Clinical Development Medical Senior Director
Pfizer, S.A. de C.V, Cambridge, Massachusetts, us, 02140
Clinical Development Medical Senior Director
United States - Massachusetts - Cambridge
United States - Connecticut - Groton
United States - Pennsylvania - Collegeville
United States - New York - New York City
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.
Job Responsibilities Leadership
Autonomously and independently leads clinical execution of one or more studies of high complexity and significant business impact. May be accountable for program level clinical deliverables.
Leads innovative approaches to clinical development, develops options and oversees implementation of solutions for complex problems.
May lead or chair cross‑functional teams at the category or portfolio level including governance or advisory committees.
Provides matrix management to clinical colleagues or a cross‑functional team in clinical development.
Content Creation
Provides clinical/medical input to support development of the protocol design document (PDD).
Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant/site engagement while minimizing the likelihood of amendments or quality issues. Partners with/ supports the Global Development Lead in governance review and approval process.
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
Clinical & Safety Oversight
Performs medical monitoring on one or more clinical trials.
Provides study‑related medical information and assistance, e.g., medical questions from investigators, site personnel and non‑study health care providers, safety findings, medical issues and complex serious adverse events, audits or inspection medical responses.
Provides clinical/medical input to the development of data collection tools.
Responsible for providing clinical/medical input to SAP, TLFs and BDR.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Reviews and approves final document.
Inputs to, reviews, and approves, Risk Management and Safety Review Plan; ensures activities are conducted consistent with the approved plan and partners with key stakeholders to develop and implement any risk mitigations.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol.
Contributes to final significant quality event medical assessments.
Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
Reviews required safety text and endorses significant medical changes in the ICD.
Reviews, reports and manages protocol deviations.
Reviews patient level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g., ICD) are updated as required.
Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
Ensures TMF compliance for clinical documents.
Clinical Reporting
May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and regulatory authority responses) if required.
May support responsible colleagues with the development of responses to regulatory queries and Clinical Trial Applications (CTAs).
Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.
Basic Qualifications
Obtained a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university and has 7+ years of experience in the biopharmaceutical industry in clinical research and development.
Been licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years post intern/house officer/foundation period.
Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority.
Clinical research experience in phase 3/pivotal space.
Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
Demonstrated experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology).
Broad leadership experience and capabilities, including influence, collaboration, coaching, oversight, and business impact creation.
Passion for helping patients.
Proven analytical skills with ability to work on large data sets.
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English.
Global perspective and mindset, working well in a diverse team environment.
Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre‑clinical, pharmacology, quality assurance).
Proficient with basic IT; efficiently using a computer and telecommunications (voice and video).
Flexibility to adapt and navigate through an ever‑changing work environment while maintaining integrity and quality.
Relevant personality features and competencies: problem‑solving, agile decision‑making, knowledge sharing, embracing evolving technologies, promoting team health, foresight in complex decisions, communication tool use, partnership building, conflict resolution, innovation, and proactive organization of tasks and priorities.
Non‑Standard Work Schedule, Travel or Environment Requirements Global travel might be required.
Relocation support available.
Salary and Compensation The annual base salary for this position ranges from $254,100.00 to $403,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage). Compensation and benefits are aligned based on location of hire; the United States salary range does not apply to Tampa, FL or any location outside the United States.
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. If you are a licensed physician who incurs recruiting expenses that we pay or reimburse, your name, address and the amount of payments will be reported to the government. If you have questions regarding this matter, please 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 complies with all applicable national, state and local laws governing nondiscrimination in employment 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 for accommodation requests. Requests for any other reason will not be returned.
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United States - Massachusetts - Cambridge
United States - Connecticut - Groton
United States - Pennsylvania - Collegeville
United States - New York - New York City
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.
Job Responsibilities Leadership
Autonomously and independently leads clinical execution of one or more studies of high complexity and significant business impact. May be accountable for program level clinical deliverables.
Leads innovative approaches to clinical development, develops options and oversees implementation of solutions for complex problems.
May lead or chair cross‑functional teams at the category or portfolio level including governance or advisory committees.
Provides matrix management to clinical colleagues or a cross‑functional team in clinical development.
Content Creation
Provides clinical/medical input to support development of the protocol design document (PDD).
Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant/site engagement while minimizing the likelihood of amendments or quality issues. Partners with/ supports the Global Development Lead in governance review and approval process.
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
Clinical & Safety Oversight
Performs medical monitoring on one or more clinical trials.
Provides study‑related medical information and assistance, e.g., medical questions from investigators, site personnel and non‑study health care providers, safety findings, medical issues and complex serious adverse events, audits or inspection medical responses.
Provides clinical/medical input to the development of data collection tools.
Responsible for providing clinical/medical input to SAP, TLFs and BDR.
Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Reviews and approves final document.
Inputs to, reviews, and approves, Risk Management and Safety Review Plan; ensures activities are conducted consistent with the approved plan and partners with key stakeholders to develop and implement any risk mitigations.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol.
Contributes to final significant quality event medical assessments.
Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
Reviews required safety text and endorses significant medical changes in the ICD.
Reviews, reports and manages protocol deviations.
Reviews patient level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g., ICD) are updated as required.
Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
Ensures TMF compliance for clinical documents.
Clinical Reporting
May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and regulatory authority responses) if required.
May support responsible colleagues with the development of responses to regulatory queries and Clinical Trial Applications (CTAs).
Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.
Basic Qualifications
Obtained a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university and has 7+ years of experience in the biopharmaceutical industry in clinical research and development.
Been licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years post intern/house officer/foundation period.
Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority.
Clinical research experience in phase 3/pivotal space.
Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
Demonstrated experience establishing, managing, and training teams in clinical development.
Preferred Qualifications
Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology).
Broad leadership experience and capabilities, including influence, collaboration, coaching, oversight, and business impact creation.
Passion for helping patients.
Proven analytical skills with ability to work on large data sets.
Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English.
Global perspective and mindset, working well in a diverse team environment.
Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre‑clinical, pharmacology, quality assurance).
Proficient with basic IT; efficiently using a computer and telecommunications (voice and video).
Flexibility to adapt and navigate through an ever‑changing work environment while maintaining integrity and quality.
Relevant personality features and competencies: problem‑solving, agile decision‑making, knowledge sharing, embracing evolving technologies, promoting team health, foresight in complex decisions, communication tool use, partnership building, conflict resolution, innovation, and proactive organization of tasks and priorities.
Non‑Standard Work Schedule, Travel or Environment Requirements Global travel might be required.
Relocation support available.
Salary and Compensation The annual base salary for this position ranges from $254,100.00 to $403,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share‑based long‑term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental and vision coverage). Compensation and benefits are aligned based on location of hire; the United States salary range does not apply to Tampa, FL or any location outside the United States.
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. If you are a licensed physician who incurs recruiting expenses that we pay or reimburse, your name, address and the amount of payments will be reported to the government. If you have questions regarding this matter, please 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 complies with all applicable national, state and local laws governing nondiscrimination in employment 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 for accommodation requests. Requests for any other reason will not be returned.
#J-18808-Ljbffr