Associate Director Clinical Operations

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Job Information

Bristol Myers Squibb

Associate Director, Clinical Operations

in

Princeton

New Jersey

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

To lead a cross functional or functional Clinical Operations Unit, ensuring execution to clinical operations effectiveness in RCO UNITED STATES

Key Responsibilities and Major Duties

Direct supervision of line manager(s) within Clinical Operations

May supervise and coordinate the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Associates (CTAs), and/or Study Start-up Specialists to ensure timely execution consistent with R&D and local research goals and priorities

Effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.

Anticipates resource needs and provides workload evaluations and task assignments

Allocates and assign study resources at the cross functional/functional unit level in alignment with R&D and local research goals and priorities.

Supervises clinical trial execution at country level including supervising study metrics and team performance

Approves study fee funds and payments based on grant of authority

May propose and/or validate country study targets

May support Health Authority inspection and pre-inspection activities

May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available

Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met

Together with the Head of Clinical Operations tracks and manages performance metrics for Clinical Operations staff

Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit

May act as a Point of Contact for FSP staff within the country

Managing the hiring, performance management and succession planning of staff

Performing general and human resource administrative functions

Participation in performance calibration and talent review meetings

Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GSR, GPV, Market Access, Commercial, Human Resources)

May represent RCO in local leadership discussions at the affiliate level

Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed

Manage partnerships with critical accounts / sites

Direct line reporting responsibility for Line Managers, CT Mgrs, CTAs, and/or Study Start-up Specialists

Minimum Requirements

Degree/Certification/Licensure

Bachelors or Master’s Degree within life sciences or equivalent

Experience – Responsibility and minimum number of years

A minimum of 10 years Pharmaceutical industry experience in Clinical Research or Medical Affairs including extensive experience in people management

Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)

Demonstrated ability to drive project related activities

Previous experience leading, managing, coaching and developing direct reports

Competencies – knowledge, skills, abilities, other

In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs

In depth knowledge and understanding of clinical research processes, regulations and methodology

Ability to manage and lead complex regional and/or global initiatives

Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management​

Demonstrated organizational and planning skills and independent decision-making ability

Strong organization and time management skills and ability to effectively manage multiple competing priorities

Outstanding interpersonal, oral and written communication skills to influence, inform or guide others

Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance (e.g., Microsoft Suite)

Microsoft Suite

Clinical Trial Management Systems

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com