Director of Site Management and Monitoring (DSMM)
Pfizer, S.A. de C.V - New York, New York, us, 10261
Work at Pfizer, S.A. de C.V
Overview
- View job
Overview
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. Supporting Pfizer Oncology, in partnership with the Director of Clinical Site Operations (DCSO), you will ensure appropriate Site Care Partners (SCP) are in place to deliver on, country and site-level end to end study start up, site management and monitoring activities in-line with study milestones for the United States, as well as providing line management and overseeing the job function of the Site Care Partner. You will support the DCSO, who is responsible for ensuring overall operational site management and oversight activities within the United States and supervising the activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards. You will partner 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), Site Monitoring, Optimization, Analytics, and Recruitment Solutions (OARS), 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 the United States when applicable. You will also execute investigator site/recruitment strategies and site-level end to end study start up, site management and monitoring activities. You will also lead, contribute to, and implement strategic initiatives as a representative of the Global Site and Study Operations (GSSO) Leadership. You will also lead initiatives that shape the clinical development environment within the United States to facilitate Pfizer’s clinical development goals and scientific leadership. POSITION RESPONSIBILITIES Line Management of Site Care Partner roles (Team size approximately 15 colleagues and Functional Service Providers-FSP) Lead and coach allocated resources within assigned country/cluster/region. Overall accountability for the Growth and Development of the Site Operations organization Oversee job function as described in the Site Care Partners & Line Manager of SCPs job description and ensure compliance with training requirements. Closely liaise with the FSP Manager of Site Care Partner as described in standard contracts with the FSP organization to oversee FSP SCP roles’. Where required, perform joint site visits with direct reports to assess performance. Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and solid investigator site relationships. Establish consistent direction and priorities across assigned countries/cluster/region. Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes. Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders. Demonstrate Therapy Area expertise, where appropriate. Responsible for timely and quality site start-up including activation. Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient safety in selected investigational sites. Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable. Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed. Drive effective resource management across portfolio for given country to ensure balanced resource allocation for SCP across the Oncology Therapeutic Areas and regions. MINIMUM REQUIREMENTS Relevant PhD and a minimum of 5 years of clinical research experience Relevant Masters degree and a minimum of 7 years of clinical research experience Relevant Bachelors degree and a minimum of 8 years of clinical research experience Extensive knowledge of clinical trial methodologies with experience delivering high quality clinical trials in a multi-national pharmaceutical company and/or clinical research organization. Experience leading and managing people and large, diverse teams in a matrix environment Experience engaging with senior stakeholders internally and externally to the organization. Experience working effectively with line support functions including Finance and People Experience (PX) across the region. Experience managing escalated issues from sites / investigators Availability to travel up to 20% within the country and/or globally as required. Strong learning agility PREFERRED QUALIFICATIONS Understanding of Pfizer People Experience (PX) procedures and policies at global and local level.
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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel within the country and/or globally
Work Location Assignment:Remote The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
POSITION SUMMARY Supporting Pfizer Oncology, in partnership with the Director of Clinical Site Operations (DCSO), you will ensure appropriate Site Care Partners (SCP) are in place to deliver on, country and site-level end to end study start up, site management and monitoring activities in-line with study milestones for the United States, as well as providing line management and overseeing the job function of the Site Care Partner. You will support the DCSO, who is responsible for ensuring overall operational site management and oversight activities within the United States and supervising the activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards. You will partner 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), Site Monitoring, Optimization, Analytics, and Recruitment Solutions (OARS), 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 the United States when applicable. You will also execute investigator site/recruitment strategies and site-level end to end study start up, site management and monitoring activities. You will also lead, contribute to, and implement strategic initiatives as a representative of the Global Site and Study Operations (GSSO) Leadership. You will also lead initiatives that shape the clinical development environment within the United States to facilitate Pfizer’s clinical development goals and scientific leadership. POSITION RESPONSIBILITIES Line Management of Site Care Partner roles (Team size approximately 15 colleagues and Functional Service Providers-FSP)
Lead and coach allocated resources within assigned country/cluster/region.
Overall accountability for the Growth and Development of the Site Operations organization
Oversee job function as described in the Site Care Partners & Line Manager of SCPs job description and ensure compliance with training requirements.
Closely liaise with the FSP Manager of Site Care Partner as described in standard contracts with the FSP organization to oversee FSP SCP roles’.
Where required, perform joint site visits with direct reports to assess performance.
Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and solid investigator site relationships.
Establish consistent direction and priorities across assigned countries/cluster/region.
Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes.
Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
Demonstrate Therapy Area expertise, where appropriate.
Responsible for timely and quality site start-up including activation.
Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient safety in selected investigational sites.
Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable.
Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed.
Drive effective resource management across portfolio for given country to ensure balanced resource allocation for SCP across the Oncology Therapeutic Areas and regions.
MINIMUM REQUIREMENTS Relevant PhD and a minimum of 5 years of clinical research experience
Relevant Masters degree and a minimum of 7 years of clinical research experience
Relevant Bachelors degree and a minimum of 8 years of clinical research experience
Extensive knowledge of clinical trial methodologies with experience delivering high quality clinical trials in a multi-national pharmaceutical company and/or clinical research organization.
Experience leading and managing people and large, diverse teams in a matrix environment
Experience engaging with senior stakeholders internally and externally to the organization.
Experience working effectively with line support functions including Finance and People Experience (PX) across the region.
Experience managing escalated issues from sites / investigators
Availability to travel up to 20% within the country and/or globally as required.
Strong learning agility
PREFERRED QUALIFICATIONS Understanding of Pfizer People Experience (PX) procedures and policies at global and local level.
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. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel within the country and/or globally
Work Location Assignment:Remote The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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#LI-Remote #LI-PFE 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. captions off , selected This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Text Color Transparency Background Background Color Transparency Window Window Color Transparency Font Size Text Edge Style Font Family End of dialog window. This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. This is a modal window. This modal can be closed by pressing the Escape key or activating the close button.
#J-18808-Ljbffr