The overall role of the Early Clinical Development (ECD) Clinician is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for first in man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies in a given therapeutic areas: e.g. Immunology and Inflammation, Cardiovascular/Metabolic, Neruosciences, or Rare Disease.
The individual will be involved with clinical drug development activities from FIH through POC. They will be a key member and/or contact for project teams to ensure collaboration and seamless connectivity between ECD, Research Units and Global Product Development (late stage development and study operations).
Responsibilities
• Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
• Supports execution for all post-FIH programs through proof of mechanism and proof-of concept
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
• Support and assist in the development of publications, abstracts, and presentations
• Sit on project teams from FIH/POM/ESoE through POC trial completion to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials.
• Support preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
• Collaborate between the clinical team and ECD by maintaining open communications between the two groups and ensuring successful program completion.
• Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and therapeutic areas.
• Coordinate with other clinical research activities in ECD and greater World-Wide Research and Development (WRD) organization.
• Develop effective collaborations with key partners in Pfizer Discovery Research Units (RU) as well as Centers for Therapeutic Innovation (CTI) and Precision Medicine.
• Develop effective collaborations with project leaders and projects team members, including research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, precision medicine and development operations.
• Partner with Precision Medicine as needed to ensure that biomarker plans are enabled in all relevant therapeutic area programs to help determine early signs of efficacy and proof of concept, patient stratification, etc.
• Establish and support relationships with external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and guidelines into clinical development plans and study designs, as well as management and recruitment of study, analysis, interpretation and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
Qualifications
• Requires PhD, PharmD, MSc (relevant experience in Immunology and Inflammation, Cardiovascular/Metabolic, Neruosciences, or Rare Disease preferred)
• Deep understanding of the biopharmaceutical environment and the drug development
• 5-8 years of relevant experience in drug development; 3-5 years of relevant experience in a clinician type role with a proven track record executing development programs to completion or targeted milestone
• Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change across all levels of the organization including senior management
Technical Skills
• A clear working knowledge of the clinical development process
• Demonstrated ability to support the formulation and execution of clinical strategies; Experience in generating hypothesis driven research investigations
• Biopharmaceutical experience as a medical monitor and clinical lead for translational medicine projects across therapeutic areas is desirable.
• Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker based approaches.
• Ability to analyze and interpret complex datasets.
• Ability to operate with a sense of pace and urgency in matrixed project teams.
• Exercises initiative in meeting goals and drives innovation in projects.
• Demonstrated scientific productivity (publications, abstracts, etc.).
• Good communication and presentation skills as well as proven scientific writing skills.
Core Competencies
• Results-oriented with demonstrated track record of success in clinical development
• Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography
• Entrepreneurial mindset with the ability to bring creative solutions to challenges
• Ability to think and frame problems strategically
• Quick action taker, able to involve the right team members in the right situation at the right time with a fit for purpose attitude
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