Senior Medical Director, Early-Stage Clinical Development

ng regulatory submissions, driving the development of transformative therapies for patients.

Practice Info
• Clinical-stage precision oncology company
• Focus on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers
• R&D pipeline comprises RAS(ON) Inhibitors and RAS Companion Inhibitors
• 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)

Responsibilities
• Lead clinical science and medical aspects of the clinical development strategy and clinical documentation, representing the clinical development plan on appropriate teams, sub-teams and forums.
• Oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, and oversee the conduct of medical/safety data reviews and study reporting.
• Perform responsibilities with independence and clear self-directed leadership for complex and high-priority strategic studies.
• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.
• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals.
• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.
• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.
• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

Compensation
• Base Pay Salary Range: $244,000-$305,000
• competitive cash compensation
• robust equity awards

Benefits
• strong benefits
• significant learning and development opportunities

Requirements
• MD (oncology training preferred) with 7+ years of experience in clinical development in the pharmaceutical/biotech industry and/or academic/other clinical trial setting; some experience in and understanding of early phase drug development preferred.
• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.
• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.
• 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 is required.
• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.
• 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.
• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements.
• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).
• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.