HireDiversity

Horsham, PA, US

Senior Director Clinical Research, Medical Affairs Strategic Trials Team - Oncology-1341121128

Description

Janssen Services, LLC, a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Director Clinical Research, Medical Affairs Strategic Trials Team, Oncology to be located in Horsham, Pa.

The Medical Affairs Strategic Trials Team (MASTT) is responsible for designing and executing registries, Phase IIIb/IV trials, screening and overseeing Investigator Sponsored studies and other post-marketing requirements within the areas of JBI's current or emerging indications. The research area focus of MASTT includes immunology, oncology and nephrology.

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

The Sr. Director will have direct responsibility for the MASTT group and will oversee Medical Affairs oncology research with ibrutinib, Zytiga (abiraterone), Doxil, and other oncologic agents in late development (i.e. daratumumab). The MASTT team currently includes five Medical Affairs Physicians, two Trialists, two Research Scientists, and four trial operations members.

More specifically, the Sr. Director will be responsible for the strategy leading to the development and execution of Medical Affairs sponsored and supported clinical programs for company products across the JBI therapeutic areas of oncology and immunology. In addition, this individual will serve as a liaison between company and clinical investigators and will develop credible relationships with opinion leaders, medical directors, and key regulatory officials.

The successful candidate will be responsible for medical monitoring and safety reporting activities. Trial conduct and tracking will require close interaction with members of Global Clinical Operations directly responsible for each trial supported by the operating company. A strong working relationship with the JBI Research organization as well as Regulatory Affairs will be essential. The MD/DO within MASTT should be perceived as a peer by clinical research leaders in Oncology Disease areas under research as direct involvement in the interpretation and data display is anticipated.

Essential Functions include: Direct involvement in trial design of Phase IIIb/IV research trials targeting oncologic and nephrologic diseases; Direct supervision of Associate Director and Research Scientist; Collaboration with external investigators and opinion leaders; Directly supervise and monitor trial conduct as well as work closely with other Medical Affairs medical monitor physicians to assure consistency of conduct across trials; Work closely with the clinical project scientist group and GCO to manage trial logistics; Work closely with the project management representative(s) to track trial status; Be prepared to quickly identify trial conduct and logistical problems and provide solutions to rectify the issues as are appropriate; Write as well as provide editorial comments for phase IIIb/IV clinical study reports and manuscripts; Assume the duties and responsibilities of other Therapeutic Area Representative Leads as requested.

J2W:LI

Qualifications


A MD/DO with advanced training and experience in Oncology is required. Board Certification or Board Eligibility in Oncology is preferred. A minimum of 8 years of clinical and managerial experience in pharmaceutical trial design and conduct (Phase II-IV) is required preferably within Oncology. Experience interacting with global regulatory authorities is preferred. Excellent oral and written communication and presentation skills are required for this high visibility position. Demonstrated ability to work in a matrix type environment with interaction with cross-functional teams. Up to 10% travel (domestic and international) is required for this position.

Primary Location:North America-United States-Pennsylvania-Horsham
Organization: Janssen Services, LLC (6114)