Director, Head of Clinical Operations
Bristol-Myers Squibb
Director, Head of Clinical Operations
Job Description
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 Bachelor's degree required with an advanced degree preferred. 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 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 10% to 20% of travel required
About the Role/Company
- The company operates in the pharmaceutical and/or biotechnology industry
- The role involves working within the Global Development Operations (GDO) and Regional Clinical Operations (RCO) departments
- The company values diversity of thought, promotes integrity, and supports coaching and fosters accountability
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
- Provide 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
- Ensure 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
- Actively engage with team members to maximize their potential and support retention of talent
- Strategically assess demand and priorities within the cluster
- Ensure resource optimization of the team to deliver to committed clinical trial targets
- Initiate appropriate actions in response to changes in priorities
- Manage budget and resources for the cluster
- Approve key operational delivery elements for the cluster, including country site and enrolment targets
- Set goals for the cluster, including ongoing evaluation of progress against committed milestones
- Support the proactive identification of improvement areas
- 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
- Support BMS to maintain a competitive industry advantage
- Develop and maintain productive working relationships with key cross-functional stakeholders
- 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
- Provide 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
- Represent RCO and GDO within the affiliate level leadership
- Lead 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
Required Qualifications
- Bachelor's degree required
- Extensive relevant industry experience
- 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)
- Proven success in the delivery of clinical operations
- Ability to translate science into robust operational delivery plans
- Strong understanding of the drug development process
- Proven expertise in clinical trial execution and management in a global arena
- Knowledgeable of global regulatory requirements and ICH GCP principles
- Extensive understanding and experience of the environment in the assigned territory
- 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
- 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
Preferred Qualifications
- Advanced degree preferred
Skills Required
- Strong leadership capabilities
- 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
- Ability to collaborate cross-functionally
- Strong influencing and networking skills
- Ability to establish and maintain strong internal and external relationships
Additional Requirements
- 0% to 20% of travel required
Locations
- Rueil Malmaison, France
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership capabilitiesintermediate
- Proven ability to engage, manage, develop, and inspire a geographically diverse teamintermediate
- Demonstrated agility, adaptability, comfort with ambiguity, and a growth mindsetintermediate
- Strong communication skills, including written, oral and presentation skillsintermediate
- Ability to collaborate cross-functionallyintermediate
- Strong influencing and networking skillsintermediate
- Ability to establish and maintain strong internal and external relationshipsintermediate
Required Qualifications
- Bachelor's degree required (experience)
- Extensive relevant industry experience (experience)
- Experience in the management of staff in a pharmaceutical and/or biotechnology environment (experience)
- Significant experience in the delivery of global clinical trials in a variety of operating models (internal and outsourced delivery) (experience)
- Proven success in the delivery of clinical operations (experience)
- Ability to translate science into robust operational delivery plans (experience)
- Strong understanding of the drug development process (experience)
- Proven expertise in clinical trial execution and management in a global arena (experience)
- Knowledgeable of global regulatory requirements and ICH GCP principles (experience)
- Extensive understanding and experience of the environment in the assigned territory (experience)
- Strong leadership capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team (experience)
- Demonstrated agility, adaptability, comfort with ambiguity, and a growth mindset (experience)
- Strong communication skills, including written, oral and presentation skills (experience)
- Experience leading in a matrix environment, prioritizing tasks, meeting deadlines, and managing multiple and changing demands (experience)
- Ability to collaborate cross-functionally, with strong influencing and networking skills (experience)
- 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 (experience)
Preferred Qualifications
- Advanced degree preferred (experience)
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
- Provide 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
- Ensure 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
- Actively engage with team members to maximize their potential and support retention of talent
- Strategically assess demand and priorities within the cluster
- Ensure resource optimization of the team to deliver to committed clinical trial targets
- Initiate appropriate actions in response to changes in priorities
- Manage budget and resources for the cluster
- Approve key operational delivery elements for the cluster, including country site and enrolment targets
- Set goals for the cluster, including ongoing evaluation of progress against committed milestones
- Support the proactive identification of improvement areas
- 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
- Support BMS to maintain a competitive industry advantage
- Develop and maintain productive working relationships with key cross-functional stakeholders
- 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
- Provide 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
- Represent RCO and GDO within the affiliate level leadership
- Lead 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
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Director, Head of Clinical Operations
Bristol-Myers Squibb
Director, Head of Clinical Operations
Job Description
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 Bachelor's degree required with an advanced degree preferred. 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 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 10% to 20% of travel required
About the Role/Company
- The company operates in the pharmaceutical and/or biotechnology industry
- The role involves working within the Global Development Operations (GDO) and Regional Clinical Operations (RCO) departments
- The company values diversity of thought, promotes integrity, and supports coaching and fosters accountability
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
- Provide 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
- Ensure 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
- Actively engage with team members to maximize their potential and support retention of talent
- Strategically assess demand and priorities within the cluster
- Ensure resource optimization of the team to deliver to committed clinical trial targets
- Initiate appropriate actions in response to changes in priorities
- Manage budget and resources for the cluster
- Approve key operational delivery elements for the cluster, including country site and enrolment targets
- Set goals for the cluster, including ongoing evaluation of progress against committed milestones
- Support the proactive identification of improvement areas
- 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
- Support BMS to maintain a competitive industry advantage
- Develop and maintain productive working relationships with key cross-functional stakeholders
- 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
- Provide 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
- Represent RCO and GDO within the affiliate level leadership
- Lead 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
Required Qualifications
- Bachelor's degree required
- Extensive relevant industry experience
- 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)
- Proven success in the delivery of clinical operations
- Ability to translate science into robust operational delivery plans
- Strong understanding of the drug development process
- Proven expertise in clinical trial execution and management in a global arena
- Knowledgeable of global regulatory requirements and ICH GCP principles
- Extensive understanding and experience of the environment in the assigned territory
- 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
- 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
Preferred Qualifications
- Advanced degree preferred
Skills Required
- Strong leadership capabilities
- 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
- Ability to collaborate cross-functionally
- Strong influencing and networking skills
- Ability to establish and maintain strong internal and external relationships
Additional Requirements
- 0% to 20% of travel required
Locations
- Rueil Malmaison, France
Salary
Estimated Salary Rangemedium confidence
120,000 - 180,000 EUR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership capabilitiesintermediate
- Proven ability to engage, manage, develop, and inspire a geographically diverse teamintermediate
- Demonstrated agility, adaptability, comfort with ambiguity, and a growth mindsetintermediate
- Strong communication skills, including written, oral and presentation skillsintermediate
- Ability to collaborate cross-functionallyintermediate
- Strong influencing and networking skillsintermediate
- Ability to establish and maintain strong internal and external relationshipsintermediate
Required Qualifications
- Bachelor's degree required (experience)
- Extensive relevant industry experience (experience)
- Experience in the management of staff in a pharmaceutical and/or biotechnology environment (experience)
- Significant experience in the delivery of global clinical trials in a variety of operating models (internal and outsourced delivery) (experience)
- Proven success in the delivery of clinical operations (experience)
- Ability to translate science into robust operational delivery plans (experience)
- Strong understanding of the drug development process (experience)
- Proven expertise in clinical trial execution and management in a global arena (experience)
- Knowledgeable of global regulatory requirements and ICH GCP principles (experience)
- Extensive understanding and experience of the environment in the assigned territory (experience)
- Strong leadership capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team (experience)
- Demonstrated agility, adaptability, comfort with ambiguity, and a growth mindset (experience)
- Strong communication skills, including written, oral and presentation skills (experience)
- Experience leading in a matrix environment, prioritizing tasks, meeting deadlines, and managing multiple and changing demands (experience)
- Ability to collaborate cross-functionally, with strong influencing and networking skills (experience)
- 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 (experience)
Preferred Qualifications
- Advanced degree preferred (experience)
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
- Provide 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
- Ensure 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
- Actively engage with team members to maximize their potential and support retention of talent
- Strategically assess demand and priorities within the cluster
- Ensure resource optimization of the team to deliver to committed clinical trial targets
- Initiate appropriate actions in response to changes in priorities
- Manage budget and resources for the cluster
- Approve key operational delivery elements for the cluster, including country site and enrolment targets
- Set goals for the cluster, including ongoing evaluation of progress against committed milestones
- Support the proactive identification of improvement areas
- 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
- Support BMS to maintain a competitive industry advantage
- Develop and maintain productive working relationships with key cross-functional stakeholders
- 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
- Provide 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
- Represent RCO and GDO within the affiliate level leadership
- Lead 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
Tags & Categories
Answer 10 quick questions to check your fit for Director, Head of Clinical Operations @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs