Director, Clin Ops & Program Management

Johnson and Johnson Innovative Medicine s recruiting for the Director, Clinical Operations and Program Management, located in Horsham, PA.

This role will be accountable and responsible for planning and execution of medical affairs data generation efforts including clinical and operational implementation of company sponsored studies (CSS), investigator-initiated studies (IIS), collaborative studies, and post marketing commitments. This individual will be the line manager for the Clinical Operations and Program Management teams and will ensure consistent Clinical Project Scientist (CPS) and PM support for key activities in the respective therapeutic area. This person will assist the head of the group in managing the departmental budgets and will be a primary contributor to annual budget planning. Working with the Cross functional team, they will take lead in the development of therapeutic area strategic plans, including the Business Plan (BP). Responsibilities will also include the development & maintenance of critical internal & external alliances for the assigned Therapeutic Area (TA) portfolio.
Key Responsibilities:

• Collaborate with TA Leaders, Integrated Evidence Team Leads (IETL), and other key partners in developing and implementing the strategic imperatives and plans (e.g., Business Plan & Integrated Evidence Generation Plan) to optimize the value of Medical Affairs investments in the assigned TA portfolio.
• Point person for providing leadership as well as financial oversight and budget planning for assigned TA portfolio.
• Play a key role in defining the process and implementing the strategic plan for developing the Monthly Business Review (MBR) presentations.
• Prepare and lead monthly budget review meetings and proactively coordinate financial variability throughout the year.
• Establish core proficiencies of clinical and Program Management to provide optimum support.
• Lead alliances with RWE and external alliances.
• Provide strategic and operational leadership for various data generation activities across various clinical trials and other programs.
• Collaborate with Global Development leaders, including trial and contracting staff, to ensure appropriate support to enable study success within portfolio aligned timelines.
• Support and mentor team to develop talent and achieve overall TA and Medical Group goals.

Education:

• Minimum of bachelor's degree is required.

Experience and Skills:
Required:

• At least ten years of experience in the pharmaceutical industry, including a minimum of eight years in project management and/or clinical operations is required. Proficiency in the Oncology therapeutic area is highly preferred.
• Management of external partnerships and alliances.
• Clinical research and/or project management experience within the pharmaceutical industry is required, with leadership role in coordinating clinical research and outcomes research programs.
• The candidate must be a highly motivated, organized, self-starter with a proven track record of leadership and achievement.
• The candidate should have a demonstrated ability to work efficiently in a matrix environment with cross functional teams.

Preferred:

• Post-graduate degree in life sciences or business management preferred.
• Expert knowledge of the drug development process, including clinical trials
• Strong interpersonal capabilities in linking between scientific and business participants, for negotiating timelines and for effective interactions with all levels of the organization.
• Strong analytical skills for integrating and interpreting interdisciplinary project information.
• Process Excellence Training or Project Management certification preferred.

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.