Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
19 days ago
Remote friendly (New York, NY)
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 team members to translate clinical research plans into efficiently delivered studies; conceive novel study designs optimized for operational effectiveness, timeliness, and cost.
- Oversee design and execution of clinical research studies (methodology, clinical pharmacology, biomarker, proof of mechanism, proof of concept, medical device).
- Accountable for clinical documents (protocols, clinical reports, and clinical components of regulatory submissions); provide final sign-off.
- Serve as a Medically Qualified Individual (MQI) reviewing clinical trial data for safety signal identification and tracking.
- Provide input on operational strategy and feasibility with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key clinical experts/sites to advise site selection.
- Apply medical/scientific expertise to select targets progressing from synthesis to human testing.
- Contribute to technical and protocol review committees.
- May hold concomitant roles: Translational Medicine Lead (surrogate markers/PD measurements; preclinical-to-human decision criteria) and/or Research Project Leader (target/compound to POC strategy; project team leadership).
Qualifications (Required):
- MD or MD/PhD with relevant postgraduate clinical training.
- Minimum 5 years industry experience in drug development or relevant biomedical research.
- Proven scientific scholarship/achievement.
- Strong understanding of early clinical development and drug development process.
- Deep knowledge of integrated metabolism biology and cardiometabolic/metabolic diseases.
- Ability to design/initiate/conduct clinical studies and integrate into a cohesive development strategy.
- Knowledge of clinical regulatory requirements, GCP, and ICH guidelines.
- Ability to review emerging data and ensure quality study results.
- Skilled communicator and team leader; manage diverse matrixed teams.
Preferred:
- Accredited cardiology fellowship completion.
- Board eligibility/certification in Cardiovascular Disease or related subspecialty.
- Active medical license.
Work/Environment:
- Up to 30% travel; hybrid—live within commuting distance and work on-site ~2.5 days/week or more as needed.
- Lead creation of the clinical development plan from pre-clinical stages through proof of concept.
- Guide clinical team members to translate clinical research plans into efficiently delivered studies; conceive novel study designs optimized for operational effectiveness, timeliness, and cost.
- Oversee design and execution of clinical research studies (methodology, clinical pharmacology, biomarker, proof of mechanism, proof of concept, medical device).
- Accountable for clinical documents (protocols, clinical reports, and clinical components of regulatory submissions); provide final sign-off.
- Serve as a Medically Qualified Individual (MQI) reviewing clinical trial data for safety signal identification and tracking.
- Provide input on operational strategy and feasibility with Clinical Development Scientists and Clinical Operations.
- Establish relationships with key clinical experts/sites to advise site selection.
- Apply medical/scientific expertise to select targets progressing from synthesis to human testing.
- Contribute to technical and protocol review committees.
- May hold concomitant roles: Translational Medicine Lead (surrogate markers/PD measurements; preclinical-to-human decision criteria) and/or Research Project Leader (target/compound to POC strategy; project team leadership).
Qualifications (Required):
- MD or MD/PhD with relevant postgraduate clinical training.
- Minimum 5 years industry experience in drug development or relevant biomedical research.
- Proven scientific scholarship/achievement.
- Strong understanding of early clinical development and drug development process.
- Deep knowledge of integrated metabolism biology and cardiometabolic/metabolic diseases.
- Ability to design/initiate/conduct clinical studies and integrate into a cohesive development strategy.
- Knowledge of clinical regulatory requirements, GCP, and ICH guidelines.
- Ability to review emerging data and ensure quality study results.
- Skilled communicator and team leader; manage diverse matrixed teams.
Preferred:
- Accredited cardiology fellowship completion.
- Board eligibility/certification in Cardiovascular Disease or related subspecialty.
- Active medical license.
Work/Environment:
- Up to 30% travel; hybrid—live within commuting distance and work on-site ~2.5 days/week or more as needed.