R

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Associate Director - Clinical Scientist, Immunology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$176.1k - $287.3k /yr

About the Job

Requirements

  • An advanced degree or equivalent education/degree in life science or healthcare is preferred (PhD, PharmD, or MSc).
  • At least 10 years of pharmaceutical clinical drug development experience.
  • Proficient knowledge of the drug development process, Good Clinical Practice, study design, and clinical research methodology, with solid medical writing skills.
  • Experience in all aspects of conducting global clinical trials and executing clinical programs.
  • Ability to influence within the team and potentially cross-functionally in a matrix organization.

Responsibilities

  • Contribute to the development, evaluation, planning, and execution of Internal Medicine clinical studies, ensuring scientific integrity and interpretation of study data for a clinical development program.
  • Work in a matrix environment as part of a cross-functional team, including internal and external vendor representation, and contribute to candidate development projects through early and/or late-phase development.
  • Function as the Clinical Scientist for a program and/or as delegate of the Therapeutic Area Clinical Scientist.
  • Contribute to program team meetings, scientific advisory boards, study steering committees, and data and safety monitoring meetings; represent the function in collaborative activities with other departments as appropriate.
  • Maintain proficient understanding of therapeutic disease areas and drug candidates, including disease biology, clinical manifestations, therapeutic standards of practice, mechanisms of action, and the drug landscape.
  • Use scientific expertise to propose, design, and execute clinical research and development studies for early- and/or late-stage assets, and develop strategy proposals grounded in supporting literature.
  • Develop the Expanded Synopsis; author clinically relevant sections; review other scientific portions of clinical trial protocols and amendments.
  • Author and/or review trial documents, including medical monitoring plans, statistical analysis plans, informed consents, and clinical components of Clinical Study Reports; support regulatory document development, perform quality review, approve documents as applicable, and adjudicate and resolve cross-functional comments with minimal support.
  • Contribute to planning and prepare information for external and stakeholder meetings, including internal medicine, governance, data monitoring committees, and regulatory authorities; present data and information to external investigators at site initiation visits and to internal collaborators.
  • Apply analytical knowledge to understand how program objectives and design affect data analysis, identify risks, and design mitigation strategies.
  • Promote consistent first-line medical and clinical data review techniques and conventions across studies and programs; review clinical data review plans and author medical monitoring plans for assigned studies or programs.

Desired Qualifications

  • Experience in Immunology clinical trials.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

Recently Posted Jobs

Explore more opportunities at Regeneron Pharmaceuticals

See more jobs