Bristol-Myers Squibb Company

Lead, Clinical Data Analytics Innovation

Location
Hopewell, NJ, US
Posted
Apr 26, 2018
Ref
R1505945
Discipline
Clinical, Clinical Data
Required Education
Doctorate/PHD/MD
Position Type
Full time
The vision of Bristol-Myers Squibb (BMS) is to develop and execute rigorous and innovative pharmacovigilance (PV) and risk management strategies to enable patients to benefit maximally from BMS' products. This will be achieved by advancing the science of drug safety and nurturing an unmatched culture of employee engagement and commitment.

The BMS portfolio has evolved in recent years to focus on specialty medicines to treat conditions with substantial unmet need. Development advances, which are increasingly reliant on translational medicine, biomarkers, and innovative biology, have resulted in a number of breakthrough medicines. However, these advances have also brought new, challenging safety-related issues in the context of ever-evolving regulatory requirements. In order to create and sustain an operational model focused on PV scientific excellence, there is a need to advance capabilities in the analysis of clinical trial data to enable the rigorous, timely, scientific-founded evaluation of safety-related issues. As a department, Global Pharmacovigilance and Epidemiology (GPVE) will need to focus on understanding the fundamental mechanisms of disease, developing state of the art safety-science evaluative strategies, fostering close inter-departmental collaboration, and applying advances in safety analytics to identify, evaluate, and mitigate safety-related issues.

Responsibilities:

The Lead, ESSA Safety Data Analytics Innovation will serve as a cross-functional leader in the development and application of innovative clinical analytic capabilities to support GPVE as follows:
• Strengthen, enhance and integrate cross-matrix capabilities across the department in the following areas:
o Clinical signal detection and evaluation - through development of innovative, transformative solutions (tools and methods) in conjunction with other functional experts in epidemiology, safety science, and analytics and application of these solutions to safety-related issues.
o Integration of data from translational medicine and biomarkers - to increase our fundamental understanding of safety-related issues through innovative predictive modelling techniques.
• Foster and tighten the collaboration and processes between GPVE, Integrated Oncology and Innovative Medicines Development organizations, Global Biometric Sciences, Clinical Pharmacology and Pharmacometrics, Translational Medicine, Medicine, Information Technology, WW Health Economics and Outcomes Research, Business Insights and Analytics, and other relevant functions. This role will focus on leveraging knowledge and analytic methods from other disciplines to increase the speed of innovation in GPVE.
• Develop new analytical methods to address the clinical safety evaluation challenges associated with combination therapies.
• Ensure that data access is optimized across multiple data platforms to allow for meaningful, integrated aggregate analysis.
• Integrate clinical and analytical expertise to contribute to the delivery of the highest quality methods to address specific, key safety-related issues across the development portfolio in close connectivity to all MSAPs and MSTs.
• Work with key stakeholders to evaluate and optimize the presentation of safety evidence during informal and formal discussions and facilitate decision-making by the Medical Safety Assessment Physicians (MSAPs), Medical Surveillance Teams (MSTs), and senior leadership. This will include ad-hoc query of datasets, presentation of data evaluation and analysis plans, as appropriate.

The Lead, ESSA Data Analytics Innovation, will report directly to the Head of ESSA, and will be a member of the ESSA Leadership Team. As BMS aspires to have a non-hierarchical, nimble, collaborative, and innovative culture, this individual should expect to have opportunities to take on responsibilities beyond the stated scope of the position and work closely with key stakeholders across the department and the company to implement innovative analytical strategies for signal detection and safety assessment.

Qualifications:

- MD with completion of clinical residency required. PhD/MPH in epidemiology, statistics, or data science is required.

- Pharmaceutical industry experience greater than 10 years required. Experience and deep knowledge in the areas of safety evaluation, clinical trial design/execution, epidemiologic and analytic methods are required. Mechanistic understanding of biomarkers, translational medicine, pharmacology, and toxicology preferred.

- Demonstrated ability and experience leading high-performing teams in a highly matrixed, collaborative environment. Early and full development experience required. International market experience highly preferred. Capable of influencing in a complex matrixed environment and role modeling these behaviors for employees.

- Must have demonstrated proficiency in authorship and review of the full range of regulatory safety documents such as Clinical Overviews, Summaries of Clinical Safety, Development Safety - Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Investigator Brochures (IB), and post-authorization safety studies (PASS).

- Energized by the BMS vision for PV as a science-based function working as a trusted partner across the company to influence product discovery, development, and commercialization choices. Capable of significant contribution to the realization of this vision.