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Associate Director, Project Manager/Clinical Project Manager, Established Products
Titusville, New Jersey
Requisition ID: 8077180404
Janssen Pharmaceuticals, Inc., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, for a combined Program Management Leader (PML)/Clinical Program Management Leader (CPML). This position is part of the Project Management Office (PMO), supporting the Established Products business and is located in Titusville, NJ.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Established Products organization is the steward of optimizing the value of late lifecycle products for patients globally, through investing in innovative life cycle management and effective regulatory/ legal compliance.
Janssen Research & Development, L.L.C. thrives on a diverse company culture, celebrates the uniqueness of our employees and is committed to inclusion. We are proud to be an equal opportunity employer.
The Associate Director, PML/CPML, Established Products; reports to the Director, Established Products PMO Leader (EP PMO Leader), providing leadership of development programs for a portfolio of marketed products in one of the EP portfolios: Neuroscience, Internal Medicine, Oncology, Woman’s Health-Urology, Anti-Infectives and Pain.
In conjunction with the EP Compound Development Team Leader (CDTL), the PML co-leads multiple CDTs, comprised of global colleagues from Clinical, Regulatory Affairs, Medical Affairs, Commercial, Supply Chain and Safety to support product development, optimization and management needs. Depending on the needs of the product, additional business partners would include: GCDO, Finance, Procurement, Quality, Alliance Management/ Business Development, Legal, GCSO and TA CDTs. In addition, PML/CPML is responsible for the CDTs’ proactive contingency planning, and meeting the requirements for Established Products Strategy Council (EPSC) review.
The PML/CPML has a cross-functional operational leadership role for the integration of end-to-end programs for late lifecycle management (LCM) in a matrix organization, with additional alignment with supply chain, commercial, regulatory planning. Programs may include, but not limited to: clinical trials (requiring CPML leadership), supporting emerging markets access needs, Post-Marketing Requirements (PMR) completion, responding to HA actions and submission planning, product simplification, market delisting or Due Diligence and divestment planning.
PML/CPML is responsible for planning, budgeting, execution, risk management and reporting on program strategy, and coordination of activities across working groups.
The CPML is responsible for supporting the, Clinical Leaders (CLs) and GCDO as needed for execution of late stage clinical development programs, Ph III and IV post-marketing commitments and responses to Health Authority actions. Primary duties include Strategic Planning; HA Submission Management; Program Information/Communication; Program Timelines, Resource, Risk and Cost Management.
Working in partnership with the CDTL and the CL, the PML/CPML is expected to achieve the following results:
- Guide the CDT/Clinical Team (CT) to meet or exceed goals by providing global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making.
- Manage CDT/CT/PMT information, documentation and team communications to ensure timely and accurate dissemination of the CDT strategy and operational status throughout the Company. Employ the reporting processes and tools established by the PMO and the Established Products leadership.
- Lead the planning, execution, control, reporting, and close-out of all compound related work across all functions (e.g. integrated program budget, risk, timeline, resource, and stakeholder management). PML is accountable for alignment between functional groups, CROs and EP plans such that forecasted benefits are achieved. Ensure program work is conducted in compliance with company processes and polices.
- In co-development programs, manage and align on cross-company activities and objectives and manage Alliance meetings as a member of the Joint Steering/Development Committee (JDC/ JSC)
- Actively manage development programs to ensure that clinical studies are effective executed and delivered on timeline and budget targets.
- Work with the CDTL to rapidly activate the CDT in response to regulatory authority queries or actions. Establish the CDT/CT strategy for the response with concomitant goals and objectives in alignment with the established organizational objectives.
- Contribute to and coordinate compound/clinical team strategy updates over time; provide context and history to new CDT/CT members/ stakeholders.
- Manage the CDT/CT in a manner that fosters and maintains high performance team culture. Utilize team development best practices and facilitate lessons learned to ensure optimal performance.
- At direction of CDTL or CL, chair meetings and represent the CDT/CT at interdepartmental meetings, governance meetings, co-development partnerships, and external meetings such as HA or advisory meetings.
- A minimum of a Bachelor degree in life sciences or related field is required.
- A Master’s or Postgraduate degree in life sciences is preferred.
- Professional project management certification (PMP) is desirable.
- A minimum 5 years’ pharmaceutical industry experience, in Clinical Operations, Medical Affairs, Business Development, Program Management, Regulatory Affairs or Market Access is required.
- Prior experience as a member of a CDT is strongly preferred.
- Oncology experience is strongly preferred.
- Demonstrated ability to work with multiple compounds in a matrix cross-functional team environment, resolve conflict, prioritize projects, and influence teams without formal authority, is required.
- A minimum 3 years successful experience managing or leading global and/or virtual teams is highly desirable.
- Experience within a matrix organization with record of successful governance body and/or stakeholder management is strongly preferred.
- Experience in planning or managing health authority submissions (eg IND, CTA, NDA, MAA), DMCs or Advisory Boards is highly desirable.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)