Executive Director, Clinical Development Oncology - SK Life Science, Inc.

The Executive Director of Clinical Development Oncology is a key leadership role responsible for overseeing the clinical development of oncology programs. This position involves strategic planning, execution, and management of clinical trials, ensuring they meet regulatory requirements and company objectives. The Executive Director will lead a team of clinical development professionals and collaborate with internal and external stakeholders to advance the oncology pipeline.

1. Strategic Leadership:
• Develop and execute clinical development strategies for oncology programs.
• Align clinical trial designs and objectives with overall business goals and regulatory guidelines.
• Contribute to the long-term planning and prioritization of the oncology portfolio.
2. Clinical Trial Management:
• Oversee the design, initiation, and conduct of clinical trials (Phase I-IV) in oncology.
• Ensure clinical trials are executed on time, within budget, and in compliance with regulatory and quality standards.
• Monitor clinical trial progress, address issues, and implement corrective actions as needed.
3. Team Leadership and Development:
• Lead, mentor, and develop a team of clinical development professionals, including clinical project managers, scientists, and operations staff.
• Foster a collaborative and high-performing team environment.
• Provide guidance on career development and performance improvement.
4. Regulatory and Compliance:
• Ensure clinical programs comply with regulatory requirements, including those of the FDA, EMA, and other global health authorities.
• Oversee the preparation and submission of regulatory documents, such as INDs, NDAs, and MAAs.
• Serve as a key point of contact for regulatory agencies on clinical development matters.
5. Stakeholder Collaboration:
• Work closely with internal stakeholders, including research, medical affairs, regulatory affairs, and commercial teams.
• Engage with external stakeholders, such as key opinion leaders, clinical investigators, and industry partners.
• Represent the company at scientific and regulatory meetings, conferences, and advisory boards.
6. Budget and Resource Management:
• Develop and manage clinical development budgets for oncology programs.
• Ensure optimal allocation and utilization of resources.
• Manage relationships with external vendors, CROs, and other partners.
7. Scientific and Clinical Expertise:
• Stay current with scientific advancements and clinical trends in oncology.
• Provide scientific and clinical insights to support business development and strategic planning.
• Contribute to the publication of clinical trial results in scientific journals and presentations at conferences.

• MD degree in a relevant scientific discipline.
• Extensive experience (8-10+ years) in clinical development, with a focus on oncology.
• Demonstrated success in leading and managing clinical development programs and regulatory submissions.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Excellent leadership, communication, and interpersonal skills.
• Strong strategic thinking and problem-solving capabilities.
• Ability to thrive in a fast-paced, dynamic environment.
• Experience in a biopharmaceutical or biotechnology company is preferred.