Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
19 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Role Responsibilities:
- Lead creation of the clinical development plan from pre-clinical stages through proof of concept.
- Guide clinical teams to translate research plans into efficiently delivered studies; conceive novel, operationally effective study designs.
- Oversee design and execution of clinical research studies (methodology, clinical pharmacology, biomarkers, proof of mechanism, proof of concept, medical device, etc.).
- Accountable for clinical documents (protocols, clinical reports, and clinical components of regulatory submissions); provides final sign-off.
- Serve as a Medically Qualified Individual (MQI) reviewing trial data for safety signal identification and tracking.
- Provide input to operational strategy and feasibility with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key experts/sites to advise on site selection.
- Contribute to target progression selection from chemical/biologic synthesis to human testing.
- Manage dynamic portfolios; may manage multiple programs in parallel.
- Contribute to technical and protocol review committees.
- Possible concomitant roles: Translational Medicine Lead (TML) and/or Research Project Leader (RPL) as needed.
Qualifications:
- MD or MD/PhD with relevant postgraduate clinical training.
- Accredited cardiology fellowship strongly preferred.
- Minimum 5 years industry drug development or relevant biomedical research experience.
- Proven scientific scholarship.
- Demonstrated execution record in pharmaceutical early clinical development.
- Deep knowledge of integrated metabolism biology/cardiometabolic diseases (e.g., obesity, diabetes, cardiovascular/cardiometabolic disorders, cachexia).
- Ability to design/initiate/conduct novel clinical studies and integrate into a cohesive development strategy.
- Strong disease/technical area understanding.
- Understanding of clinical regulatory requirements; knowledge of GCP and ICH.
- Ability to review emerging data and ensure quality study results.
- Skilled communicator and team leader; manage matrixed, diverse teams geographically.
Preferred Qualifications/Skills:
- Board eligibility/certification in Cardiovascular Disease or related specialty; active medical license preferred.
- Experience matrix managing clinical subteams and/or teams (as RPL) sized ~3–20.
Benefits (if offered in the posting):
- Bonus target 25% of base salary; participation in Pfizer share-based long-term incentive program; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Travel/Work Schedule:
- Up to 30% travel; hybrid role working on-site ~2.5 days/week.
- Relocation support available (if applicable).
Application instructions:
- Not specified in the provided text.
- Lead creation of the clinical development plan from pre-clinical stages through proof of concept.
- Guide clinical teams to translate research plans into efficiently delivered studies; conceive novel, operationally effective study designs.
- Oversee design and execution of clinical research studies (methodology, clinical pharmacology, biomarkers, proof of mechanism, proof of concept, medical device, etc.).
- Accountable for clinical documents (protocols, clinical reports, and clinical components of regulatory submissions); provides final sign-off.
- Serve as a Medically Qualified Individual (MQI) reviewing trial data for safety signal identification and tracking.
- Provide input to operational strategy and feasibility with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key experts/sites to advise on site selection.
- Contribute to target progression selection from chemical/biologic synthesis to human testing.
- Manage dynamic portfolios; may manage multiple programs in parallel.
- Contribute to technical and protocol review committees.
- Possible concomitant roles: Translational Medicine Lead (TML) and/or Research Project Leader (RPL) as needed.
Qualifications:
- MD or MD/PhD with relevant postgraduate clinical training.
- Accredited cardiology fellowship strongly preferred.
- Minimum 5 years industry drug development or relevant biomedical research experience.
- Proven scientific scholarship.
- Demonstrated execution record in pharmaceutical early clinical development.
- Deep knowledge of integrated metabolism biology/cardiometabolic diseases (e.g., obesity, diabetes, cardiovascular/cardiometabolic disorders, cachexia).
- Ability to design/initiate/conduct novel clinical studies and integrate into a cohesive development strategy.
- Strong disease/technical area understanding.
- Understanding of clinical regulatory requirements; knowledge of GCP and ICH.
- Ability to review emerging data and ensure quality study results.
- Skilled communicator and team leader; manage matrixed, diverse teams geographically.
Preferred Qualifications/Skills:
- Board eligibility/certification in Cardiovascular Disease or related specialty; active medical license preferred.
- Experience matrix managing clinical subteams and/or teams (as RPL) sized ~3–20.
Benefits (if offered in the posting):
- Bonus target 25% of base salary; participation in Pfizer share-based long-term incentive program; 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Travel/Work Schedule:
- Up to 30% travel; hybrid role working on-site ~2.5 days/week.
- Relocation support available (if applicable).
Application instructions:
- Not specified in the provided text.