SVP Clinical Development - Remote Position

Role Summary

The Senior Vice President, Clinical Development will direct the clinical development program of the company’s drug candidates across multiple indications, contributing to the selection of oncology indications to pursue and helping to determine the overall development strategy. They will oversee the Clinical Development organization, including translational, clinical sciences, program management, external medical directors, and possibly biometrics. The role includes defining and implementing a system for peer scientific review of standards of care, new study concepts, and final clinical protocols, and providing clinical-technical input into regulatory submissions aligned with development and commercialization objectives.

Responsibilities

• Managing, building, and leading clinical development teams to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements
• Playing a key role in defining “go/no-go” decision points, timelines and resources in alignment with the research and development goals and objectives of the collective as well as individual indications
• Defining and executing clinical development strategy in the context of financial and market environments, articulating opportunities and threats, and evaluating options against commercial and scientific trends
• Maintaining strong relationships with key external stakeholders and partners (KOLs, investigators, vendors, consultants, patient advocacy groups, and other trial participants) to meet program goals
• Leading medical monitoring activities including acting as primary point of contact for day-to-day medical guidance for trial staff and for regulatory, safety and clinical operations
• Providing clinical and medical guidance in collaboration with the medical affairs team for IST studies, conference strategy, Advisory Boards, medical education, publications, and related projects
• Leading strategic clinical development plans, including literature review, protocol development, regulatory briefing document preparation, investigator meeting preparation, CCR, abstracts, presentations, and manuscripts
• Identifying and evaluating scientific, licensing, partnership, alliance, and outsourcing opportunities
• Preparing presentations to the Board of Directors and Advisory Committees; communicating clinical information to technical and non-technical audiences for investor and customer engagement

Qualifications

• Must have a solid understanding of oncology and/or hematology drug development and life-cycle management
• Full working knowledge of Good Clinical Practice guidelines; familiarity with PhRMA code of conduct and regulatory guidelines for Phase IV activities
• Experience in planning and execution of clinical trials and investigator-sponsored trials
• Ability to interpret and explain scientific research and dissemination of clinical data
• Experience supervising technical and managerial staff; senior management experience
• Excellent oral and written communication and interpersonal skills
• Strong leadership, team building, negotiation, and execution abilities
• Ability to manage multiple projects in a fast-paced environment
• Ability to cultivate and maintain relationships with thought leaders and establish scientific credibility
• Willingness to travel within the US and internationally as required

Skills

• Oncology/hematology drug development expertise
• Regulatory and clinical trial planning expertise
• Strategic leadership and cross-functional collaboration
• Medical monitoring and trial oversight
• Effective communication to technical and non-technical audiences
• Relationship building with external stakeholders

Education

• Advanced Life Science Degree (MD, MD/PhD, DO or equivalent) strongly preferred
• Extensive clinical development experience in lieu of listed education may be considered
• Board Certification in oncology preferred

Experience

• 5-10 years of related international clinical development experience with a mix of corporate and academic experience
• Experience in Oncology strongly preferred
• Experience in Breast Cancer and/or Small Cell Lung Cancer preferred

Additional Requirements

• Willingness to travel within the US and internationally as required
• Remote working environment; occasional in-person presence at an office as needed
• Physical demands include extended sitting and computer use; ability to lift up to 25 pounds occasionally