Senior Director of Clinical Research

4 weeks ago


Cambridge, Massachusetts, United States Pfizer Full time
Job Summary

The Senior Director of Clinical Research will lead the development of first-in-man, proof-of-mechanism, and proof-of-concept studies for novel biological and small molecule therapies in respiratory disease programs.

Key Responsibilities
  • Develop disease-specific global networks of investigators and key opinion leaders for trial design, management, and recruitment.
  • Design and implement proof-of-mechanism, proof-of-concept, and dose-ranging studies in collaboration with Pfizer development operations and project teams.
  • Develop primary and secondary endpoints for efficacy and safety, and contribute to precision medicine and biomarker strategies.
  • Provide leadership in the preparation of critical documents, including clinical protocols, development plans, and regulatory documents.
  • Collaborate with cross-functional teams, including biostatistics, clinical pharmacology, and regulatory affairs, to ensure seamless transition of assets to late-stage development.
Requirements
  • MD or MD/PhD degree with a pulmonary specialty required.
  • Five or more years of experience in biopharmaceutical-sponsored clinical research, with a minimum of two years in respiratory area.
  • Experience as a medical monitor and clinical lead across therapeutic areas is desirable.
  • Good understanding of biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics, and biomarker-based approaches.
Benefits

Pfizer offers a comprehensive benefits package, including a 401(k) plan, paid vacation, holiday, and personal days, paid caregiver/parental and medical leave, and health benefits.



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