Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
6 months ago
Remote friendly (Cambridge, MA)
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 translate clinical research plans into efficiently delivered studies; develop novel study designs and optimize them 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 studies, etc.).
- Accountable for development of clinical documents (e.g., protocol, clinical report, clinical components of regulatory submissions), including final sign-off on documents generated by Clinical development scientists.
- 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 knowledge to select targets for progression from chemical/biologic synthesis to human testing.
- Support a dynamic research portfolio; may manage multiple programs in parallel.
- Contribute to technical and protocol review committees across the portfolio.
- May hold additional 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 of industry experience in drug development or relevant biomedical research experience.
- Proven track record of scientific scholarship and achievement.
- Preference for established clinical trial execution experience in the pharmaceutical industry; strong understanding of early clinical development.
- Deep knowledge of integrated metabolism biology and metabolic diseases (cardiovascular/cardiometabolic disorders, obesity, diabetes, cachexia).
- Ability to design, initiate, and conduct effective clinical studies and integrate them into a cohesive clinical development strategy.
- Strong understanding of current developments in the relevant disease/technical area.
- Firm understanding of clinical regulatory requirements, GCP, and ICH guidelines.
- Ability to review emerging data and proactively ensure quality study results.
- Skilled communicator and team leader.
- Ability to navigate a complex matrixed environment and manage diverse teams.
Preferred Qualifications:
- Board eligibility/certification in Cardiovascular Disease or related subspecialty.
- Active medical license.
- Ability to serve as a matrix manager of project teams/global medicines clinical subteams; may serve as RPL and/or directly manage 1–3 colleagues.
Benefits:
- Annual base salary range: $274,500.00 to $457,500.00.
- Eligible for Pfizer Global Performance Plan bonus target of 25.0% of base salary and share-based long-term incentive program.
- Benefits include 401(k) with Pfizer matching contributions and additional retirement savings contribution, paid vacation/holiday/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
- Relocation assistance may be available based on business needs and/or eligibility.
Application instructions:
- Candidates must be authorized to be employed in the U.S.; U.S. work visa sponsorship is not available for this role now or in the future.
- Lead the creation of the clinical development plan from pre-clinical stages through to proof of concept.
- Guide clinical team members to translate clinical research plans into efficiently delivered studies; develop novel study designs and optimize them 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 studies, etc.).
- Accountable for development of clinical documents (e.g., protocol, clinical report, clinical components of regulatory submissions), including final sign-off on documents generated by Clinical development scientists.
- 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 knowledge to select targets for progression from chemical/biologic synthesis to human testing.
- Support a dynamic research portfolio; may manage multiple programs in parallel.
- Contribute to technical and protocol review committees across the portfolio.
- May hold additional 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 of industry experience in drug development or relevant biomedical research experience.
- Proven track record of scientific scholarship and achievement.
- Preference for established clinical trial execution experience in the pharmaceutical industry; strong understanding of early clinical development.
- Deep knowledge of integrated metabolism biology and metabolic diseases (cardiovascular/cardiometabolic disorders, obesity, diabetes, cachexia).
- Ability to design, initiate, and conduct effective clinical studies and integrate them into a cohesive clinical development strategy.
- Strong understanding of current developments in the relevant disease/technical area.
- Firm understanding of clinical regulatory requirements, GCP, and ICH guidelines.
- Ability to review emerging data and proactively ensure quality study results.
- Skilled communicator and team leader.
- Ability to navigate a complex matrixed environment and manage diverse teams.
Preferred Qualifications:
- Board eligibility/certification in Cardiovascular Disease or related subspecialty.
- Active medical license.
- Ability to serve as a matrix manager of project teams/global medicines clinical subteams; may serve as RPL and/or directly manage 1–3 colleagues.
Benefits:
- Annual base salary range: $274,500.00 to $457,500.00.
- Eligible for Pfizer Global Performance Plan bonus target of 25.0% of base salary and share-based long-term incentive program.
- Benefits include 401(k) with Pfizer matching contributions and additional retirement savings contribution, paid vacation/holiday/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
- Relocation assistance may be available based on business needs and/or eligibility.
Application instructions:
- Candidates must be authorized to be employed in the U.S.; U.S. work visa sponsorship is not available for this role now or in the future.