Director, Head of Clinical Operations

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The Head of Clinical Operations HCO is accountable for the delivery of all clinical trials for their assigned territory. This role will lead the head country of France plus other countries making up the cluster region for clinical operations. The HCO will lead the team for the assigned territory/region and is responsible for overseeing all elements of delivery related to site management and monitoring of clinical trials across the BMS R&D portfolio.

Reporting to the Regional Head of Clinical Operations this role is a key member of the RCO and GDO extended leadership teams as well as serving as a member of the local affiliate leadership team and affiliate leadership committees (where applicable).

Key Responsibilities

• Accountable for France and associate region level execution strategy and delivery of all portfolio commitments
• Lead a multi-national team of clinical operations professionals providing strategic and operational leadership for site management monitoring and oversight of clinical trials conducted within the assigned territory
• Provide clear direction within the cluster to successfully deliver clinical trials across all phases of development and Therapeutic Areas ensuring adherence to agreed timelines and required quality and cost parameters
• Build and maintain a high performing team through hiring talent ongoing feedback coaching and career development including actively engaging with team members to maximize their potential and support retention of talent
• Strategically assess demand and priorities within the cluster ensuring resource optimization of the team to deliver to committed clinical trial targets and where needed initiate appropriate actions in response to changes in priorities
• Budget and resource management for the cluster
• Approving key operational delivery elements for the cluster including country site and enrolment targets
• Goal setting for the cluster including ongoing evaluation of progress against committed milestones
• Support the proactive identification of improvement areas and contribute to continuous refinement of processes systems and strategies to support the ongoing evolution of GDO and RCO
• Input into global regional and country-level initiatives to ensure regional considerations and operational implications are captured and considered
• Adopt an enterprise perspective to decision making considering the benefits to the wider organization in addition to the cluster/function and support BMS to maintain a competitive industry advantage
• Develop and maintain productive working relationships with key cross-functional stakeholders with the ability to leverage insights effectively express views and influence across different levels of the organization.
• Maintain a thorough understanding of the local regulatory environment within the region providing direction and guidance to support optimal trial delivery
• Represent the company in key interactions with key external partners including industry bodies investigators and site staff local authorities as needed
• Represents RCO and GDO within the affiliate level leadership
• Leads communication within the affiliate regarding BMS clinical trial strategy
• Provide support during preparation and conduct of quality audits and regulatory inspections as needed
• Develop and promote a workplace culture that values diversity of thought promotes integrity and creates an atmosphere that supports coaching and fosters accountability

Qualifications & Experience
Degree Requirements

• Bachelors degree required with an advanced degree preferred.

Experience Requirements

• Extensive relevant industry experience with experience in the management of staff in a pharmaceutical and/or biotechnology environment
• Significant experience in the delivery of global clinical trials in a variety of operating models (internal and outsourced delivery); with proven success in the delivery of clinical operations and the ability to translate science into robust operational delivery plans
• A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena
• Knowledgeable of global regulatory requirements and ICH GCP principles as they relate to clinical trial execution and impact to the business supporting clinical trial execution
• Extensive understanding and experience of the environment in the assigned territory

Key Competency Requirements

• Strong leadership capabilities with a proven ability to engage manage develop and inspire a geographically diverse team
• Demonstrated agility adaptability comfort with ambiguity and a growth mindset
• Strong communication skills including written oral and presentation skills
• Experience leading in a matrix environment prioritizing tasks meeting deadlines and managing multiple and changing demands.
• Ability to collaborate cross-functionally with strong influencing and networking skills to establish and maintain strong internal and external relationships
• In-depth knowledge of clinical operations across the full development lifecycle including monitoring methodologies systems regulations and compliance obligations budget and resource management and interactions with investigator sites

Language Competence : Business Proficiency in both English and French required

Travel Requirements

• 10% to 20% of travel required