Job details
Kelly® Science & Clinical is seeking a Clinical Development Medical Director for a fulltime, direct hire position with a pharmaceutical client in the San Francisco Bay Area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
(No C2C)
Title: Medical Director
Reports to: CMO
Flexible Hybrid: 2-3 times per month in the beginning, less often later on
Strongly prefer: Infectious Disease/Antiviral clinical development experience (HBV)
Travel: 20% (domestic and international)
Job Summary: The Medical Director will play a critical role in shaping and executing the clinical strategy for our product pipeline. This leadership position involves strategic planning, clinical trial design, and cross-functional collaboration to advance our clinical programs from clinical development through regulatory approval.
Key Responsibilities:
- Clinical Strategy: Lead the development and execution of clinical strategies for Company’s product pipeline in alignment with corporate objectives. Stay up-to-date with evolving industry trends, clinical guidelines, and regulatory standards, integrating them into the company’s clinical development strategies.
- Trial Design: Design and oversee clinical trials, including protocol development and patient recruitment strategies, to ensure scientific robustness and operational feasibility.
- Trial Execution: Provide medical and scientific leadership in the execution of clinical programs, working closely with clinical operations to ensure successful trial implementation, monitoring, and completion.
- Regulatory Submissions: Collaborate with Regulatory Affairs to ensure that clinical development programs meet global regulatory requirements and are prepared for regulatory submissions. Lead the preparation of clinical sections of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and New Drug Applications (NDA).
- Cross-Functional Collaboration: Work closely with Research, Regulatory, and Commercial teams to ensure cohesive development and commercialization strategies.
- Medical Monitoring: Provide medical oversight and monitoring for clinical trials, ensuring patient safety and data integrity.
- Stakeholder Engagement: Act as a liaison with investigators, key opinion leaders, regulatory agencies, and other external stakeholders to advance clinical programs and gather insights.
- Data Analysis and Interpretation: Lead the clinical interpretation of study data and present findings to internal and external stakeholders, including at conferences and scientific meetings.
- Team Leadership: Mentor and lead clinical development team members, fostering a collaborative and innovative work environment.
- Publications and Presentations: Contribute to the preparation and review of publications and presentations for internal and external stakeholders.
- Business Development: Support business development activities by providing medical and scientific insights for potential new products or partnerships.
Qualifications:
- Education: MD or equivalent medical degree; board certification in a relevant specialty, Infectious Diseases preferred.
- Experience: Minimum of 5-7 years of clinical development experience in the biotech or pharmaceutical industry. Proven track record of successful clinical trial design and execution, including experience in leading programs from early development through regulatory approval.
- Regulatory Knowledge: In-depth knowledge of regulatory requirements and guidelines for clinical development and regulatory submissions.
- Leadership Skills: Demonstrated leadership experience with the ability to influence and lead cross-functional teams.
- Communication: Excellent verbal and written communication skills with the ability to present complex data clearly to diverse audiences.
- Analytical Skills: Strong analytical and problem-solving skills with a data-driven approach to make informed decisions based on scientific and medical evidence.
- Passion for Innovation: A strong commitment to innovation and patient-centered care.