Contact: Deloris Jones for more details djones@kbic.com 617-639-0681
Role: Medical Director/Senior Medical Director, Clinical Development (Consultant)
Reports to: CMO
Location: REMOTE – HQ in South San Francisco
Company Overview: Our client is a clinical-stage biotechnology company based in South San Francisco, CA.
Position Summary
The Senior Medical Director will play a crucial role in guiding the clinical development of our cell therapy programs. This position requires an individual with strong epilepsy expertise to provide strategic insights, support clinical trial design and data oversight, and ensure regulatory compliance. The ideal candidate will have a solid foundation in clinical epilepsy care and research and a keen interest in driving medical innovation.
Position Duties and Responsibilities
- Clinical Development Leadership: Support the design, execution, and analysis of
clinical trials, ensuring alignment with regulatory standards and scientific integrity.
- Epilepsy Expertise: Apply clinical expertise in epilepsy to study design, execution, and
monitoring, as well as data analysis and interpretation to enhance the quality and
impact of our clinical research.
- Regulatory Compliance: Ensure all clinical activities comply with FDA, EMA, and other
regulatory agency guidelines, maintaining high standards of quality and ethics.
- Cross-functional Collaboration: Work closely with research, regulatory affairs, clinical
operations, and other departments to drive project success.
- Strategic Planning: Contribute to the strategic planning and execution of clinical
programs, providing insights to support decision-making.
- Data Management: Oversee the collection, management, and analysis of clinical data,
ensuring accuracy, consistency, and completeness.
- Stakeholder Communication: Communicate effectively with internal and external
stakeholders
- Training and Mentorship: Provide training and mentorship to junior staff and team
members, fostering a culture of continuous learning and improvement.
- Innovation and Improvement: Identify opportunities for process improvements and
implement innovative solutions to enhance clinical trial efficiency and effectiveness.
- Travel: Up to 25% travel may be required to attend study cases and conferences, meet
with collaborators and oversee clinical sites.
Skills, Education, and Experience Required
- Education: MD or equivalent medical degree with completed fellowship in epilepsy or
related field.
- Experience: Relevant clinical and research experience, ideally gained during
fellowship, with a focus on epilepsy.
- Knowledge: Strong understanding of clinical trial design, regulatory requirements, and
epidemiological research methods.
- Skills: Excellent analytical, organizational, and communication skills, with the ability to
manage multiple projects and priorities effectively.
- Collaboration: Ability to work collaboratively in a fast-paced, cross-functional
environment.
- Leadership: Demonstrated leadership potential and a commitment to driving medical
innovation and improving patient outcomes.
- Passion: A genuine interest in cell therapy and a commitment to advancing medical
science.
This job description is not exhaustive and not intended to cover all activities of the position.
Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
