Senior Director, Clinical Site Operations

Pfizer; United States; Remote; USD 204,000 - 342,000; Full time

Job summary

A leading pharmaceutical company seeks a Senior Director of Clinical Site Operations to oversee strategic initiatives in patient safety and site management for oncology trials in the U.S. This role requires significant leadership, collaboration, and expertise in clinical research, making critical decisions that influence clinical development strategies. The successful candidate will manage cross-functional teams, ensure compliance with regulations, and drive stakeholder engagement to achieve study objectives.

Benefits

401(k) plan with matching contributions

Paid vacation and personal days

Health benefits including medical, dental, and vision coverage

Relocation assistance may be available

Eligibility for participation in the Global Performance Plan

Qualifications

• At least 12 years of experience for BA/BS; 10 years for MBA/MS; 7 years for PhD/JD; 5 years for MD/DVM.
• Experience in people management and leading diverse teams.
• Ability to lead initiatives across global operations.

Responsibilities

• Accountable for ensuring monitoring and site management activities meet regulatory and company standards.
• Coordinates cross-functionally for study start-up activities and site selection.
• Drives strategic initiatives for improving clinical trial conduct.

Skills

Leadership

Risk Management

Collaboration

Coaching and Development

Education

BA/BS

MBA/MS

PhD/JD

MD/DVM

Job description

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 Director of Clinical Site Operations will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. 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 Director of Clinical Site Operations provides insights on local/regional trends to facilitate the conduct of clinical 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’s conduct.

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