Vice President, Clinical Development

Role Summary

Vice President, Clinical Development will lead the clinical development strategy for a program and manage trial strategy and execution across the Clinical Development Team. The role partners with Clinical Operations to collaborate with cross-functional teams internally and externally to ensure the successful development and approval of new therapies.

Responsibilities

• Develop and implement the clinical development strategy for a Program aligned with the company's overall goals and objectives.
• Oversee development of clinical development plans (CDPs) and clinical trials.
• Analyze and interpret clinical trial data including patient data, provide medical direction to teams for execution of protocols, to develop clinical study reports, and in making decisions and/or troubleshooting issues.
• Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials and develop and implement risk management strategies.
• Ensure the scientific integrity of clinical studies and compliance with regulatory requirements.
• Collaborate with regulatory affairs to define the regulatory strategy and provide oversight and expertise in the regulatory submission process (IND, BLA, etc.).
• Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP).
• Lead and manage the clinical development team, provide guidance, mentorship, and professional development opportunities.
• Represent clinical development in executive leadership meetings and contribute to strategic decision-making processes.
• Serve as a medical representative in meetings with regulatory agencies (e.g., FDA, EMA).
• Develop and review scientific content for regulatory documents, scientific communications and marketing materials.
• Provide medical expertise to support product development, marketing, and sales.
• Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs).

Qualifications

• Preferred: MD with a minimum of 15 years' experience with a focus in oncology; or MD/PhD with a minimum of 12 years' experience with a focus in oncology.
• Preferred: Medically licensed, Fellowship and/or Board certification in oncology or hematology.
• Preferred: A minimum of 10 years' experience in clinical development, with substantial experience in the pharmaceutical industry leading successful clinical programs.
• Preferred: Proven experience in Phase 1 clinical programs.

Skills

• In-depth knowledge of clinical trial design, execution, and regulatory.
• Demonstrated exceptional strategic thinking and problem-solving skills.
• Excellent leadership and team management abilities.
• Strong communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.