Senior Director, Clinical Research- Specialty in Pulmonary Diseases – MD Required at Pfizer
Cambridge, MA 02138
About the Job
ROLE SUMMARYThe purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA) and proof of concept (PoC) and dose ranging studies for novel biological and small molecule therapies in programs focused on respiratory disease.The Senior Director of Clinical Research will be responsible for phase 2, PoM and SoCA trial designs and implementation of the study in collaboration with Pfizer 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 with a focus on clinical drug activities from discovery research through PoM, SoCA and PoC studies. They will be a key member on project teams to collaborate with Early Clinical Development (ECD) and ensure seamless transition of the new asset to the Pfizer Global Product Development (GPD) for Ph3 development. ROLE RESPONSIBILITIESThe Senior Director of Clinical Research will develop a disease specific global network of potential investigators and key opinion leaders (KOL) for the new therapeutic before PoM, SoCA or POC trial conception to assist in trial design, as well as management and recruitment of study, analysis, interpretation and presentation of results. Design PoM, SoCA or POC studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, etc.).
• Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile.
• Sit on project teams from FIH/POM/SOCA through POC trial completion 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 PoM, SOCA and PoC 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 between the clinical team and partners in the Inflammation and Immunology Research Unit (I&I RU) (Discovery, Pre-clinical and Systems Immunology), Clinical Pharmacology and Bioanalytics, Statistics, and Research and Developments (PRD) teams by maintaining open communications and ensuring successful program transitions. Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders.
• Sit on project teams from FIH/POM/SOCA through POC trial completion 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 PoM, SOCA and PoC 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 between the clinical team and partners in the I&I RU and PRD by maintaining open communications between the two groups and ensuring successful program transitions.
• Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and leaders.
• Coordinate with other clinical research activities in the I&I RU and 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 research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations. Develop effective collaborations with key PRD partners in design of POC studies and develop target clinical goals to benchmark success of POC and SoCA studies. Work on transition team with Late-stage development colleagues to analyze and interpret final POC clinical data in achieving study objectives and develop the phase 3 clinical strategy to support seamless transfer of the asset to the respective Phase3 team. 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 RU 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. QUALIFICATIONSEducation: Requires MD or MD/PhD, Pulmonary specialty required, but other specialists with experience in respiratory clinical trials will be considered. Technical Skills: Experience in generating hypothesis-driven research investigations. Five or more years of experience in biopharmaceutical sponsored clinical research, with a minimum of two in respiratory area. Biopharmaceutical experience as a medical monitor and clinical lead 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. This role is relocation eligibleThe annual base salary for this position ranges from $253,800.00 to $444,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.MedicalSummaryLocation: United States - Massachusetts - CambridgeType: Full time
• Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile.
• Sit on project teams from FIH/POM/SOCA through POC trial completion 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 PoM, SOCA and PoC 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 between the clinical team and partners in the Inflammation and Immunology Research Unit (I&I RU) (Discovery, Pre-clinical and Systems Immunology), Clinical Pharmacology and Bioanalytics, Statistics, and Research and Developments (PRD) teams by maintaining open communications and ensuring successful program transitions. Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders.
• Sit on project teams from FIH/POM/SOCA through POC trial completion 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 PoM, SOCA and PoC 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 between the clinical team and partners in the I&I RU and PRD by maintaining open communications between the two groups and ensuring successful program transitions.
• Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and leaders.
• Coordinate with other clinical research activities in the I&I RU and 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 research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations. Develop effective collaborations with key PRD partners in design of POC studies and develop target clinical goals to benchmark success of POC and SoCA studies. Work on transition team with Late-stage development colleagues to analyze and interpret final POC clinical data in achieving study objectives and develop the phase 3 clinical strategy to support seamless transfer of the asset to the respective Phase3 team. 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 RU 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. QUALIFICATIONSEducation: Requires MD or MD/PhD, Pulmonary specialty required, but other specialists with experience in respiratory clinical trials will be considered. Technical Skills: Experience in generating hypothesis-driven research investigations. Five or more years of experience in biopharmaceutical sponsored clinical research, with a minimum of two in respiratory area. Biopharmaceutical experience as a medical monitor and clinical lead 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. This role is relocation eligibleThe annual base salary for this position ranges from $253,800.00 to $444,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.MedicalSummaryLocation: United States - Massachusetts - CambridgeType: Full time