Pfizer, S.A. de C.V
Clinical Development Medical, Associate Director
Pfizer, S.A. de C.V, Pearl River, New York, United States, 10965
Clinical Development Medical, Associate Director
United States - New York - Pearl River
United States - Pennsylvania - Collegeville
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.
ROLE SUMMARY The primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for the execution of the overall program. Importantly, this role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.
ROLE RESPONSIBILITIES Accountable for safety across the study
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP). Perform and document regular review of individual subject safety data and review cumulative safety data with the safety risk lead. Delegate these responsibilities to the study clinician scientist identified in the SSRP as appropriate. Detail the components of safety data review in the relevant SOPs and “Safety Data Review Guide – for Clinicians.”
Monitor study safety issues and provide input to serious adverse event (SAE) reports, providing appropriate medical context in terms of risk factors, medical history and other important medical factors.
Participate in the Safety Review Team to evaluate medical benefits/risks for targeted clinical indications.
Review literature as needed to respond to safety questions posed by the Safety Review Team, Data Monitoring Committee (DMC) or other stakeholders.
Communicate safety information to sites across the study and respond to safety questions.
Protocol design and strategy
Contribute medical input during protocol development and updates to the clinical development plan.
Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
Provide medical input into country feasibility.
Support study team
Provide clinical input to protocol and study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
Contribute to contract research organization/vendor selection to ensure the study is conducted consistently with protocol requirements, clinical plan expectations and study timelines, ensuring medical/technical data integrity requirements are applied.
Work with study team to ensure high quality of data, e.g., appropriate patient population, adequacy of clinical assessments during the study.
Contribute to medical review and interpretation of efficacy and safety data, delivering top‑line reports in collaboration with the statistician and clinical study reports with the medical writer, accountable for overall quality and timeliness of analysis and reporting.
Provide protocol‑specific training to study team, investigators, clinical research associates and others.
Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
Interact with DMCs and steering committees as required.
Notify study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
Monitor investigator compliance with protocol and regulatory requirements.
Support study team in issue resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team
Under supervision author clinical sections of regulatory documents such as Investigator Brochure, Annual Reports, Investigational New Drug sections and clinical study reports.
May co‑author abstracts, posters, presentations and publications.
May contribute to budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators
May support Clinical Regulatory Authority interactions and provide responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials.
BASIC QUALIFICATIONS
Medical degree (M.D./D.O. or equivalent).
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post‑"intern/houseman" year) and have used the license to prescribe medicines in a patient‑care setting for a cumulative duration of at least one year.
0–4 years of work experience.
Ability to critically evaluate medical/scientific information.
Excellent written and oral communication.
Understanding of the design, development, and execution of clinical programs and studies.
Capacity to adapt to a fast pace and changing environment.
PREFERRED QUALIFICATIONS
Documented work experience/knowledge of statistics.
Training and experience in infectious diseases and/or infection control in the hospital setting.
Experience with investigational clinical trials.
No pharmaceutical industry experience required.
Demonstrated breadth of diverse leadership experiences and capabilities, including influence, collaboration with peers, coaching others, and guiding colleagues to achieve meaningful outcomes and create business impact.
WORK LOCATION This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week or more as needed.
SALARY & BENEFITS The annual base salary ranges from $189,200.00 to $303,300.00. The position is eligible for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and our share‑based long‑term incentive program. Pfizer offers comprehensive and generous benefits and programs to help colleagues lead healthy lives. Benefits include a 401(k) plan with Pfizer Matching Contributions, an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage).
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, 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.
ACCESSIBILITY Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
#J-18808-Ljbffr
United States - New York - Pearl River
United States - Pennsylvania - Collegeville
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.
ROLE SUMMARY The primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for the execution of the overall program. Importantly, this role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.
ROLE RESPONSIBILITIES Accountable for safety across the study
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP). Perform and document regular review of individual subject safety data and review cumulative safety data with the safety risk lead. Delegate these responsibilities to the study clinician scientist identified in the SSRP as appropriate. Detail the components of safety data review in the relevant SOPs and “Safety Data Review Guide – for Clinicians.”
Monitor study safety issues and provide input to serious adverse event (SAE) reports, providing appropriate medical context in terms of risk factors, medical history and other important medical factors.
Participate in the Safety Review Team to evaluate medical benefits/risks for targeted clinical indications.
Review literature as needed to respond to safety questions posed by the Safety Review Team, Data Monitoring Committee (DMC) or other stakeholders.
Communicate safety information to sites across the study and respond to safety questions.
Protocol design and strategy
Contribute medical input during protocol development and updates to the clinical development plan.
Work closely with other medical monitors to ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and have been reviewed by IRB/IECs.
Provide medical input into country feasibility.
Support study team
Provide clinical input to protocol and study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed.
Contribute to contract research organization/vendor selection to ensure the study is conducted consistently with protocol requirements, clinical plan expectations and study timelines, ensuring medical/technical data integrity requirements are applied.
Work with study team to ensure high quality of data, e.g., appropriate patient population, adequacy of clinical assessments during the study.
Contribute to medical review and interpretation of efficacy and safety data, delivering top‑line reports in collaboration with the statistician and clinical study reports with the medical writer, accountable for overall quality and timeliness of analysis and reporting.
Provide protocol‑specific training to study team, investigators, clinical research associates and others.
Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level.
Interact with DMCs and steering committees as required.
Notify study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
Monitor investigator compliance with protocol and regulatory requirements.
Support study team in issue resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team
Under supervision author clinical sections of regulatory documents such as Investigator Brochure, Annual Reports, Investigational New Drug sections and clinical study reports.
May co‑author abstracts, posters, presentations and publications.
May contribute to budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators
May support Clinical Regulatory Authority interactions and provide responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries to build a network for new trials.
BASIC QUALIFICATIONS
Medical degree (M.D./D.O. or equivalent).
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post‑"intern/houseman" year) and have used the license to prescribe medicines in a patient‑care setting for a cumulative duration of at least one year.
0–4 years of work experience.
Ability to critically evaluate medical/scientific information.
Excellent written and oral communication.
Understanding of the design, development, and execution of clinical programs and studies.
Capacity to adapt to a fast pace and changing environment.
PREFERRED QUALIFICATIONS
Documented work experience/knowledge of statistics.
Training and experience in infectious diseases and/or infection control in the hospital setting.
Experience with investigational clinical trials.
No pharmaceutical industry experience required.
Demonstrated breadth of diverse leadership experiences and capabilities, including influence, collaboration with peers, coaching others, and guiding colleagues to achieve meaningful outcomes and create business impact.
WORK LOCATION This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week or more as needed.
SALARY & BENEFITS The annual base salary ranges from $189,200.00 to $303,300.00. The position is eligible for participation in Pfizer’s Global Performance Plan (bonus target 22.5% of base salary) and our share‑based long‑term incentive program. Pfizer offers comprehensive and generous benefits and programs to help colleagues lead healthy lives. Benefits include a 401(k) plan with Pfizer Matching Contributions, an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage).
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, 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.
ACCESSIBILITY Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
#J-18808-Ljbffr