Janssen Research & Development, LLC, a member the Johnson & Johnson Family of Companies is recruiting for a Medical Affairs Operation (MAO) Collaborative Studies Lead to be located in Titusville, NJ or any other Janssen Research & Development and Janssen Affiliate location Worldwide.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Medical Affairs Operation (MAO) Collaborative Studies Lead will:
• Be accountable for the successful planning, execution and reporting of a portfolio of assigned local, regional and/or global collaborative studies. This includes adequate resource planning and allocation, meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements.
• Act as the single point of end-to-end accountability within GCDO-MAO at the portfolio/program level and has strong leadership accountability to lead high performing teams.
• Serve as the key contact for and manage relationships with global, regional and local Business Partners (e.g. Medical Affairs and R&D), other internal Business Partners, as well as with other enterprise sectors, as applicable.
• Be responsible for leading collaborative assessments with Business Partners and present recommendations to collaborative governance committee.
• Take responsibility for coordinating all activities within GCDO functions, R&D Operations (RDO) and other key subject matter experts [e.g. HealthCare Compliance and Business Integrity (HCBI), Procurement, Legal, Global Medical Safety (GMS)].
• Lead and supervise a team of Global Trial Managers (GTMs), Trial Managers (TMs) and Global Trial Manager Clinical Trial Assistants (GTM-CTA) and ensure consistencies across collaborative studies and leverages synergies and innovative approaches across portfolio/programs.
• Be accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering a diverse work force that works seamlessly in a highly matrixed environment.Qualifications
• A Bachelor’s degree (or equivalent University degree) in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy, or related field) is required
• An advanced degree (e.g., Masters, MBA, MD, PhD) or equivalent University degree is preferred
• A minimum of 10 years of experience in clinical development and/or Medical Affairs is required
• Experience with Investigator Initiated Studies (IIS) and company-sponsored studies is preferred
• Leadership Competencies with a proven track record of global clinical operational experience and/or strong clinical project management experience in biotech, pharma or CRO environment is preferred
• People management experience is strongly preferred
• In-depth knowledge of global regulatory, quality and logistical aspects of global and local clinical trial conduct and oversight is required
• Sound clinical financial acumen and experience with managing budgets is required
• CRO management experience is preferred
• This position will require up to 20% domestic and international travelPrimary Location
United States-New Jersey-TitusvilleOther Locations
North America, Europe/Middle East/Africa, Latin America, Asia PacificOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Coordination