Janssen Pharmaceuticals, Inc., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Program Management Leader (PML). This position is part of the Program Management Office (PMO), supporting the Established Products (EP) business and is located in Titusville, NJ or Raritan, NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Established Products is the steward of optimizing the value of late lifecycle products for patients globally, through investing in innovative life cycle management and effective regulatory and legal compliance. We thrive on a diverse company culture and is committed to inclusion.
The Associate Director, PML Established Products; reports to the Director, Established Products PMO Leader, providing strategic operational leadership of late lifecycle programs for a portfolio of marketed products in Internal Medicine and Pain.
The PML leads cross-functional delivery of end-to-end lifecycle management (LCM) programs in a matrix organization. LCM programs may include, not limited to:
LTE or BE clinical trials, Post-Marketing Requirements, responding to HA actions, submission planning, supporting emerging markets access needs, regional investment opportunity assessments, strategy development in regards to changing environment (regional/global), market delisting, due diligence and divestment planning. PML is responsible for strategy alignment, project planning, budgeting, execution (cross-functional coordination), risk management and reporting of status and issues.
In conjunction with EP Compound Development Team Leader (CDTL), the PML co-leads multiple CDTs of global colleagues from Clinical, Regulatory, Medical Affairs, Commercial, Supply Chain and Safety. Additional functions (ad hoc) include:
GDO, Finance, Quality, Alliance Management, Business Development, Legal and TA CDTs. The PML is responsible for the portfolio of products end to end project planning, including portfolio impact assessment from product decisions. The PML maintains current project plans, 5-year Product Strategy Position (PSP), reports on the status of major milestones (EP Tracker) and authors the Quarterly Status Report. With the CDTL, PML is responsible for meeting governance requirements established by Established Products Strategy Council (EPSC) for program endorsement.
PML is expected to achieve the following results: Create a prioritized CDT framework that guides the team to meet project goals by facilitating risk and issue resolution/mitigation planning, problem-solving, and decision-making.
Develop and maintain a high-performance team culture. Utilize PMO and Established Products Leadership Team (EPLT) tools for best practices and facilitate lessons learned for optimal performance. Lead the planning, execution, reporting, and close-out of projects across CDT (e.g. integrated program budget, risk, timeline, resources). PML is accountable for alignment between regional and functional groups, to achieve optimal outcomes.
Ensure program work is conducted in compliance with company processes and polices. Lead CDT/Project Management Team (PMT) information, documentation and team communication to ensure timely and dissemination of CDT strategy and status to Senior Leaders. In co-development programs, manage alignment of cross-company activities and objectives, lead Alliance meetings as a member of the Joint Development Committee (JDC) Rapidly activate CDT in response to regulatory authority queries or actions. Proactively plan how CDT will address anticipated related queries.
Minimum of a Bachelor degree in life sciences or related field is required. A Master's or Postgraduate degree in life sciences or MBA is preferred.
Experience and Skills:
A minimum 10 years' pharmaceutical or biotech industry experience in Drug Development, Medical Affairs, Business Development, Program Management, Regulatory Affairs or Market Access is required.
Proven ability to work with multiple compounds in a cross-functional and cross-regional team environment, align product strategy and projects deliverables, and hold team accountability is required.
Ability to resolve conflict, prioritize projects, lead virtually, communicate clearly, and influence teams without formal authority, is required.
Experience within a matrix organization with record of successful project execution and stakeholder management is required.
Minimum 5 years successful experience managing, or leading global and/or virtual teams is highly desirable. Prior experience as a member of a CDT or IBVT, or late lifecycle experience is strongly preferred.
Knowledge of key Health Authority (FDA, EMA, PMDA) processes, submission planning, or preparing for KOL Advisory Board experience is preferred.
A Project Management Institute (PMI) certification (e.g. PMP, CAPM)
May require up to 10% international and domestic travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC (6084)
Johnson & Johnson