Full Job Description
Janssen Pharmaceuticals, Inc.(Infectious Disease), a member of Johnson & Johnson's Family of Companies, is an organization driven by dedication to product innovation, customer focus and employee and enterprise excellence. We are currently recruiting for a Sr. Director Medical Affairs Leader, Vaccines. This role can be based in Titusville, NJ, Raritan, NJ or Spring House, PA. Learn more about our efforts on vaccines, please find information at https://www.janssen.com/search/site/vaccine.
Our goal is to build on our leadership position in major existing therapeutic categories, while pioneering and taking the lead in new categories. We actively identify and pursue innovative business opportunities. We create partnerships that contribute to mutual success. People are our strength and the source of our growth. We are committed to providing a diverse, dynamic and challenging work environment where associates and their ideas can develop and thrive. Our focus on customers, partners, people and innovation creates sustainable, profitable growth and shareholder value. Our business practices reflect the responsibilities expressed in the Johnson & Johnson Credo.
The Sr. Director, Medical Affairs Leader, Vaccines will:
Develop and implement the US Medical Affairs strategy for the vaccine’s portfolio for the Infectious Diseases operating company, which includes approximately 5 vaccines in clinical development
Create and build-out a medical team, including Communications, Integrated Evidence Team, Medical Science Liaisons and Clinical team to develop overall strategy for product(s) under his/her supervision with a goal to address medical and scientific issues and to ensure the appropriate use of all relevant Janssen products
Lead and partner in interactions with key individual internal stakeholders (i.e., R&D, GMA, V&E, JSA commercial, regulatory and Global leaders as appropriate) to provide input and decision-making into short, medium, and long-range solutions to ensure appropriate data generation and data communication strategies
Lead and guide interactions with external stakeholders (i.e., CDC ACIP, KOLs, Payers) to ensure appropriate strategy for optimal use of Janssen’s vaccines in the US
Oversee the medical team to providing clinical analysis and support for Janssen Vaccines
Provide medical monitoring and medical oversight for company sponsored Medical Affairs led interventional and observational clinical trials
Develop IIS strategy and assess and supervise Investigator Initiated Studies (as appropriate)
Review the development of compliant promotional materials and the training of product representatives
Develop Advisory Board strategy and maintain relationships with external investigators and opinion leaders
Oversee the development of scholarly publications arising from Janssen studies
Direct and lead the development of product monographs and responses to product inquiries in collaboration with Med Info
Additional Responsibilities include:
Collaborate with Global Vaccine Leaders as necessary to ensure US vaccine execution
Develop and lead the implementation of medical strategy for relevant products
Lead indirect team and build future medical team
Identify and Partner with key external experts and thought leaders on identifying scientific gaps and data generation / communication opportunities.
Partner with commercial, Validation & Evidence, and Strategic Customer Group to optimize access for vaccines
Partner and collaborate with global vaccine team to ensure success
A minimum of a Ph.D. or PharmD is required
An MD or a DO is preferred.
Experience in the infectious diseases or vaccines Therapeutic Area is preferred.
A minimum of 15 years of experience (including subspecialty training) is required.
A minimum of 5 years of experience in a relevant position in pharmaceutical industry is required
A demonstrated track record leading highly matrixed, cross-functional work teams or similar experience comprised of high-level managers and executives is preferred
Proven ability to partner cross culturally/regionally is preferred
In-depth knowledge of clinical methodology, clinical data reviews and analysis is preferred. Knowledge and experience in epidemiological studies and real-world evidence is a plus
Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
Experience in developing and managing strategic relationships with medical experts/opinion leaders and other stakeholders (patients, advocacy groups) is required.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House
Janssen Scientific Affairs, LLC (6120)