Medical Director, Infectious Disease Clin Dev
1 week ago
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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