A science-driven research and clinical development organization headquartered in Menlo Park, CA is seeking an Executive Medical Director / VP of Clinical Development to join their team. The well-funded Biotech Company is focused on fundamentally transforming how we approach and treat inflammatory and autoimmune diseases.

Scope and Responsibilities:

They are seeking a dynamic and experienced clinician to join their team in driving the clinical development strategy for our innovative immunology product. The Vice President/Executive Director drives the design, safety monitoring, and data analysis of the Company’s clinical trials. As such, the Vice President/Executive Medical Director is an important leader within the clinical development team. This person will be instrumental in providing medical leadership, strategic direction, and clinical expertise to support the advancement of their pipeline. The ideal candidate will have a strong background in medicine, recognized expertise in their therapeutic area and exceptional leadership abilities, and a passion for driving innovation and excellence in a start-up biotech company. The Vice President/Executive Medical Director will report to the Chief Medical Officer.

Clinical Development: Lead the design, execution, and interpretation of clinical trials in immunology indications to support the development and regulatory approval of our biotech products. Additional activities will include medical monitoring, publication planning, and key opinion leader engagement. Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
Cross-functional Collaboration: Collaborate closely with cross-functional teams, including research and clinical operations, regulatory affairs, and Finance, to integrate medical insights into product development and pipeline strategies.
Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines throughout the product lifecycle, including interactions with regulatory agencies and participation in regulatory submissions.
Medical Monitoring: Medical monitoring of clinical trials; Oversee pharmacovigilance activities and ensure the timely evaluation and management of safety-related issues for our biotech products.
Scientific Leadership: Provide scientific leadership and guidance to internal teams and external stakeholders, including investigators, key opinion leaders, and scientific advisors.
Strategic Planning: Contribute to the development and execution of strategic plans and initiatives to maximize the value and impact of our biotech portfolio.
Team Leadership: Lead consultants, fostering a culture of collaboration, innovation, and excellence.
Stakeholder Engagement: Build and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societies.

Key Selection Criteria:

MD with experience in immunology/autoimmune indications, ideally in rheumatology.
Minimum of 5-10 years of clinical development experience; small to midsize biotech company experience preferred.
A deep understanding of FDA regulations.
Proven track record of leadership in Phase 2 and Phase 3 clinical trials, including trial design and medical monitoring.
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations.
Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitigate risks.
Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
Willingness to be both a strategic leader and hands-on problem solver.
Strong ability to communicate and establish effective working relationships with investigators, collaborators, scientific advisors, CROs, and corporate partners.
Able to work in a small, nimble organization across key functions.
Willingness to travel up to 20% of the time.

Why Join?

A culture inspired by our values: (e.g., patients first, teamwork, scientific rigor and curiosity)
A collaborative, data-driven pre-IPO start-up environment where we inspire each other to always perform at our best and focus on advancing science that will help patients
Learning and development resources to help you grow professionally and potential for advancement for stronger performers
Competitive compensation (Base & Performance Bonus) and stock option package (equity in an early-stage company)
Rich medical, dental, and vision insurance plans
Health, Limited, and Dependent Care FSA; HSA with company contributions
401(k) with company matching
Pre-Tax Commuter Benefits
Paid Term Life and AD&D, STD, and LTD plans
Employee Assistance Program (EAP)
Generous company paid holidays and flexible PTO
Flexible work schedule. Onsite/hybrid preferred;. Remote work will be considered, but will require frequent travel to corporate headquarters.(on-site/hybrid/ remote)
Kitchen stocked with a variety of healthy and delicious snacks and drinks
Free electric car charging on site

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Executive Medical Director / VP of Clinical Development