Global Development Lead, Early Clinical Development, Internal Medicine
Pfizer
6 months ago
Remote friendly (New York, 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; develop novel study designs optimized for operational effectiveness, timeliness, and cost-effectiveness.
- 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 for 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 expertise to contribute to target selection from chemical/biologic synthesis to testing in humans.
- Manage a dynamic portfolio and multiple programs in parallel as needed.
- Contribute to technical and protocol review committees.
Concomitant Functional Roles (may include)
- Translational Medicine Lead (TML): identify/validate surrogate disease markers and pharmacodynamic measurements; translate preclinical knowledge to human decision criteria.
- Research Project Leader (RPL): establish and execute research strategy from target/compound selection to proof of concept (POC), including operational expertise and cross-discipline interfaces.
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.
- Proven track record of scientific scholarship and achievement.
- Preference for established experience executing clinical trials in the pharmaceutical industry; strong understanding of drug development, with emphasis on 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 and integrate them into an overall 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 emerging data and proactively implement measures to ensure quality study results.
- Skilled communicator and team leader.
- Ability to navigate a complex matrix environment and manage geographically/diversely skilled teams.
Preferred Qualifications
- Board eligibility/certification in Cardiovascular Disease or related sub-specialty.
- Active medical license.
- Experience matrix managing project teams/clinical subteams; may also serve as RPL with matrix management of teams (size varies 3–20) depending on stage/complexity.
- May directly manage 1–3 colleagues depending on business needs and staffing.
- 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; develop novel study designs optimized for operational effectiveness, timeliness, and cost-effectiveness.
- 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 for 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 expertise to contribute to target selection from chemical/biologic synthesis to testing in humans.
- Manage a dynamic portfolio and multiple programs in parallel as needed.
- Contribute to technical and protocol review committees.
Concomitant Functional Roles (may include)
- Translational Medicine Lead (TML): identify/validate surrogate disease markers and pharmacodynamic measurements; translate preclinical knowledge to human decision criteria.
- Research Project Leader (RPL): establish and execute research strategy from target/compound selection to proof of concept (POC), including operational expertise and cross-discipline interfaces.
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.
- Proven track record of scientific scholarship and achievement.
- Preference for established experience executing clinical trials in the pharmaceutical industry; strong understanding of drug development, with emphasis on 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 and integrate them into an overall 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 emerging data and proactively implement measures to ensure quality study results.
- Skilled communicator and team leader.
- Ability to navigate a complex matrix environment and manage geographically/diversely skilled teams.
Preferred Qualifications
- Board eligibility/certification in Cardiovascular Disease or related sub-specialty.
- Active medical license.
- Experience matrix managing project teams/clinical subteams; may also serve as RPL with matrix management of teams (size varies 3–20) depending on stage/complexity.
- May directly manage 1–3 colleagues depending on business needs and staffing.