Johnson & Johnson Careers
Director, Clinical Operations
Requisition ID: 6463190606
The Director, Clinical Operations role is a key interface role accountable to the therapeutic area leadership working across multiple therapeutic areas. The Director, Clinical Operations in collaboration with various medical affairs operational counterparts and GCDO will ensure therapeutic strategy development and the clinical and operational implementation of company sponsored studies, investigator-initiated studies and other post marketing research, through insourced, outsourced or matrixed organizations. The individual will focus on Phase IIIB – Phase IV studies, post marketing research and IIS trials to ensure strategic level plans are executed in a timely and compliant fashion for achievement of Medical Affairs’ research goals. In conjunction with program management, manage and be accountable for study and research budgets across the portfolio. Strategically plan and track various research deliverables and projects across Medical Affairs. Review and approve all funding requests for institutional grants and fellowships. Accountability for department contracting. Review and comment on all clinical research specific SOPs/processes and the applicableness to MAF. Supervise Clinical Project Scientist/s, Clinical Operations Associate/s and Grants/Fellowship Manager.
- Responsible for global strategic oversight for multiple therapeutic area products across portfolio for conduct of all Medical Affairs clinical trials/post marketing research and other Clinical Affairs activities.
- Manage the contract development process with third party vendors and/or institutions.
- Strategically align and partner with individuals and groups within and outside Medical Affairs (e.g., GCDO, R&D, GMA, Regulatory Affairs, Clinical Compliance) for critical issues resolution related to clinical and outcomes programs and operations, compliance with training requirements, and audit
- Oversee and approve process for funding requests for grants and fellowships
- Oversee franchise clinical initiatives (program quality, timelines, functional resource allocation in alignment with strategy, clinical processes etc) in collaboration with functional leadership. May lead cross-functional teams for developing and monitoring strategies for clinical process effectiveness.
- Co-manage and be accountable for Medical Affairs financial budgets across entire portfolio, and act as primary liaison with business and finance units for clinical research budgets and third party contract reconciliation.
- Leadership role in the preparation of annual goals & objectives across responsible team; in partnership with Senior Director.
- Bachelors Degree Required
- Advanced Degrees Preferred
- A minimum of 10+ years of clinical research and/or project management experience within the pharmaceutical industry is required, with leadership role in overseeing clinical research and outcomes research programs.
- Strong leadership, interpersonal, and communication skills are required.
- Relevant therapeutic area experience is desired. Experience developing business strategy, and goals & objectives across a portfolio is essential.
- Contracting negotiation experience is desired
- Must be experienced in managing finances (both clinical and administrative) across a portfolio.
- Must demonstrate ability to operate in a matrix environment, and be experienced with cross-functional alliances. Considered by peers as a clinical trials and drug development expert, technically proficient, intelligent, and results oriented.
- Must be a high-performing individual with ability to think creatively, critically, and proactively, with strong problem solving skills.
- Must be able to prioritize, work independently, and have ability to be flexible and manage multiple priorities.
List of Competencies & Skills Required:
- Management or accountability for full Clinical Trial Phase IIIB – IV trials experience required (global experience preferred), IIS experience is desired, minimum of 10+ years of experience.
- Therapeutic area experience desired.
- Financial planning and tracking experience for clinical research activities required.
- Ability to thoroughly review and negotiate contracts with vendors & institutions.
- Experience developing business strategy, including goals & objectives aligned with organizational strategic imperatives.
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.
Janssen Scientific Affairs, LLC (6120)