Job Description

Director Medical Monitor Clinical Development

Location

San Carlos, California

Description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

Reporting into the Vice President of Clinical Development (MD), the Director, Medical Monitor, Clinical Development (MD) will be a point person for the medical oversight of clinical studies, with responsibilities to include providing medical input on study plans and execution, sponsor medical monitoring, the review and interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners.

• Provide direct medical monitoring or medical safety oversight of CRO medical monitors.
• Provide clinical input on protocols, IBs, ICFs, INDs, safety reports, monitoring plans, review forms, data edit checks, and data quality planning.
• Provide protocol-specific training to the study team and Investigators.
• Advise the study team on medical issues during risk assessment and mitigation, ensuring quality, compliance, and study participant safety.
• Work with the study team to ensure protocol adherence and data integrity.
• Ensure high-quality data by verifying patient population and adequacy of clinical assessments.
• Review and interpret clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the Clinical Operations and Data Management groups, and make recommendations and determinations as appropriate and required to help ensure the protection of study participants.
• Responsible for the preparation, analysis, and presentation of safety data as part of the Internal Safety Team (IST) and to the Data Safety Monitoring Board (DSMB).
• Ensure compliance with regulatory reporting requirements for safety reporting in conjunction with Regulatory Affairs.
• Represent Vaxcyte externally to trial site Investigators and administrators.
• Comply with Vaxcytes SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Collaborate on topline data reporting and clinical study reports.
• Support the study team in issue resolution, study closeout, audit responses, and inspection readiness.
• Co-author abstracts, posters, presentations, and publications.
• Develop and maintain strong, collaborative relationships with the broader Vaxcyte organization.

• MD (active medical license is preferred) with both early and late-stage drug development experience desired. Minimum of 3 years of industry experience required.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies are desirable.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Strong analytical, problem-solving skills, and strategic planning skills required.
• Must be accurate, detailed and committed to high quality standards and proactive in finding solutions to achieve successful outcomes.
• Highly capable of following organizational plans, goal setting, resource management, contingency planning, coordinating and collaborating with others.
• The ideal candidate will be a results-driven team player and must thrive in a fast-paced, dynamic environment. Must have the ability to drive results, possessing a strong drive to meet and exceed goals and be willing to take ownership of problems and make or recommend sound decisions.

Reports to: Vice President, Clinical Development

Location: San Carlos, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $276,000 $311,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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