Senior Vice President, Clinical Development

About the role

This position provides strategic and scientific leadership for clinical programs, setting the clinical strategy for approved products and engaging with programs at all stages. The role involves leading the design, planning, and execution of clinical trials, ensuring compliance with regulatory and quality standards, company timelines, and budgets. The position also serves as a thought partner with the leadership team on clinical development strategies.

Responsibilities

• Lead the development and execution of clinical development plans to drive programs through clinical studies, ensuring strategic alignment with company goals.
• Serve as the top representative for clinical development and medical strategy, both internally and externally.
• Lead the Clinical Development team in collaboration with cross-functional teams such as Clinical Operations, Biostatistics, and Regulatory.
• Provide strategic input on new indications and opportunities for antibodies in development or entering the clinic.
• Collaborate with the Research team to identify novel targets.
• Write or facilitate the creation of clinical project management documents, including study protocols, safety plans, recruitment plans, and closeout plans.
• Coordinate with Clinical Operations on the execution of clinical studies, including investigator and vendor management, site monitoring, and data review.
• Review and approve monitoring reports and follow-up letters prepared by project CRAs.
• Plan and review clinical data analysis in collaboration with the Data Science group to determine results interpretation.
• Ensure trials are "audit ready" at all times, addressing audit observations promptly.
• Develop and maintain project schedules with key metrics to ensure optimal study management.
• Identify and resolve issues impacting project scope, resources, or timelines, and communicate them to senior management.
• Develop and monitor the clinical development budget for assigned projects, managing resources, funding, and expenses.
• Assist with tracking and forecasting resource capacity and utilization.
• Provide therapy area medical and scientific expertise to study teams and stakeholders.
• Anticipate trends in medicine and industry that may impact the clinical or commercial viability of products.
• Serve as the principal medical monitor overseeing safety monitoring in clinical development programs.
• Prepare clinical sections of regulatory documents such as investigator brochures, INDs, NDAs, BLAs, and background packages for FDA meetings.
• Provide medical review and approval of regulatory documents.
• Cultivate collaborations with key opinion leaders, investigators, research centers, and corporate partners.
• Collaborate with Business Development, Senior R&D, and Commercial leadership to identify and develop strategic alliances, partnerships, and licensing opportunities.
• Engage and inspire the clinical development team by communicating the strategic vision and operational plan.
• Supervise employees in the Clinical Development Department, including hiring, training, performance appraisal, and conflict resolution.

Requirements

• MD and active US medical license, with 15+ years of clinical drug development experience in the research and development of novel biologics.
• Expertise in preclinical, translational, and early clinical development.
• Extensive academic and pharma collaborative network.
• Proven track record of program leadership, goal achievement, and effective collaboration in team settings.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook), Adobe, and Internet Explorer.

Qualifications

• Firm understanding of the mechanistic basis of human inflammatory disorders.
• Thorough knowledge of clinical protocols, regulatory processes, and the drug development lifecycle.
• In-depth understanding of FDA requirements, Good Clinical Practices, and pharmaceutical clinical development.
• Demonstrated success in establishing, communicating, and driving a vision and strategy for a therapeutic area or product.
• Recognized as a leader and scientific contributor within the therapeutic area, both internally and externally.
• Ability to think strategically about the future of disease states and therapeutic agents, with a solid understanding of the pharmaceutical industry, competition, and commercial aspects such as Marketing, Sales, Market Access, and Business Development.

Skills

• Effective communication and interpersonal skills, with the ability to articulate strategies and results to diverse stakeholders.
• Ability to work effectively in a matrix team environment and build morale and commitment to goals.
• Strong decision-making skills, including sound judgment and timely execution.
• Innovative thinking and resourcefulness in addressing challenges.
• Ability to define issues, analyze complex data, and draw valid conclusions.
• Strategic adaptability to changing conditions and market dynamics.

Physical Demands

The role requires regular sitting, talking, and hearing, with frequent use of hands for typing and handling documents. Occasional standing, walking, and reaching may be required, along with the ability to lift up to 10 pounds. Specific vision abilities include close vision and the ability to adjust focus for reading.

Work Environment

The work is typically performed in an office environment with moderate noise levels. Domestic and international travel may be required, up to 20% of the time.

Pay

Salary range: $306,000–$459,000 per year, with a 35% bonus, 10% 401k match, and equity in the form of options and RSUs.