Associate Director, Clinical Project Scientist - Horsham, United States - Johnson & Johnson

Mark Lane

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Mark Lane

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Description
Johnson & Johnson, is recruiting for an Associate Director, Clinical Project Scientist, Oncology to be located in Horsham, PA.

We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.


In this role you will:


  • Oversee and support all aspects of internal review and approval of IIS, collaborative clinical studies and company sponsored studies. May oversee and support other medical affairs activities, such as data safety monitoring board, investigator meetings and steering committees.
  • Collaborate with Investigators, Medical Directors/SRP/SRS, and other business functions (Global Medical Affairs [GMA], Safety, Compliance, supply chain and R&D) to ensure timely execution of IIS, collaborative studies or CSSs
  • Actively contribute to protocol/Informed consent planning and development. Collaborates with TA lead, Medical Directors and counterpart in Global Medical Affairs, as needed, to understand asset strategy and data generation priorities across an asset or number of assets. May include interpretation of results and preparation and/or review of internal/external presentations.
  • Manage monthly/periodic meetings to monitor/ track ongoing status of assigned studies and assist in IIS/collaborative proposal intake, review, and tracking.
  • Collaborate with medical team and Medical Affairs Delivery Unit personnel to assist with execution of clinical studies; interpretation of results; preparation of oral and written internal/external presentations; development, management, and tracking of trial budgets; and budget and contract development with Investigators and, as needed third party vendors.
  • Proactively interface with internal and external stakeholders to resolve contract/budget negotiation issues. Development and implementation of risk mitigation strategies as well as study timeline management.
  • Assist with tracking and managing adverse event data collection across trials (IIS and company sponsored); and where appropriate, incorporation into obligatory regulatory documents. Interface with GCO Safety personnel and Global Medical Safety.
  • Execute and/or oversee franchise clinical initiatives (program quality, tracking against financial targets, timelines, clinical processes, etc.) in collaboration with TA leadership.
  • Lead crossfunctional teams for evaluating new product ideas, implementing franchise business strategies, and/or developing and monitoring strategies for clinical process effectiveness.
  • Ensure compliance with internal J&J SOPs including local and global health authority regulations and guidelines.
  • Manage study and program level budgets, provide budget projection for Business Planning and work with IETL on strategic priorities.
  • Forecast, plan, track and execute on program level drug supply requirements.

Qualifications:


Qualifications:


  • A minimum of a Bachelor's degree is required. Master's or doctoral degree in the life sciences, medical sciences, chemistry, or business advanced degree is preferred; knowledge of Oncology therapeutic area is highly preferred.
  • A minimum of 7 years of experience within the pharmaceutical industry is required with significant experience in supporting and managing IIS/collaborative trials and/or company sponsored studies.
  • Financial acumen is strongly desired.
  • Proven presentation and analytical skills, ability to work efficiently and lead crossfunctional teams is required.
  • Able to think creatively, critically, and proactively, with strong problemsolving skills. Collaborative and flexible in personal interactions at all levels of the company.
  • Previous contract management/negotiation experience is desired.
  • The position will be based in Horsham, PA and may require up to % travel.
The anticipated base pay range for this position is $135,000 to $232,300.


Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Additional information can be found through the link below.

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.


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