Pfizer
Director, Clinical Development - Immunology & Inflammation
Pfizer, Cambridge, Massachusetts, us, 02140
Director Of Clinical Research
The purpose of the Director Of Clinical Research role is to coordinate and lead the development of end to end clinical development plans, first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA), proof of concept (PoC), dose ranging, pivotal and post approval studies for novel biological and small molecule therapies in Immunology and Inflammation programs. The Director Of Clinical Research will be responsible for phase 1, 2, PoM and SoCA, phase 3 and 4 trial designs that will be developed in collaboration with statistics and clinical pharmacology lines. They also will be involved in the implementation of the study in collaboration with Pfizer clinical development operations and the project team to meet enrollment and study delivery timelines. The clinical study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need to conduct study site visits to ensure timely delivery of the study. The individual will be involved in activities from discovery research through study execution, approval/submission and post approval. They will be a key member on project teams. Role Responsibilities
The Director Of Clinical Research will be responsible for the following: Design clinical studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, commercial development etc.). Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine, biomarker strategy as well as to the biostatistics analytic plan, regulatory requirements, pricing, marketing and medical needs that is aligned with the transition target product profile. Develop a network or consultants and KoLs for programs in new indications Sit on project teams from FIH through post approval to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g., start-up and delivery of clinical trials. Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues. Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. Expand the culture of collaboration by maintaining open communications and ensuring successful program transitions. Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders. Coordinate with other clinical activities in I&I and the greater PRD organization. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues. Develop effective collaborations with projects team members, including biostatistics, regulatory affairs, clinical pharmacology, medical affairs, commercial development and development operations. Develop effective collaborations with key PRD partners in design of clinical studies and develop target clinical goals to benchmark success of these studies. Interpret final clinical data in achieving study objectives and develop the clinical strategy. Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks. The applicant will have the opportunity to participate in strategic assessment of I&I portfolio, and Business Development activities. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Qualifications
MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training. 4+ years' relevant work experience preferred. Preference for established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Firm understanding of the drug development process with particular emphasis on early clinical development. Scientific excellence; possesses deep knowledge of I&I and Dermatology. Superior clinical ability with relevant disease area knowledge and experience. Ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy. Strong understanding of the complexities and current developments in the relevant disease/technical area and skillfully applies this knowledge to drug development. Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. Experienced with ownership of budgets and sound financial risk management. Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results. Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback. Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography. Preferred Qualifications
Board eligibility/certification in Dermatology. Active medical license preferred. Non-Standard Work Schedule, Travel or Environment Requirements
Work Location Assignment: On premise Relocation Support Available: Yes
The purpose of the Director Of Clinical Research role is to coordinate and lead the development of end to end clinical development plans, first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA), proof of concept (PoC), dose ranging, pivotal and post approval studies for novel biological and small molecule therapies in Immunology and Inflammation programs. The Director Of Clinical Research will be responsible for phase 1, 2, PoM and SoCA, phase 3 and 4 trial designs that will be developed in collaboration with statistics and clinical pharmacology lines. They also will be involved in the implementation of the study in collaboration with Pfizer clinical development operations and the project team to meet enrollment and study delivery timelines. The clinical study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need to conduct study site visits to ensure timely delivery of the study. The individual will be involved in activities from discovery research through study execution, approval/submission and post approval. They will be a key member on project teams. Role Responsibilities
The Director Of Clinical Research will be responsible for the following: Design clinical studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, commercial development etc.). Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine, biomarker strategy as well as to the biostatistics analytic plan, regulatory requirements, pricing, marketing and medical needs that is aligned with the transition target product profile. Develop a network or consultants and KoLs for programs in new indications Sit on project teams from FIH through post approval to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g., start-up and delivery of clinical trials. Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues. Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. Expand the culture of collaboration by maintaining open communications and ensuring successful program transitions. Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders. Coordinate with other clinical activities in I&I and the greater PRD organization. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues. Develop effective collaborations with projects team members, including biostatistics, regulatory affairs, clinical pharmacology, medical affairs, commercial development and development operations. Develop effective collaborations with key PRD partners in design of clinical studies and develop target clinical goals to benchmark success of these studies. Interpret final clinical data in achieving study objectives and develop the clinical strategy. Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks. The applicant will have the opportunity to participate in strategic assessment of I&I portfolio, and Business Development activities. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Qualifications
MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training. 4+ years' relevant work experience preferred. Preference for established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Firm understanding of the drug development process with particular emphasis on early clinical development. Scientific excellence; possesses deep knowledge of I&I and Dermatology. Superior clinical ability with relevant disease area knowledge and experience. Ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy. Strong understanding of the complexities and current developments in the relevant disease/technical area and skillfully applies this knowledge to drug development. Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. Experienced with ownership of budgets and sound financial risk management. Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results. Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback. Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography. Preferred Qualifications
Board eligibility/certification in Dermatology. Active medical license preferred. Non-Standard Work Schedule, Travel or Environment Requirements
Work Location Assignment: On premise Relocation Support Available: Yes