Pfizer Senior Director, Clinical Research in Cambridge, Massachusetts
ROLE SUMMARY
The 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 RESPONSIBILITIES
- 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.
- 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.
- 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.
- 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 Phase 3 team.
- Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks.
QUALIFICATIONS
Education: 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 eligible.
The annual base salary for this position ranges from $253,800.00 to $423,000.00. 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.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer 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.
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.
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