Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
6 months ago
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Role Responsibilities:
- Lead the creation of the clinical development plan from pre-clinical stages through to proof of concept.
- Guide clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies; conceive novel study designs optimized for operational effectiveness, timely and cost-effective delivery.
- Oversee the design and execution of clinical research studies (methodology, clinical pharmacology, biomarker, proof of mechanism, proof of concept, medical device, etc.).
- Accountable for development of clinical documents (e.g., protocol, clinical report, and clinical components of regulatory submissions); provide final sign-off on documents.
- Serve as a Medically Qualified Individual (MQI), reviewing clinical trial data for safety signal identification and tracking.
- Provide input to operational strategy and feasibility of clinical research studies with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key clinical experts/sites and advise on site selection.
- Use deep medical/scientific expertise to support target progression from chemical/biologic synthesis to testing in humans.
- Manage a dynamic research portfolio; may run multiple programs in parallel.
- Contribute to technical and protocol review committees across the portfolio.
- May hold functional roles (e.g., Translational Medicine Lead; Research Project Leader).
Qualifications:
- MD or MD/PhD (or equivalent) with relevant postgraduate clinical training.
- Completion of an accredited cardiology fellowship (strongly preferred).
- Minimum 5 years industry experience in drug development or relevant biomedical research.
- Proven track record of scientific scholarship and achievement.
- Preference for a record executing clinical trials in the pharmaceutical industry; strong understanding of early clinical development.
- Scientific excellence; deep knowledge of integrated metabolism biology and metabolic diseases (cardiovascular/cardiometabolic disorders, obesity, diabetes, cachexia).
- Ability to design, initiate, and conduct effective clinical studies using novel principles and integrate them into a cohesive clinical development strategy.
- Strong understanding of disease/technical area complexities and current developments.
- Firm understanding of clinical regulatory requirements; knowledge of GCP and ICH guidelines.
- Ability to review and apply emerging data to ensure delivery of quality study results.
- Skilled communicator and team leader; able to operate in a complex matrix and manage diverse teams.
Preferred Qualifications:
- Board eligibility/certification in Cardiovascular Disease or related sub-specialty.
- Active medical license.
- Experience matrix managing project teams and/or serving as an RPL (teams 3–20) and managing 1–3 colleagues.
Benefits:
- Annual base salary range: $274,500.00 to $457,500.00.
- Eligible for Pfizer Global Performance Plan bonus target of 25% of base salary; and share-based long-term incentive program.
- Comprehensive benefits including 401(k) with Pfizer matching, additional retirement savings contribution, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage.
- Relocation assistance may be available based on business needs and/or eligibility.
Application instructions:
- None stated in the provided text.
- Lead the creation of the clinical development plan from pre-clinical stages through to proof of concept.
- Guide clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies; conceive novel study designs optimized for operational effectiveness, timely and cost-effective delivery.
- Oversee the design and execution of clinical research studies (methodology, clinical pharmacology, biomarker, proof of mechanism, proof of concept, medical device, etc.).
- Accountable for development of clinical documents (e.g., protocol, clinical report, and clinical components of regulatory submissions); provide final sign-off on documents.
- Serve as a Medically Qualified Individual (MQI), reviewing clinical trial data for safety signal identification and tracking.
- Provide input to operational strategy and feasibility of clinical research studies with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key clinical experts/sites and advise on site selection.
- Use deep medical/scientific expertise to support target progression from chemical/biologic synthesis to testing in humans.
- Manage a dynamic research portfolio; may run multiple programs in parallel.
- Contribute to technical and protocol review committees across the portfolio.
- May hold functional roles (e.g., Translational Medicine Lead; Research Project Leader).
Qualifications:
- MD or MD/PhD (or equivalent) with relevant postgraduate clinical training.
- Completion of an accredited cardiology fellowship (strongly preferred).
- Minimum 5 years industry experience in drug development or relevant biomedical research.
- Proven track record of scientific scholarship and achievement.
- Preference for a record executing clinical trials in the pharmaceutical industry; strong understanding of early clinical development.
- Scientific excellence; deep knowledge of integrated metabolism biology and metabolic diseases (cardiovascular/cardiometabolic disorders, obesity, diabetes, cachexia).
- Ability to design, initiate, and conduct effective clinical studies using novel principles and integrate them into a cohesive clinical development strategy.
- Strong understanding of disease/technical area complexities and current developments.
- Firm understanding of clinical regulatory requirements; knowledge of GCP and ICH guidelines.
- Ability to review and apply emerging data to ensure delivery of quality study results.
- Skilled communicator and team leader; able to operate in a complex matrix and manage diverse teams.
Preferred Qualifications:
- Board eligibility/certification in Cardiovascular Disease or related sub-specialty.
- Active medical license.
- Experience matrix managing project teams and/or serving as an RPL (teams 3–20) and managing 1–3 colleagues.
Benefits:
- Annual base salary range: $274,500.00 to $457,500.00.
- Eligible for Pfizer Global Performance Plan bonus target of 25% of base salary; and share-based long-term incentive program.
- Comprehensive benefits including 401(k) with Pfizer matching, additional retirement savings contribution, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage.
- Relocation assistance may be available based on business needs and/or eligibility.
Application instructions:
- None stated in the provided text.