Medical Director, Clinical Development

RBW is partnered with a well-funded pre-IPO biotech that is looking to looking to expand their clinical development team after receiving positive data on their NSCLC program. This biotech focuses on solid tumors with programs ranging from phase 1 to pivotal phase 3 and has recently added 5+ solid tumor assets to their pipeline.

Job Summary

Our client is looking to hire an experienced Medical Director / Senior Medical Director Clinical Development to oversee their global pivotal phase 3 Lung Cancer programs. This role will report directly to the VP and will be responsible for the development of clinical research strategies and direction.

This role will oversee the preparation of two solid tumor programs and will begin medical monitoring is Q3 2024.

Job Responsibilities

• Expertise in medical and scientific fields is crucial for the success of clinical trials and development of effective treatments.
• Provide clinical and scientific input for study design, protocol concepts, statistical analysis plans, and reporting to ensure valuable clinical endpoint insight for future decision-making.
• Sound scientific and clinical judgement is essential to interpret clinical trial data accurately.
• Collaboration with external opinion leaders, Principal Investigators, and clinical operations personnel is necessary for successful implementation of appropriately designed studies.
• Developing scientific relationships with external opinion leaders and presenting at advisory boards, scientific meetings, and external committee meetings.
• Participate in the preparation of abstracts, manuscripts, and presentations for external meetings and author clinical sections of regulatory documents (IB, IND sections).
• Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies to ensure compliance.

Qualifications

• MD or Equivalent
• 3+ years of clinical development experience within the pharmaceutical industry
• Experience in oncology with deep experience in NSCLC.
• Someone who is capable and likes to be hands-on in medical monitoring, can work flexible hours, and if they are interested, in clinical development strategies.