Job title: Director Clinical Development
Company: Barrington James
Job Description: Director, Clinical Development (Oncology)
Reports To: Chief Medical Officer
We are seeking a highly motivated and experienced Director of Clinical Development with a specialization in Oncology to lead and drive our clinical development programs. The Director will play a key role in advancing our pipeline of Oncology therapies, managing clinical trials, and contributing to the strategic development of our Oncology portfolio.
- Clinical Strategy: Develop and implement the clinical development strategy for our Oncology programs, including phase I-III trials, to ensure successful regulatory submissions and commercialization.
- Clinical Trial Design: Lead the design of clinical trials, including protocol development, selection of endpoints, and determination of appropriate patient populations.
- Regulatory Affairs: Collaborate with regulatory affairs to ensure compliance with regulatory requirements and provide guidance on clinical trial applications and approvals.
- Cross-functional Collaboration: Work closely with cross-functional teams, including medical affairs, clinical operations, and data management, to drive the execution of clinical trials.
- KOL Engagement: Establish and maintain relationships with key opinion leaders in Oncology, collaborating on advisory boards and gathering expert input for study design and data interpretation.
- Data Analysis and Interpretation: Oversee data analysis, interpretation, and preparation of clinical study reports and publications. Contribute to the development of regulatory documents.
- Risk Management: Develop and implement risk management strategies for clinical trials, identifying potential challenges and mitigating risks to ensure trial success.
- Budget Management: Manage the clinical development budget, including forecasting and tracking expenses for assigned projects.
- Personnel Management: Provide leadership and mentorship to clinical development teams, including Clinical Project Managers and Clinical Research Scientists.
- Continuous Learning: Stay up-to-date with the latest developments in Oncology research and clinical trial design, ensuring that the organization remains at the forefront of the field.
- Medical Doctor (MD) or PhD in a relevant field, with board certification in Oncology or a related discipline.
- Proven experience in clinical development, with at least 4 years of experience in Oncology drug development.
- Strong knowledge of regulatory requirements for Oncology clinical trials and drug development (FDA, EMA, etc.).
- Demonstrated experience in leading cross-functional teams and managing clinical development projects.
- Excellent interpersonal and communication skills, with the ability to build and maintain relationships with external partners, investigators, and KOLs.
- Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.
- Proficiency in project management, including budget management and resource allocation.
- A track record of successful regulatory submissions and approvals in the Oncology field is highly desirable.
- An entrepreneurial mindset with a strong drive for innovation and the ability to adapt to a rapidly changing clinical development landscape.