Bristol-Myers Squibb Company

Clinical Trial Lead - Orencia

Location
Princeton, NJ, US
Posted
Oct 07, 2018
Ref
R1119739
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.

Job Description:

The Clinical Trial Lead works 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 contributes substantially to regulatory submissions.

Responsibilities:

Works with the Orencia Program Team Lead, the Full Development Team Lead, and matrix team members to translate the Orencia FDT strategy into protocols and action plans.

Works with the relevant leaders to author clinical protocols and related documents, including clinical study reports, clinical regulatory documents including integrated summaries and clinical overviews.

In collaboration with pharmacovigilance, designs and implements safety monitoring plans

Provides key contributions to clinical documents and deliverables in support of regulatory submissions.

Monitors one or more clinical trials for safety and experimental rigor

Reviews and cleans data from clinical trials

Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions

Cultivates relationships with thought leaders and investigators, and gathers input on disease areas and design of clinical programs.

Provides clinical support to medical affairs and commercial colleagues

Qualifications:

MD, PhD, MD/PhD required, preferably with a deep understanding of immunology and autoimmune disease. Expertise in rheumatology or transplant preferred.

At least 10 years of experience in clinical or translational research or in clinical practice in a relevant field, such as rheumatology or transplant.

Understanding of the fundamentals of protocol development and execution, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock.

Able to work consistently in a matrixed environment with relevant teams such as operations, statistics, regulatory, pharmacovigilance and biomarkers.

Able to lead multiple, complex, studies in parallel

Exhibits capable team leadership