Bristol-Myers Squibb Company

Cardiovascular Clinical Trial Lead IMD Development

Location
Princeton, NJ, US
Posted
Jul 11, 2018
Ref
R1507268
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.

Provide expert clinical input to the cardiovascular area from discovery through early clinical development, registration and lifecycle management.

Description

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

• He/she is 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.

• He/she will review and interpret clinical data, and guide appropriate recommendations and decisions on drug candidates under investigation.

• He/she 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.

This position is based in Lawrenceville, New Jersey

Who We Are

• Small, highly experienced team, significantly leveraging external resources, and working in a radically different way, with the goal of accelerating the creation of transformational medicines for patients

Our Competitive Advantage in achieving greater speed

• Increased efficiency of decision-making and execution

• Ability to source functional resources internally or externally in an agile way

How We Work

• Rapid, portfolio-enhancing, decision-making

• Integrated execution objectives between CFIG and Commercial

• Execute majority of work through strategic partners or BMS functions

• Transparent, flat and collaborative, but not conflict averse working team

• Encouraging in the moment constructive debate

• Effective operating interfaces within BMS and with our Partners

Description

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

• He/she is 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.

• He/she will review and interpret clinical data, and guide appropriate recommendations and decisions on drug candidates under investigation.

• He/she 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.

This position is based in Lawrenceville, New Jersey

Qualifications

Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. A strong cardiovascular medicine background is preferred. Research and development experience and expertise in heart failure therapeutics and cardiac imaging procedures will be valuable.

• Experience in designing and executing clinical trial in either an academic or industry setting.

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

• Understanding of pharmacokinetics, biomarkers, imaging modalities, 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.

Must-haves:

• Strong cardiovascular background as evidenced by cardiology specialty training and / or research and development expertise in cardiovascular medicine.

• Understanding of the clinical development process, and the role of non-R&D functions, including commercial, health outcomes, access, and medical

• Proven ability to partner effectively with key internal and external stakeholders