plan, Global Publication plans, Global Opinion Leader relations, Global Medical Education plans and Content.
• Being in charge of an overall strategy for optimal Insights gathering.
• Partnering with the Global Commercial and Market Access Leads to develop the Global asset plan and be part of the Global Commercial Team (GCT), and Evidence & Medical Access Team.
• Representing Medical affairs for H&N at the Compound Development Team for amivantamab.
• Ensuring all global activities follow J&J Compliance principles, e.g. Health Care Compliance, etc.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• consolidated retirement plan (pension) and savings plan (401(k)).
• long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Time off of Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree