ISR 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.
SR Protocol 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.
⦁ Desired: Strong experience in the cardiovascular therapeutic area and experience with cardiovascular studies.
⦁ Manages complex and varied study types across a matrix organization.
⦁ Familiar with clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, 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.
⦁ Experience in managing clinical components of vendor support and acts as a central point of contact for communication between the team and the external partners (e.g., CRO, networks, alliance partners etc.). Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables. Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.
⦁ 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 Monitor/Study Director, 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 GCPs, 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.
⦁ 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.