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Biogen

Develops therapies for neurological disorders

Associate Medical Director - Clinical Development, Immunology

Clinical Research OperationsPosted on Nov 13
Full-time

About the Job

Requirements

  • A board-certified or board-eligible MD/DO (or equivalent), MD/PhD, or PharmD with relevant experience is required.
  • The candidate must have 1–2+ years of experience in the biotechnology or pharmaceutical industry, with additional experience in clinical research.
  • The candidate must have prior experience in medical monitoring or as an investigator or sub-investigator.
  • The candidate must have experience contributing to clinical study execution and/or oversight and working cross-functionally with research and development partners.
  • The candidate must be able to communicate effectively in writing and verbally.
  • The candidate must be able to manage multiple priorities in a fast-paced environment.
  • The candidate must be able to travel domestically and internationally as required for business needs.

Responsibilities

  • Partner with cross-functional teams, including Clinical Pharmacology, Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety, to advance early-phase drug development programs.
  • Contribute to clinical trial protocol design, development, and execution for early-phase studies.
  • Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety.
  • Serve as a key contact for contract research organizations and investigators, responding to protocol-related questions.
  • Provide scientific expertise to internal and external stakeholders.
  • Support data interpretation and clinical reporting for early-phase clinical studies.
  • Support preparation for health authority interactions and contribute to responses to regulatory questions related to clinical development activities.
  • Support risk-mitigation strategies and provide clinical input for safety management plans.
  • Provide content for clinical study documents, including protocols, amendments, investigator brochures, clinical study reports, and briefing materials.
  • Champion patient-centered drug development by incorporating disease burden, feasibility, and patient experience considerations into study design.

Desired Qualifications

  • Subspecialty experience in nephrology or autoimmune disorders, or prior drug development experience in nephrology or autoimmune diseases, is strongly preferred.
  • Relevant disease-area experience, such as experience with immune-mediated conditions, is preferred.
  • Understanding of regulatory requirements for drug development is preferred.
  • An established network of Key Medical Experts and Key Opinion Leaders is preferred.

About the Company

Biogen

Develops therapies for neurological disorders

Biogen is a global biotechnology company focused on neuroscience. It discovers, develops, and delivers therapies for neurological disorders, such as multiple sclerosis and other neurodegenerative diseases. Its product process starts with research and development to identify potential drugs, followed by clinical testing and regulatory approval, ultimately leading to commercialization and patient treatment. Biogen differentiates itself through a long history (founded in 1978), a deep specialization in neuroscience, and an integrated pipeline that moves ideas from discovery to approved medicines, aiming to create value for shareholders while helping communities. The company’s goal is to advance therapies for neurological diseases to improve patients’ lives and generate sustainable value for stakeholders.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
1978

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