Executive Director – Clinical Development

Executive Director – Clinical Development

Requirements

• MD, PhD or similar biomedical graduate degree with 8 or more years experience in pharmaceutical/biotech industry
• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry
• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development
• Experience authoring and clinical development strategy(ies) and bringing forward for governance
• Extensive understanding 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 experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s)
• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills, with the ability to inspire, motivate and mentor a diverse team
• Expertise in building and maintaining strong relationships with internal and external stakeholders
• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals
• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required
• Proven ability to manage budgets and timelines effectively
• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients’ lives.

Responsibilities

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives
• Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence
• 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
• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones
• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development
• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals
• Manage multiple direct reports; potentially be a manager of managers.

Preferred Qualifications

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry
• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization
• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus
• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.
• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs
• Direct experience with Phase IV drug development
• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally
• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders – including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. – resulting in demonstrable outcomes (e.g. new study proposals or new disease indications)
• Has demonstrated courage and conviction in past positions and responsibilities. Skilled in conflict resolution.