Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
6 months ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role Responsibilities:
- Leads creation of the clinical development plan from pre-clinical stages through proof of concept.
- Guides clinical team members to translate clinical research plans into efficiently delivered studies; conceives novel study designs and collaborates to optimize them for operational effectiveness.
- Oversees 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, clinical components of regulatory submissions); provides final sign-off for documents generated by Clinical Development Scientists.
- Serves as a Medically Qualified Individual (MQI), reviewing clinical trial data for safety signal identification and tracking.
- Provides input to operational strategy and feasibility of clinical research studies.
- Establishes relationships with key clinical experts/sites to advise the clinical team on site selection.
- Uses deep medical/scientific expertise to help select targets for progression from chemical/biologic synthesis to testing in humans.
- Manages a dynamic portfolio and may manage multiple programs in parallel.
- Contributes to technical and protocol review committees across the portfolio.
- May hold concomitant roles: Translational Medicine Lead (TML) and/or Research Project Leader (RPL).
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 established record executing clinical trials 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; integrate into a cohesive clinical development strategy.
- Strong understanding of disease/technical area developments.
- Firm understanding of clinical regulatory requirements; knowledge of GCP and ICH guidelines.
- Ability to review emerging data and proactively ensure quality study results.
- Skilled communicator and team leader; experience navigating matrix environments and managing geographically 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.
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.
- Benefits may include 401(k) with matching contributions, paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision).
- Relocation assistance may be available based on business needs/eligibility.
Application Instructions:
- Not provided in the job description text.
- Leads creation of the clinical development plan from pre-clinical stages through proof of concept.
- Guides clinical team members to translate clinical research plans into efficiently delivered studies; conceives novel study designs and collaborates to optimize them for operational effectiveness.
- Oversees 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, clinical components of regulatory submissions); provides final sign-off for documents generated by Clinical Development Scientists.
- Serves as a Medically Qualified Individual (MQI), reviewing clinical trial data for safety signal identification and tracking.
- Provides input to operational strategy and feasibility of clinical research studies.
- Establishes relationships with key clinical experts/sites to advise the clinical team on site selection.
- Uses deep medical/scientific expertise to help select targets for progression from chemical/biologic synthesis to testing in humans.
- Manages a dynamic portfolio and may manage multiple programs in parallel.
- Contributes to technical and protocol review committees across the portfolio.
- May hold concomitant roles: Translational Medicine Lead (TML) and/or Research Project Leader (RPL).
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 established record executing clinical trials 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; integrate into a cohesive clinical development strategy.
- Strong understanding of disease/technical area developments.
- Firm understanding of clinical regulatory requirements; knowledge of GCP and ICH guidelines.
- Ability to review emerging data and proactively ensure quality study results.
- Skilled communicator and team leader; experience navigating matrix environments and managing geographically 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.
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.
- Benefits may include 401(k) with matching contributions, paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health coverage (medical, prescription drug, dental, vision).
- Relocation assistance may be available based on business needs/eligibility.
Application Instructions:
- Not provided in the job description text.