Pfizer, S.A. de C.V
Director , Clinical Research (MD required)- Immunology, and Inflammation
Pfizer, S.A. de C.V, Cambridge, Massachusetts, us, 02140
Director, Clinical Research (MD required) - Immunology and Inflammation
United States - Massachusetts - Cambridge We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. The purpose of the 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
Immunology and Inflammation
programs. ROLE RESPONSIBILITIES The Director of Clinical Research will be responsible for the following: 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. Develop a network of consultants and KOLs for programs in new indications. 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) by maintaining open communications and ensuring successful program transitions. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas. 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 the I&I RU portfolio and Business Development activities. QUALIFICATIONS Education:
Requires MD or MD/PhD,
specialists with experience in Rheumatology, Allergy, Pulmonary, Hematology, and Dermatology clinical trials will be considered. Technical Skills: Experience in generating hypothesis-driven research investigations. Two or more years
of experience in biopharmaceutical sponsored clinical research. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable. Good understanding or willingness to expand knowledge in 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 eligible . The annual base salary for this position ranges from $213,500.00 to $355,800.00. 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, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage. EEO & Employment Eligibility Pfizer 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.
#J-18808-Ljbffr
United States - Massachusetts - Cambridge We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. The purpose of the 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
Immunology and Inflammation
programs. ROLE RESPONSIBILITIES The Director of Clinical Research will be responsible for the following: 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. Develop a network of consultants and KOLs for programs in new indications. 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) by maintaining open communications and ensuring successful program transitions. Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas. 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 the I&I RU portfolio and Business Development activities. QUALIFICATIONS Education:
Requires MD or MD/PhD,
specialists with experience in Rheumatology, Allergy, Pulmonary, Hematology, and Dermatology clinical trials will be considered. Technical Skills: Experience in generating hypothesis-driven research investigations. Two or more years
of experience in biopharmaceutical sponsored clinical research. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable. Good understanding or willingness to expand knowledge in 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 eligible . The annual base salary for this position ranges from $213,500.00 to $355,800.00. 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, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage. EEO & Employment Eligibility Pfizer 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.
#J-18808-Ljbffr