Senior Director Clinical Development, Solid Tumor

Accountabilities:

• • Lead clinical development strategy and create comprehensive clinical development plans that address worldwide regulatory, clinical, commercial, and patient-access considerations for assigned partnership programs.
  • Provide senior clinical and scientific leadership across development programs, ensuring studies are appropriately planned, executed, and delivered within required quality, scope, and timelines.
  • Partner closely with cross-functional program teams and execution units to support seamless implementation and high-quality delivery of clinical studies.
  • Provide scientific expertise in the selection of investigators, vendors, CROs, and other external partners.
  • Offer ongoing medical and scientific guidance throughout clinical trial conduct and serve as a senior escalation point for asset-related clinical issues.
  • Review, analyze, interpret, and communicate clinical trial data for internal decision-making and external presentations.
  • Build and maintain strong relationships with investigators and key opinion leaders and lead advisory boards, investigator meetings, and other scientific engagements.
  • Author, review, and oversee key clinical development documents, including protocols, amendments, informed consent documents, Investigator Brochures, clinical study reports, abstracts, manuscripts, and clinical sections of regulatory submissions.
  • Provide clinical input into INDs and equivalent applications, NDAs and equivalent submissions, annual reports, safety updates, health authority briefing materials, orphan drug applications, risk-benefit assessments, and clinical development plans.
  • Respond to clinical and scientific questions from investigators, CROs, clinical monitors, regulatory authorities, and other stakeholders regarding study design, data analysis, and interpretation.
  • Provide therapeutic-area training and guidance to execution teams, CRO personnel, and study sites, while coaching and mentoring clinical development colleagues.
  • Conduct regular program reviews with execution teams and partnership stakeholders to assess study progress, operational KPIs, quality metrics, risks, and timelines.
  • Contribute to therapeutic-area research, competitive intelligence, indication assessments, and broader clinical development strategy.
  • Promote a global approach to clinical development, encouraging consistency, collaboration, continuous improvement, and effective knowledge sharing across teams.
  • Manage and develop direct reports, including Medical Directors and Clinical Scientists supporting assigned programs.
  • Participate in organizational standards, processes, and policy development and perform additional strategic responsibilities as required.

  Requirements:

  • MD, DO, or equivalent medical degree in a relevant discipline.
  • At least 6 years of clinical development experience, including 5 or more years focused on oncology; 10+ years of relevant experience is preferred.
  • Deep professional knowledge of oncology therapeutics, with strong understanding of solid tumors and a deep understanding of immuno-oncology highly desirable.
  • Demonstrated experience developing and executing clinical development strategies and plans across global programs.
  • Strong understanding of international clinical development regulations, compliance requirements, and health authority expectations.
  • Experience working effectively in a global, cross-functional environment with internal teams, CROs, investigators, regulatory agencies, and external partners.
  • Proven ability to analyze and interpret clinical data and translate scientific findings into development strategy and business recommendations.
  • Experience developing clinical and regulatory documentation, including protocols, clinical study reports, regulatory submissions, and related materials.
  • Demonstrated ability to build productive relationships with investigators, key opinion leaders, advisory boards, and other external scientific stakeholders.
  • Strategic leadership experience, including the ability to build, manage, mentor, and develop high-performing clinical development teams.
  • Strong project management, prioritization, and decision-making capabilities, with the ability to manage multiple programs and competing priorities.
  • Excellent written and verbal English communication skills, with the ability to present complex scientific information clearly to diverse audiences.
  • Strong analytical thinking, data interpretation, collaboration, initiative, and results-oriented mindset.
  • Ability to embrace change, operate with an entrepreneurial mindset, and navigate an evolving global development environment.
  • Proficiency with Microsoft Office and standard business productivity tools.
  • Willingness and ability to travel domestically and internationally, up to approximately 20%.

  Benefits:

  • Base salary range of $299,800–$369,800 per year, with actual compensation determined by experience, skills, education, certifications, and work location.
  • Eligibility for an annual bonus or incentive compensation program, depending on role classification and performance.
  • Eligibility for discretionary equity awards and participation in an Employee Stock Purchase Plan.
  • Comprehensive medical, dental, and vision coverage.
  • 401(k) retirement plan.
  • Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
  • Life insurance coverage.
  • Paid time off.
  • Wellness benefits and programs supporting employee well-being.
  • Remote work opportunity within the United States.
  • Opportunity to work on innovative oncology development programs within a global, cross-functional clinical development environment.
  • Up to 20% domestic and international travel, providing opportunities for scientific and professional engagement.