Full-Time Senior Director, Clinical Development

Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to clinical development activities. Responsibilities include leading strategic planning and execution of clinical development plans, supporting regulatory submissions, and contributing to/leading the medical/clinical affairs plan.

The candidate will work cross-functionally to gather input from internal stakeholders, key opinion leaders, and clinical sites. They will also be responsible for establishing, implementing, and maintaining departmental policies, procedures, and strategies aligned with GCP and ISO 14155.

Key Responsibilities:

1. Collaborate with SVP of Medical & Clinical Affairs, Medical Directors, MSLs, R&D, Sales & Marketing Heads, Global Marketing, Quality & Regulatory, and Health Economics.
2. Ensure scientific rigor in clinical trial design, conduct, validity, and interpretation.
3. Identify project-impacting issues and implement contingency plans.
4. Provide clinical/scientific input throughout trials (protocol development, review & interpretation of results, clinical study report).
5. Offer medical expertise to external groups (field medical team, medical information, commercial organization, advisors, payers, professional organizations).
6. Oversee global trial implementation (execution plan approval).
7. Manage trial metrics (patient recruitment, expenditure, compliance, safety reporting).
8. Approve investigator site selection.
9. Coordinate clinical operations activities and regulatory/ethics submissions.
10. Manage Clinical Operations by providing direction to Clinical Research Managers and Medical Managers.
11. Develop and manage the Clinical Affairs budget.
12. Approve CRO and other vendors.
13. Prepare regulatory agency reports.
14. Mentor clinical research personnel.
15. Understand legal and compliance environment and collaborate with the Legal & Compliance team.
16. Collaborate with functional areas to achieve corporate goals.
17. Ensure consistent application of performance expectations globally.
18. Make resource allocation projections and decisions.
19. Manage assigned clinical program(s).
20. Participate in due diligence activities.

Qualifications:

• 10+ years clinical research experience (multinational experience preferred).
• Advanced degree (MD, PhD, PharmD) required.
• Proven leadership and team growth experience.
• Experience in interventional oncology, radiopharmaceuticals, and interventional radiology preferred.
• Excellent communication, interpersonal, and scientific data presentation skills.
• Medical Device and/or Biopharmaceutical trial experience preferred.
• Monitoring experience (3-5 years) and CCRA preferred.
• Strong GCP, ICH, ISO, and regulatory knowledge.
• Excellent project management, risk assessment, and contingency planning skills.
• Data management experience and budget management.
• Experience with all phases of clinical trials and FDA approval.
• IT office software proficiency.

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