Responsibilities:
- Collaborate on clinical development strategies for immuno-oncology programs.
- Act as a program-level physician for phase I/II clinical trials.
- Ensure trials adhere to ethical and safety standards and regulatory requirements.
- Contribute to medical content in protocol development and amendments.
- Oversee medical monitoring teams and liaise with CROs.
- Interpret trial results, write medical sections in documents, and contribute to publications.
- Stay updated on advances in the field through literature and KOL relationships.
- Participate in advisory boards, business development, and portfolio decisions.
- Engage with regulatory authorities and assist with protocol submissions.
- Collaborate with data management and statistics teams for trial data analysis.
Experience and Qualifications:
- Medical degree (M.D. or equivalent).
- More than 5 years of pharma experience, including experience with monoclonal antibodies.
- Board Certification, Eligibility, or fellowship training in Oncology.
- Strong experience in clinical report writing and publishing.
- Understanding of pharmacokinetics, pharmacodynamics, and pre-clinical studies.
- Specialized training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.
Competencies, Skills, and Behaviors:
- Experience in medical monitoring of phase I/II clinical studies.
- Proficiency in protocol writing and submission to regulatory authorities.
- Strong communication skills in English.
- Experience in FDA/EMA communication.
- Training in statistics or clinical trial methodology.
- Motivated and dynamic with excellent interpersonal and presentation skills.
- Innovative problem-solving and decision-making abilities.
- Results-oriented with strong organizational and time management skills.
- Ability to lead and manage teams.
- Comfortable challenging the status quo and proposing innovative solutions.
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