Senior Director, Clinical Site Operations

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

Job summary

Pfizer is seeking a Senior Director for Clinical Site Operations to oversee strategic initiatives in the US. This position involves leading a centralized platform team, ensuring regulatory compliance, and managing relationships with healthcare stakeholders. Ideal candidates will have significant experience in leadership and diverse team management.

Benefits

401(k) plan with company matching contributions

Paid vacation and personal days

Medical, dental, and vision coverage

Parental leave policy

Paid caregiver leave

Qualifications

• Demonstrated ability to lead and manage diverse teams.
• Ability to influence in a matrix environment.
• Understanding of HR procedures at global and local levels.

Responsibilities

• Accountable for ensuring proper resources for Site Care Partner and Site Monitor.
• Coordinates cross-functionally with various stakeholders.
• Represents Pfizer in country-level communications and strategic initiatives.

Skills

Leadership

Adaptive Risk Management

Coaching

Education

BA/BS with at least 12 years of experience

MBA/MS with at least 10 years of experience

PhD/JD with at least 7 years of experience

MD/DVM with at least 5 years of experience

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 Centralized Platform Services in the US. This includes the Centralized ICD Team and Audit Coordination. 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 Centralized Platform Services in the US. This includes the Centralized ICD Team and Audit Coordination. 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

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.

“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, 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.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.

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.

With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.

Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.

Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

• Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
• Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
• Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
• And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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