Clinical Trial Lead, Marketed Products Development
The Clinical Trial Lead works in partnership with stakeholders across the organization to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives. The Clinical Trial Lead reviews and interprets clinical data, and guides appropriate recommendations and decisions, and also contributes to strategic discussions on asset advancement and decision-making as data accrue.
This position is based in Lawrenceville (Princeton Pike), New Jersey.
Responsibilities: •Provide expert clinical input to the therapeutic area from discovery through early clinical development, registration and lifecycle management.
•Works with Program Team Lead, team members and governance bodies to translate the FDT strategy into protocols and action plans.
•Knowledgeable medical monitor who will partner with development colleagues from CROs to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives.
•Clinical monitoring of studies; review, interpretation and cleansing of clinical data of on-going studies, and guide appropriate recommendations and decisions on drug candidates under investigation; Contribute to strategic discussions on asset advancement and decision-making as data accrue.
• Addresses relevant clinical queries from study sites; and authors/contributes to the writing and review of study-related responses and reports submitted to regulatory agencies.
•Identifies and builds relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.
•Other responsibilities include: ?Works with the relevant leaders to author clinical protocols and related documents ?Design and implementation of safety monitoring plans ?Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
Qualifications: •Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. Therapeutic background flexible, but neurology, CV, vascular medicine, hematology/thrombosis background are preferred. •Experience in designing and executing clinical trials. •Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results •Ability to recognize, articulate, and accept calculated risks to make informed decisions •Deep understanding of the fundamentals of protocol development and follow up, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock •Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements •Comfortable working in a fast-paced environment; ability to support multiple, complex, studies in parallel •Willing to work outside of a traditional functional environment, in a team unified around serving the assets •Willingness and ability to form strong, productive partnerships with external providers/thought leaders •Possess excellent communication skills and experience delivering effective presentations on both technical and non-technical subjects. •Exhibits capable team leadership, ability to work independently and engage others in deliverables
Must-haves: • Minimum 3 yrs of experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage • Experience supervising CRO-driven studies • Experience with health authorities and regulatory submissions • Understanding of the clinical development process, and the role of non-R&D functions: commercial, health outcomes, access, medical • Proven ability to partner effectively with key internal and external stakeholders
Bristol-Myers Squibb is an equal opportunity employer - Minorities/Females/Protected Veterans/Disabled
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and... ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.