Bristol-Myers Squibb Company

Sr Clinical Trial Lead - Immunoscience

Location
Princeton, NJ, US
Posted
Nov 05, 2018
Ref
R1114889
Required Education
Doctorate/PHD/MD
Position Type
Full time
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. 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.

We are passionate about our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases and we are looking for talent that shares that passion to join our team. We need drivers who want to progress the science across a tightly integrated continuum of discovery, translational medicine, development and commercial. We work as a nimble team, making fast, informed decisions because today, the science is moving faster than ever before and we are determined to leverage every advancement to get medicines to our patients when they need.

This position is based in Lawrenceville, New Jersey.

Job Description:

The successful candidate will provide expert clinical input to the therapeutic area from discovery through early clinical development, registration and lifecycle management.

Will be a 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.

Review and interpret clinical data, and guide appropriate recommendations and decisions on drug candidates under investigation.

Will contribute to strategic discussions on asset advancement and decision-making as data accrue.

Other responsibilities include contributions to the writing and review of responses and reports submitted to regulatory agencies, identifying and building relationships with thought leaders and investigators, and gathering input on disease areas and design of clinical programs.

Qualifications:

Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. Therapeutic background flexible, but rheumatology, gastroenterology, CV, inflammation/immunology and/or autoimmune disease background are preferred

Experience in designing and executing clinical trials

Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results

Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements

Experience with heath authorities and regulatory submissions

Comfortable working in a fast-paced environment where speed is paramount

Willing to work outside of a traditional functional environment, in a team unified around serving the assets

Ability to recognize, articulate, and accept calculated risks to make informed decisions

Willingness and ability to form strong, productive partnerships with external providers

The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.

Requirements:

• Minimum 5 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