Pfizer
Director, Clinical Development - Immunology & Inflammation
Pfizer, Cambridge, Massachusetts, us, 02140
ROLE SUMMARY
The purpose of 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 coordinate phase 14 trial designs in collaboration with statistics and clinical pharmacology lines and support study implementation with Pfizer clinical development operations to meet enrollment and study delivery timelines. The clinical study lead will be the primary liaison for investigators with enrollment or extraordinary protocol issues and may conduct study site visits to ensure timely study delivery. Activities span from discovery research through study execution, approval/submission and post-approval and the individual 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 (Statistics, Clinical Pharmacology, Regulatory, Operations, commercial development, etc.). Develop primary and secondary endpoints for efficacy and safety and contribute to the precision medicine, biomarker strategy, biostatistics analytic plan, regulatory requirements, pricing, marketing and medical needs aligned with the transition target product profile. Develop a network of consultants and KOLs for programs in new indications. Join project teams from FIH through post-approval to ensure clinical development strategies are in place, implemented and contributing to key milestones such as start-up and delivery of clinical trials. Accountable for safety across the study, including regular review of safety data and response to safety issues. Provide leadership in preparing critical documents (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 trust between teams, sub-teams, and leaders. Coordinate with other clinical activities in Immunology & Inflammation and the broader PRD organization. Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas. Develop effective collaborations with project team members, including biostatistics, regulatory affairs, clinical pharmacology, medical affairs, commercial development and development operations. Collaborate with key PRD partners in the design of clinical studies and develop target clinical goals to benchmark success. Interpret final clinical data to achieve study objectives and develop the clinical strategy. Establish relationships with external experts, consultants, opinion leaders, regulators and disease-specific investigator networks. Opportunity to participate in strategic assessment of the Immunology & Inflammation portfolio and Business Development activities. Demonstrate breadth of diverse leadership experiences and the ability to influence, coach others, oversee and guide the work of colleagues to achieve meaningful outcomes and business impact. QUALIFICATIONS
MD or MD/PhD (or equivalent) with relevant postgraduate clinical training. 4+ years' relevant work experience preferred. Preference for established record in execution of clinical trials in the pharmaceutical industry; experience managing complex projects. Firm understanding of drug development with emphasis on early clinical development. Scientific excellence with deep knowledge of Immunology & Inflammation and Dermatology. Superior clinical ability with relevant disease area knowledge and experience. Ability to design, initiate and conduct effective clinical studies and integrate these plans into a cohesive development strategy. Strong understanding of complexities and developments in the relevant disease/technical area and ability to apply to drug development. Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. Experience with ownership of budgets and financial risk management. Ability to review and interpret emerging data and proactively ensure delivery of quality study results. Skilled communicator and team leader, able to articulate ideas and integrate feedback. Ability to navigate a complex matrixed environment and manage diverse teams across 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 annual base salary for this position ranges from $226,300 to $377,100. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25% of base salary and eligibility to participate in our long-term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, paid vacation, holidays, personal days, caregiver/parental and medical leave, and health benefits. Learn more at Pfizer Candidate Site. Salary ranges vary by location. Relocation assistance may be available based on business needs and eligibility. Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. Details about reporting may be provided to government agencies. For any questions regarding this matter, contact Talent Acquisition. EEO & Employment Eligibility
Pfizer is an equal opportunity employer. This position requires permanent work authorization in the United States. Pfizer complies with nondiscrimination and work authorization laws. This site is accessible; for accessibility assistance, contact disabilityrecruitment@. #J-18808-Ljbffr
The purpose of 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 coordinate phase 14 trial designs in collaboration with statistics and clinical pharmacology lines and support study implementation with Pfizer clinical development operations to meet enrollment and study delivery timelines. The clinical study lead will be the primary liaison for investigators with enrollment or extraordinary protocol issues and may conduct study site visits to ensure timely study delivery. Activities span from discovery research through study execution, approval/submission and post-approval and the individual 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 (Statistics, Clinical Pharmacology, Regulatory, Operations, commercial development, etc.). Develop primary and secondary endpoints for efficacy and safety and contribute to the precision medicine, biomarker strategy, biostatistics analytic plan, regulatory requirements, pricing, marketing and medical needs aligned with the transition target product profile. Develop a network of consultants and KOLs for programs in new indications. Join project teams from FIH through post-approval to ensure clinical development strategies are in place, implemented and contributing to key milestones such as start-up and delivery of clinical trials. Accountable for safety across the study, including regular review of safety data and response to safety issues. Provide leadership in preparing critical documents (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 trust between teams, sub-teams, and leaders. Coordinate with other clinical activities in Immunology & Inflammation and the broader PRD organization. Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas. Develop effective collaborations with project team members, including biostatistics, regulatory affairs, clinical pharmacology, medical affairs, commercial development and development operations. Collaborate with key PRD partners in the design of clinical studies and develop target clinical goals to benchmark success. Interpret final clinical data to achieve study objectives and develop the clinical strategy. Establish relationships with external experts, consultants, opinion leaders, regulators and disease-specific investigator networks. Opportunity to participate in strategic assessment of the Immunology & Inflammation portfolio and Business Development activities. Demonstrate breadth of diverse leadership experiences and the ability to influence, coach others, oversee and guide the work of colleagues to achieve meaningful outcomes and business impact. QUALIFICATIONS
MD or MD/PhD (or equivalent) with relevant postgraduate clinical training. 4+ years' relevant work experience preferred. Preference for established record in execution of clinical trials in the pharmaceutical industry; experience managing complex projects. Firm understanding of drug development with emphasis on early clinical development. Scientific excellence with deep knowledge of Immunology & Inflammation and Dermatology. Superior clinical ability with relevant disease area knowledge and experience. Ability to design, initiate and conduct effective clinical studies and integrate these plans into a cohesive development strategy. Strong understanding of complexities and developments in the relevant disease/technical area and ability to apply to drug development. Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines. Experience with ownership of budgets and financial risk management. Ability to review and interpret emerging data and proactively ensure delivery of quality study results. Skilled communicator and team leader, able to articulate ideas and integrate feedback. Ability to navigate a complex matrixed environment and manage diverse teams across 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 annual base salary for this position ranges from $226,300 to $377,100. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25% of base salary and eligibility to participate in our long-term incentive program. Benefits include a 401(k) plan with Pfizer matching contributions, paid vacation, holidays, personal days, caregiver/parental and medical leave, and health benefits. Learn more at Pfizer Candidate Site. Salary ranges vary by location. Relocation assistance may be available based on business needs and eligibility. Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. Details about reporting may be provided to government agencies. For any questions regarding this matter, contact Talent Acquisition. EEO & Employment Eligibility
Pfizer is an equal opportunity employer. This position requires permanent work authorization in the United States. Pfizer complies with nondiscrimination and work authorization laws. This site is accessible; for accessibility assistance, contact disabilityrecruitment@. #J-18808-Ljbffr