Associate Director, Clinical Pharmacology Operations Manager, Global Clinical Strategy & Operations

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Job Title - Associate Director, Clinical Pharmacology Operations Manager Division Global Clinical Trial Strategy & Operations within Global Development Operations (GDO)

Position Summary / Objective

The Clinical Pharmacology Operations Manager (CPOM) supports cross functional roles to drive the timely execution of clinical pharmacology trials across a portfolio. As a Subject Matter Expert the role demonstrates expertise within a portfolio and demonstrates strategic alignment across CROs, and issues resolution across trials. This role reports to the Head, Global Clinical Trial Management.

Position Responsibilities

• In partnership with the OPL, supports the development of Clinical Pharmacology study timelines and priorities of studies to support regulatory expectations and asset development objectives
• Monitor work with CROs/external vendors to ensure compliance with agreed protocols, quality standards and timelines.
• Accountable for ePlan and book of work data reconciliation between strategic operations/OPL, development teams, and trial management/GTM.
• Supports the identification of vendors for CP studies. Monthly vendor and outsourcing management data gathering, CRO recommendation and forward planning, and providing supporting rationale for CRO selection based on portfolio knowledge and trends.
• Responsible for executing Clinical Pharmacology (CP) operations strategy; CP and Phase 1 protocol design commentary, planning and risk mitigation against scope and analysis of Phase 1-4 CP studies.
• Anticipates and leads program level issue resolution. Identifies opportunities and leads teams for process improvement initiatives.
• Connects scientific and business implications from multiple teams (both internal and external) and links to overall strategy.
• Develops productive collaborations and communications with other groups across multiple disciplines. Serves as liaison to other departments/divisions for representing the CP Ops mandates/processes/designs.
• Provides internal and external operational oversight of Phase 1 CP studies to ensure data quality and fidelity. Manages one or more CP programs.
• Collaboratively participates in risk assessment and development of contingency plans with internal and external teams.

Degree Requirements Minimum BS Or BA Degree Experience Requirements

• Experience with CRO/vendor management and selection
• > 8 yrs. of relevant industry experience
• Demonstrated logistical sample management skills
• Demonstrated experience in pharmaceutical project management including operational aspects of a clinical study including development of timelines, budgets, resource plans, and risk management

Key Competency Requirements

• Strong knowledge of clinical trial regulations and requirements
• Strong project management and organizational skills
• Strong interpersonal and influencing skills in working with various stakeholders on the study team
• An ability to monitor protocol progress and identify and address issues and risks
• Highly effective oral and written communication skills to influence, inform or guide others.

Travel Required 1-3 times per year

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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