Bristol-Myers Squibb Company

Worldwide Health Economics & Outcomes Research Asset/Indication Lead- Clinical Outcomes Assessment T

Location
Princeton, NJ, US
Posted
May 12, 2018
Ref
R1503030
Required Education
Doctorate/PHD/MD
Position Type
Full time
The remit of the asset/indication Lead, Clinical Outcomes Assessment Team (COAT) is to promote patient-focused drug development by incorporating patients' and others' subjective perspectives into clinical research through the utilization of COA measures. The incumbent will ensure that endpoint strategies are aligned with product strategic plans from matrix teams to achieve the BMS' vision of patient centricity. He or she will also provide strategic leadership to therapeutic area teams regarding the development of the COA strategy, fitness of assessment measures for intended uses, and regulatory efforts to maximize labeling opportunities.

The COAT is a newly formed team of experts in the measurement of subjective assessments focusing primarily on BMS' oncology franchise. In addition to deriving a patient-centric understanding of relevant conditions, the team will play a key role in measuring, analyzing, and interpreting relevant concepts in a scientifically robust manner using COA measures. The primary focus is on developing, assessing, using, interpreting, and disseminating patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs) to derive treatment benefit during the clinical development of new medicines (Phase 2-4). The team will also a play a key role in disseminating the findings of patient-centric outcomes through scientific journals, regulatory dossiers, and press releases.

Lead COAT including staff recruitment and deployment, development of business practices and SOP, budget and execution, objectives setting and evaluation.

Responsibilities

Promote vision of the COAT throughout the organization.

Continuously improve internal processes to capture COAs in oncology drug development programs.

Identify touch-points in processes and include checklists to aid program leads in deciding on integration of COA measures in programs/studies.

Ensure visibility of the COAT by becoming the "go to" group to ensure optimal integration of COA measures in development programs.

Define best practices relating to the integration of COA measures in drug development.

Identify, track, and participate in global external collaborations regarding policies, standards, and use of COA measures (e.g., PRO Consortium, BIO PFDD Task Force, PRO-CTCAE working group, EuroQol Group, ISPOR working groups).

Participate in creating and delivering education on COA measures for internal business partners.

Provide guidance to direct reports, set objectives, monitor performance, and manage conflicts.

Continuously improve processes for working with vendors and set standards for preferred suppliers to ensure quality and timely deliverables.

Ensure standards are in place for all deliverables.

Requirements

Preference will be given to candidates with a Ph.D. or equivalent degree in a relevant discipline (e.g., psychology, psychometrics, outcomes research, public health) or those who possess a clinical doctorate (M.D., Pharm.D.) coupled with a master's degree. The candidate should possess a minimum of 7 years of related experience (10 or more if highest level of education is master's degree), including a minimum of 5 years of pharmaceutical industry or CRO experience.

Experienced with COA requirements for regulatory and HTA/reimbursement agencies, including understanding of the FDA Patient Reported Outcomes Guidance.

Strong record of publication in COA and success in obtaining regulatory claims from these.

Experience in the development and validation of COA measures.

Understanding of health care markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data.

Understanding of evolving concepts in the development and use COA measures.

Knowledge of the drug development process with immuno-oncology being strongly preferred and some experience in oncology being required.

Technical competency in psychometrics or statistics with ability to translate analytic skill into strategic vision of relevance to internal and external stakeholders.

Excellent interpersonal and communication skills, both written and oral, with ability to engage stakeholders from operations through executive levels.

Ability to work effectively in small teams or independently.

Ability to interact with and manage internal and external networks.