Senior Director, Clinical Site Operations

Pfizer, S.A. de C.V; New York (NY); Remote; USD 204,000 - 342,000; Full time

Job summary

A leading global biopharmaceutical company is seeking a Senior Director of Clinical Site Operations to oversee multifaceted strategic initiatives. This role, based in New York, emphasizes managing significant trial operations while guiding diverse teams and collaborating globally. Ideal candidates will have extensive experience and demonstrated leadership capabilities to influence the clinical development landscape.

Benefits

401(k) plan with matching contributions

Paid vacation, holiday, and personal days

Health benefits including dental and vision coverage

Paid caregiver and parental leave

Participation in share-based long term incentive program

Qualifications

• 12+ years experience with a BA/BS, 10+ years with MBA/MS, 7+ years with PhD/JD, or 5+ years with MD/DVM.
• Experience leading diverse teams in a matrix environment.
• Understanding of HR procedures and policies.

Responsibilities

• Accountable for site management and oversight of study execution quality.
• Coordinate cross-functionally for study start up and management.
• Drive the end-to-end connection of stakeholders across portfolios.

Skills

Leadership

Risk Management

Adaptive Management

Team Management

Influencing Skills

Education

BA/BS

MBA/MS

PhD/JD

MD/DVM

Job description

Senior Director, Clinical Site Operations

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

The Senior Director, Clinical Site Operations (DCSO) works above Country/Cluster/Region, Area, and Department to sponsor, chair, or lead operational /strategic lines, in addition to significant strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity.

This Senior DCSO position will lead Monitoring (CRAs) for Oncology in the US. They will influences top management decisions that impact business directives.

The Senior DCSO builds and leverages constructive relationships externally and cross-functional internally. Influence regulatory authority or leading/contribute significantly in industry Clinical Research association and/or drive strategic initiative and innovative methodology implementation across Global Business Units.

They will act as a significant Subject Matter Expert of the principles, concepts, and theories in an assigned discipline and represents the Enterprise to influence direct business drivers associated.

They may serve as delegate to the Area Head for certain key activities, initiatives, and deliverables.

ROLE RESPONSIBILITIES:

• The Senior Director, Clinical Site Operations (Senior DCSO) is accountable for ensuring appropriate Site Care Partner (SCP), as well as Site Monitor resources are in place to deliver on, country and site-level end to end study start up, management and monitoring activities in-line with study milestones in the designated countries/clusters/regions, as well as providing line management and overseeing the job function of the Site Care Partner and Site Monitor.
• The role is also accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
• This is a strategic role that coordinates cross functionally with others in Study Start Up( Start Up Project Management (SUPM),Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)) , Operational Analytics and Quantitative Sciences (OAQS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their cluster when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start up, management and monitoring activities.
• The Senior Director of Clinical Site Operations represents Pfizer Research & Development (PRD) as the in- country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.
• This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders. Applicable to certain countries/clusters/regions, the role also represents site operations in therapeutic area/asset/study-level discussions, working in coordination with other key PRD roles, including but not limited to, Clinician, Directors of Study Management and Clinical Study Team Leads.
• The Senior DirectorofClinicalSiteOperationswill lead, contributeto,andimplementstrategicinitiativesasarepresentativeofthe GSSOLeadership . They will also lead initiatives that shape the clinical development environment within their country/cluster/region to facilitate Pfizer’s clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, activate participates in local industry forums, builds portfolio-aligned, investigational sites/network relationships . To shape performance of ethical clinical research, as needed (e.g., DCT readiness/ virtual monitoring, and drive the cycle times reduction).
• The Senior DirectorofClinicalSiteOperationsprovidesinsightsonlocal/regionaltrendstofacilitatetheconductofclinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial’sconduct.

QUALIFICATIONS:

• BA/BS with at least 12 years of experience or MBA/MS with at least 10 years of experience or PhD/JD with at least 7 years of experience or MD/DVM with at least 5 years of experience
• Ability to lead and manage diverse teams
• Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities
• Ability to leadand influence in a matrix environment, capable of driving initiatives across GSSO
• Demonstrated understanding of HR procedure and policies at global and local level
• Ability to work effectively with line support functions including finance, HR across the region
• Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed
• Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment:Remote

The annual base salary for this position ranges from $204,700.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Role Summary:

The Senior Director, Clinical Site Operations (DCSO) works above Country/Cluster/Region, Area, and Department to sponsor, chair, or lead operational /strategic lines, in addition to significant strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity.

This Senior DCSO position will lead Monitoring (CRAs) for Oncology in the US. They will influences top management decisions that impact business directives.

The Senior DCSO builds and leverages constructive relationships externally and cross-functional internally. Influence regulatory authority or leading/contribute significantly in industry Clinical Research association and/or drive strategic initiative and innovative methodology implementation across Global Business Units.

They will act as a significant Subject Matter Expert of the principles, concepts, and theories in an assigned discipline and represents the Enterprise to influence direct business drivers associated.

They may serve as delegate to the Area Head for certain key activities, initiatives, and deliverables.

ROLE RESPONSIBILITIES:

• The Senior Director, Clinical Site Operations (Senior DCSO) is accountable for ensuring appropriate Site Care Partner (SCP), as well as Site Monitor resources are in place to deliver on, country and site-level end to end study start up, management and monitoring activities in-line with study milestones in the designated countries/clusters/regions, as well as providing line management and overseeing the job function of the Site Care Partner and Site Monitor.
• The role is also accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
• This is a strategic role that coordinates cross functionally with others in Study Start Up( Start Up Project Management (SUPM),Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)) , Operational Analytics and Quantitative Sciences (OAQS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their cluster when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start up, management and monitoring activities.
• The Senior Director of Clinical Site Operations represents Pfizer Research & Development (PRD) as the in- country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.
• This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders. Applicable to certain countries/clusters/regions, the role also represents site operations in therapeutic area/asset/study-level discussions, working in coordination with other key PRD roles, including but not limited to, Clinician, Directors of Study Management and Clinical Study Team Leads.
• The Senior DirectorofClinicalSiteOperationswill lead, contributeto,andimplementstrategicinitiativesasarepresentativeofthe GSSOLeadership . They will also lead initiatives that shape the clinical development environment within their country/cluster/region to facilitate Pfizer’s clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, activate participates in local industry forums, builds portfolio-aligned, investigational sites/network relationships . To shape performance of ethical clinical research, as needed (e.g., DCT readiness/ virtual monitoring, and drive the cycle times reduction).
• The Senior DirectorofClinicalSiteOperationsprovidesinsightsonlocal/regionaltrendstofacilitatetheconductofclinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial’sconduct.

QUALIFICATIONS:

• BA/BS with at least 12 years of experience or MBA/MS with at least 10 years of experience or PhD/JD with at least 7 years of experience or MD/DVM with at least 5 years of experience
• People management experience
• Ability to lead and manage diverse teams
• Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities
• Ability to leadand influence in a matrix environment, capable of driving initiatives across GSSO
• Demonstrated understanding of HR procedure and policies at global and local level
• Ability to work effectively with line support functions including finance, HR across the region
• Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed
• Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment:Remote

The annual base salary for this position ranges from $204,700.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Medical