Senior Vice President, Clinical Development

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee the clinical strategy, design, and execution for oncology and rare disease initiatives.

• Establish the clinical development strategy, which includes study design, endpoint selection, patient population strategy, and regulatory pathway.

• Direct the design, initiation, and management of both early- and late-stage clinical trials.

• Integrate AI-assisted protocol design, digital enrollment tools, and advanced analytics into the clinical development process.

• Mentor and lead clinical development professionals, including medical directors, clinical scientists, and program leads.

• Facilitate interactions with the FDA and international regulatory agencies, guide IND strategy, and assist with clinical sections of regulatory submissions and responses.

• Collaborate with Clinical Operations to ensure trials are delivered on schedule, within budget, and meet high-quality standards.

• Formulate biomarker strategies, patient selection criteria, and adaptive trial designs.

• Supervise clinical safety monitoring, adverse event reviews, risk management, and interactions with the Independent Data Monitoring Committee.

• Assist in portfolio prioritization, resource allocation, go/no-go decisions, and program risk assessments.

• Represent the organization at scientific conferences, advisory boards, investigator meetings, and key opinion leader engagements.

• Support business development due diligence, partnership discussions, and in-licensing evaluations.

• Provide clinical content for investor communications, earnings calls, KOL events, and R&D days.

⛳️ Requirements

• A minimum of 15 years of clinical development experience, with significant expertise in oncology, rare disease, immunology, or precision medicine within the biotechnology or pharmaceutical sector.

• MD or MD/PhD with a focus on oncology, hematology, rare disease, immunology, or a related biomedical field; an MD or MD/PhD is highly preferred.

• Proven experience leading Phase 1 and Phase 1/2 clinical trials for novel mechanisms, including dose-escalation studies and biomarker-selected populations.

• Direct responsibility for IND filings and clinical development plans is required.

• A strong history of cross-functional program leadership and experience in managing and developing teams of clinical scientists and medical directors.

• Experience or comfort working within a TechBio, data science-driven, or AI-enabled drug development environment.

• An inquisitive mindset regarding the application of AI and digital tools in clinical development is essential.

• Direct experience in engaging with the FDA and other regulatory agencies is required.

• Proven track record in managing development timelines and budgets is necessary.

• Strong scientific knowledge in small molecule drug development, kinase biology, oncology mechanisms of action, or rare disease pathophysiology.

• Exceptional communication and leadership skills are essential.

• Experience in a publicly traded company with investor-facing communications is preferred.

• A strategic mindset combined with a hands-on operational approach is required.

🏝️ Benefits

• Equal Opportunity Employer.

• Accommodations are available upon request for candidates participating in all aspects of the selection process.

• AI-powered Talent Matching tool offers application review support, with human recruiters and hiring managers making all final decisions.