Medical Director, Early-Stage Clinical Development

The Medical Director of Clinical Development will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s). The scope of activities spans early-stage clinical research and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-Designation (BTD) or Accelerated Approvals (AA).

What You Will Do

The Medical Director will lead clinical science and medical aspects of the clinical development strategy and clinical documentation, represent the clinical development plan on appropriate teams, sub-teams, and forums, and oversee the conduct of medical/safety data reviews and study reporting.

Why It Might Be a Fit

The ideal candidate will have a strong orientation to teamwork, excellent leadership, communication, and interpersonal skills, and the ability to inspire, motivate, and mentor across a diverse team. They will also have a passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

Requirements

• MD (oncology training preferred) with 5+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting
• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry
• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills)
• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations
• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process
• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities