Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer, S.A. de C.V, Lake Forest, IL, United States
Global Development Lead, Internal Medicine (MD, Sr. Director)
United States - Washington – Bothell
United States - New York - Pearl River
United States - New York - New York City
United States - Pennsylvania - Collegeville
United States - Massachusetts - Cambridge
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 Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. The individual will lead the cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—in the design, execution and interpretation of studies in support of worldwide regulatory submissions.
The individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents. The GDL is a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s), and may also partner with external companies in support of Pfizer’s Partner of Choice model. The individual is expected to be an internal subject‑matter expert in their therapeutic area and in clinical drug development.
Responsibilities
Partner effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
Lead the cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—in the design, execution and interpretation of studies supporting worldwide regulatory submissions.
Be accountable for creating and obtaining endorsement for the Clinical Development Plan and associated protocol design documents.
Serve as a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s).
Provide specialized monitoring support when required.
Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview.
Provide input for target product profile(s) and support regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit‑Risk Evaluation Reports.
Develop comprehensive clinical development plans to secure approval and reimbursement globally (including China and Japan) and create pediatric investigation plans and study plans.
Provide product/program specific input for target product profiles.
Bring innovative thinking and bold decision‑making across clinical development programs and individual studies.
Develop and implement specific clinical development enabling strategies, including digital/innovation and patient engagement approaches.
Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide clinical development strategy input and insights.
Provide therapy‑area/indication expertise in support of clinical data review—including CRF design, signal interpretation, and contextualizing adverse events.
Act as a key partner in trial‑level statistical analysis plan, table‑listings‑figures, and database release in partnership with statistics and programming.
Develop submission‑level deliverables (IAP, IARP and submission TLFs) and be responsible for submission deliverables including SCE and SCS.
Support appropriate interpretation and communication of clinical trial data.
Review and approve submission‑level safety narrative plans.
Support product label development and maintenance.
Engage key external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients and patient advocates) to drive strategic insight generation supporting clinical development strategy and PDD development.
Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense.
Ensure compliance with internal SOPs and external regulatory standards.
Review IIR proposals.
BASIC QUALIFICATIONS Education
MD or DO
Experience
Cardiologist with cardiovascular outcome trials or large complex, global development programs.
8+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
Demonstrated clinical/medical, administrative, and project‑management capabilities, and effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.
Demonstrated experience managing and training large teams in clinical development.
Demonstrated experience in designing and launching large teams (preferred).
Competency Requirements
Medical / scientific credibility and excellence—track record of achievement in pharmaceutical development, ability to coordinate and execute clinical development or lifecycle strategy, and understanding of complexities and recent developments in the principal disease areas.
Management experience—able to work in a highly complex matrixed environment and influence cross‑functional teams.
Leadership—persuasive and effective leader of staff.
Influencing—able to manage and motivate internal teams on clinical trials.
Conflict management—mentor/coach others to improve conflict‑management skills, step up to conflicts and settle disputes equitably.
Team building—create strong morale and spirit, share wins, foster open dialogue, and give team members responsibility for their work.
Accountability—take personal responsibility for results and push self and others to exceed goals.
Change agility—demonstrate perspective and poise in the face of uncertainty and get things done amid organizational change.
Broad leadership experience and capabilities—including influencing, collaborating with peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes and business impact.
Non‑Standard Work Schedule, Travel or Environment Requirements Up to 30% travel may be required.
Relocation support available.
Work location assignment: this is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week.
Compensation The annual base salary for this position ranges from $274,500.00 to $444,100.00. 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. 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, 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. The annual base salary for this position in Tampa, FL ranges from $217,800.00 to $363,000.00.
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.
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.
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United States - Washington – Bothell
United States - New York - Pearl River
United States - New York - New York City
United States - Pennsylvania - Collegeville
United States - Massachusetts - Cambridge
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 Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. The individual will lead the cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—in the design, execution and interpretation of studies in support of worldwide regulatory submissions.
The individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents. The GDL is a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s), and may also partner with external companies in support of Pfizer’s Partner of Choice model. The individual is expected to be an internal subject‑matter expert in their therapeutic area and in clinical drug development.
Responsibilities
Partner effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
Lead the cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—in the design, execution and interpretation of studies supporting worldwide regulatory submissions.
Be accountable for creating and obtaining endorsement for the Clinical Development Plan and associated protocol design documents.
Serve as a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s).
Provide specialized monitoring support when required.
Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview.
Provide input for target product profile(s) and support regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit‑Risk Evaluation Reports.
Develop comprehensive clinical development plans to secure approval and reimbursement globally (including China and Japan) and create pediatric investigation plans and study plans.
Provide product/program specific input for target product profiles.
Bring innovative thinking and bold decision‑making across clinical development programs and individual studies.
Develop and implement specific clinical development enabling strategies, including digital/innovation and patient engagement approaches.
Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide clinical development strategy input and insights.
Provide therapy‑area/indication expertise in support of clinical data review—including CRF design, signal interpretation, and contextualizing adverse events.
Act as a key partner in trial‑level statistical analysis plan, table‑listings‑figures, and database release in partnership with statistics and programming.
Develop submission‑level deliverables (IAP, IARP and submission TLFs) and be responsible for submission deliverables including SCE and SCS.
Support appropriate interpretation and communication of clinical trial data.
Review and approve submission‑level safety narrative plans.
Support product label development and maintenance.
Engage key external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients and patient advocates) to drive strategic insight generation supporting clinical development strategy and PDD development.
Provide regulatory submission support (DSUR, PBRER), disclosure deliverables, and product defense.
Ensure compliance with internal SOPs and external regulatory standards.
Review IIR proposals.
BASIC QUALIFICATIONS Education
MD or DO
Experience
Cardiologist with cardiovascular outcome trials or large complex, global development programs.
8+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
Demonstrated clinical/medical, administrative, and project‑management capabilities, and effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.
Demonstrated experience managing and training large teams in clinical development.
Demonstrated experience in designing and launching large teams (preferred).
Competency Requirements
Medical / scientific credibility and excellence—track record of achievement in pharmaceutical development, ability to coordinate and execute clinical development or lifecycle strategy, and understanding of complexities and recent developments in the principal disease areas.
Management experience—able to work in a highly complex matrixed environment and influence cross‑functional teams.
Leadership—persuasive and effective leader of staff.
Influencing—able to manage and motivate internal teams on clinical trials.
Conflict management—mentor/coach others to improve conflict‑management skills, step up to conflicts and settle disputes equitably.
Team building—create strong morale and spirit, share wins, foster open dialogue, and give team members responsibility for their work.
Accountability—take personal responsibility for results and push self and others to exceed goals.
Change agility—demonstrate perspective and poise in the face of uncertainty and get things done amid organizational change.
Broad leadership experience and capabilities—including influencing, collaborating with peers, developing and coaching others, and guiding colleagues to achieve meaningful outcomes and business impact.
Non‑Standard Work Schedule, Travel or Environment Requirements Up to 30% travel may be required.
Relocation support available.
Work location assignment: this is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week.
Compensation The annual base salary for this position ranges from $274,500.00 to $444,100.00. 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. 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, 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. The annual base salary for this position in Tampa, FL ranges from $217,800.00 to $363,000.00.
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.
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.
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