Protocol Manager

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.

Summary

NRDGProtocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will provide operational expertise and will focus on studies including Investigator Sponsored Research & other study types. Protocol managers act as a matrix leader for operational support team(s) and are accountable for the timely execution of NRDG trials.

Responsibilities

A GCO NRDGProtocol Manager will provide end-to-end management of Non-Regulatory Data Generation (NRDG) clinical research. They will develop expertise in a disease area (oncology or specialty), and focus on studies including Health Economics and Outcomes Research (HEOR), Investigator-Sponsored Research (ISR), Expanded Access Programs (EAP), Non-Clinical Research (NCR)and some late-stage interventional research. Protocol managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG.

Drive the successful and timely execution of medical-affairs trial work. Including investigator sponsored trials from study start-up, to final study report within the established timelines and budget

Support of the cardiovascular/oncology/immunoscience therapeutic areas and experience with managing these therapeutic areas for Medical affairs trials (eg: HEOR, ISRs, Late Phase).

Manages complex and varied study types across a matrix organization.

Responsible to manage applicable clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality/compliance, timelines and budget are managed according to expectations.

Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team's control. Applies critical thinking to manage complex issues. Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.

As applicable, supports protocol budget negotiations, contracts and other study costs with sites

As applicable, collaborate with regulatory to secure authorization letters to submit to regulatory agencies for IND submissions and/or cross reference letters

Collaborate with Drug Supply to project clinical supply needs based on projected site activation and enrollment

Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables. Creates synergy with stakeholders and develops strong alliances and teamwork with Medical, Operational leadership, field medical, drug supply, and other team members. Effectively leverages network of internal and external contacts.

Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

Strong understanding of GCP, ICH and regulatory guidelines as they apply to protocol management and program strategy.

Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.

Effective oral, written and interpersonal communication skills

Experience withconflict and issue management.

Ability to learn new technology and effectively use Clinical Trial Management Systems (CTMS) and other technology platforms.

Demonstrated ability to multi-task and manage high performance demands.

Qualifications

Minimum education BA/BS required.

Prefer individual with strong science background with a minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO (or equivalent) industry

Prefer individual with a minimum of 5 years of demonstrated NRDG (ISR) experience