Associate Director, Clinical Project Scientist

Description

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

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.

The Associate Director, Clinical Project Scientist, in the US Hematology Medical Affairs organization will be responsible for implementation of Investigator Initiated Studies (IIS), collaborative group studies, and company sponsored studies (CSS), including both interventional and registry studies.  In this role, the individual will be required to work in collaboration with US Hematology Medical Affairs Oncology teams as well as Global Development partners to review submitted IIS/collaborative proposals and execute, track, manage and oversee approved IIS/collaborative protocols.  In support of company sponsored studies, the candidate must ensure timely and compliant execution of the studies in partnership with functional leads. The focus of this candidate is to ensure appropriate execution to deliver data that will support evidence generation needs in the US.  Additionally, candidate will act as point of contact with external Investigators and collaborative groups for protocol intake and review, contract/budget negotiations, track clinical supply demand, manage protocol deliverables, including data generation activities (study reports, manuscripts, congress publications).  This candidate will also lead a CPS team with people leadership responsibilities.

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 cross-functional 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 cross-functional teams is required.
• Able to think creatively, critically, and proactively, with strong problem-solving 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 10 - 15% travel.

The anticipated base pay range for this position is $135,000 to $232,300.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

https://www.careers.jnj.com/employee-benefits

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit  www.careers.jnj.com .