Demo

Senior Medical Director

Withers & Wagg
Boston, MA Full Time
POSTED ON 2/16/2025
AVAILABLE BEFORE 5/14/2025

Company Overview :

Our client is a biopharmaceutical company who develops advanced antibody and vaccine treatments for cancer and infectious diseases. Their unique technology combines multiple biological components for increased effectiveness, working on treatments for various cancers and major viral diseases. Founded by leading medical innovators with a track record of successful breakthroughs, our client provides you the opportunity to learn from truly some of the best in the business.

Role Summary :

The Medical Director will be an integral member of the clinical development teams, driving the collaborative development and execution of clinical strategies for the immuno-oncology programs they have ongoing. This role involves critical responsibilities in clinical study medical monitoring and building collaborative relationships with trial investigators and key opinion leaders. The ideal candidate will possess excellent medical judgment, communication, collaboration, and leadership skills, along with a strong understanding of business principles and cultural awareness.

Key Responsibilities :

  • Medical Monitoring : Provide medical oversight for ongoing clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results. Collaborate with the study team to prepare, review, and complete clinical study and safety documentation
  • Clinical Strategy : Contribute to the development and execution of comprehensive clinical development plans for immune-oncology programs. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications
  • Clinical Trial Design : Contribute to the design and oversight of clinical trials, develop study protocols, review operational documents (e.g., case report forms, monitoring manuals, informed consent documents), and ensure trials are conducted in compliance with regulatory standards and ethical guidelines
  • Health Authority Engagement : Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs
  • Key Opinion Leader Engagement : Build and maintain strong relationships with key opinion leaders and academic institutions to support the company's scientific and clinical objectives
  • Cross-Functional Collaboration : Work closely with other departments such as research and development, clinical operations, and regulatory affairs to ensure alignment and execution on program objectives
  • Communications and Publications : Present clinical trial study and patient updates to internal and external stakeholders. Contribute to the development of scientific publications, presentations, and educational materials

Qualifications :

  • Medical degree (MD) with at least 5 years of drug development experience in the pharmaceutical or biotechnology environment
  • Experience in oncology drug development, including the development of biologics, is required. Experience in infectious disease drug development is a bonus
  • Knowledge of regulatory requirements and experience interacting with regulatory agencies
  • Ability to contribute effectively and independently as a subject matter expert and as part of a cross-functional team
  • Excellent verbal and written communication skills
  • Strong analytical and problem-solving abilities
  • Proven track record of successful clinical trial design and execution
  • Exceptional leadership and interpersonal skills
  • Preferred Qualifications :

  • Board certification in the US, haematology-oncology preferred
  • Experience in translational medicine and biomarker development
  • Salary Range : $300,000 - $350,000

    Location : Hybrid, 3 days in the office

    If you’re interested in being part of a team dedicated fighting cancer and infectious diseases. Apply below!

    Salary : $300,000 - $350,000

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