Senior Director, Clinical Science

About the Role

The Senior Director, Clinical Science is a strategic scientific leader responsible for shaping clinical development strategy, overseeing clinical study design, and directing the interpretation of clinical data across one or more development programs. This individual serves as a key partner to Clinical Science leadership and is accountable for advancing innovative therapies through critical development milestones, including proof-of-concept, registrational studies, regulatory submissions, and lifecycle management.

Responsibilities

• Clinical Development and Portfolio Leadership
  • Provide strategic leadership for one or more clinical development programs, ensuring alignment with corporate objectives and long-term portfolio strategy.
  • Drive integrated development strategies across multiple studies and indications, including registration-enabling and lifecycle management activities.
  • Serve as the Clinical Science representative to governance committees, development review boards, and senior leadership teams.
  • Influence key program decisions, including indication prioritization, dose selection, endpoint development and validation, regulatory submission strategy, and benefit-risk assessment.
  • Partner with key functional stakeholders (e.g., Clinical Science physicians, Operations, Data Management, Regulatory Affairs, and Executive Leadership) to define and optimize development pathways.
  • Evaluate scientific, clinical, competitive, and regulatory developments to identify opportunities and risks impacting development strategies.
• Clinical Study Design Oversight
  • Provide strategic oversight for study design across a portfolio of clinical programs.
  • Guide development of innovative clinical trial designs, endpoint strategies, biomarker approaches, and patient selection methodologies.
  • Ensure protocols support regulatory, scientific, and commercial objectives while maintaining operational feasibility.
  • Champion incorporation of translational science, patient-reported outcomes, and precision medicine approaches into development programs.
  • Review and approve critical study design decisions, protocols, amendments, and key study documents developed by Clinical Science teams.
  • Partner with Clinical Science physicians and cross-functional stakeholders to ensure studies address key development questions and support regulatory objectives.
• Strategic Clinical Data Leadership
  • Lead interpretation of integrated efficacy, safety, biomarker, PK/PD, immunogenicity, and translational datasets across studies and programs.
  • Drive benefit-risk assessments and provide strategic recommendations that influence major development and portfolio decisions.
  • Lead cross-functional data review activities and provide clear scientific guidance to project teams and senior leadership.
  • Present clinical findings, development strategies, and recommendations to Executive Leadership, governance committees, and external stakeholders.
  • Ensure clinical data are translated into actionable insights supporting regulatory strategy, asset differentiation, and future development planning.
  • Identify emerging risks and opportunities and drive proactive mitigation strategies.
• Regulatory and Health Authority Strategy
  • Provide strategic leadership for clinical components of global regulatory submissions, including INDs, CTAs, Investigator Brochures, Clinical Study Reports, briefing packages, and marketing applications.
  • Contribute to regulatory strategy and support interactions with global health authorities, including FDA, EMA, and other regulatory agencies.
  • Guide clinical positioning to maximize the probability of regulatory success.
  • Support preparation for regulatory meetings, inspections, and advisory committee activities.
  • Contribute clinical expertise to due diligence activities, business development opportunities, and strategic partnerships.
• External Scientific Leadership
  • Develop and maintain relationships with key opinion leaders, investigators, academic collaborators, and scientific advisors.
  • Represent the company at major scientific congresses, advisory boards, and external scientific forums.
  • Shape publication strategies and oversee clinical support of abstracts, manuscripts, presentations, and scientific communications.
  • Monitor advancements in Immunology and related therapeutic areas and assess implications for company programs and portfolio strategy.
• Organizational and People Leadership
  • Lead, mentor, and develop Directors, Associate Directors, and (Senior) Clinical Scientists.
  • Build organizational capabilities and establish Clinical Science best practices that support a growing biotechnology organization.
  • Contribute to workforce planning, succession planning, and talent development initiatives.
  • Foster a culture of scientific excellence, accountability, innovation, and collaboration.
  • Promote effective cross-functional partnership and serve as a trusted scientific advisor across the organization.

Qualifications

• Advanced degree in a scientific, healthcare, or related discipline preferred (e.g., PhD, PharmD, MD, DO, MS, MPH, NP, PA, or equivalent).
• 15+ years of clinical research, clinical development, or clinical science experience within the biotechnology, pharmaceutical, or CRO industry.
• Significant experience leading Clinical Science activities across Phase 1 through Phase 3 clinical development programs.
• Demonstrated expertise in clinical study design, protocol development, and interpretation of complex clinical datasets.
• Proven success influencing clinical development strategy and advancing programs through major development milestones, including proof-of-concept, registrational studies, and regulatory submissions.
• Experience supporting global regulatory submissions and health authority interactions.
• Demonstrated ability to present development recommendations to Executive Leadership and governance committees.
• Prior people leadership experience with responsibility for developing managers and senior scientific staff.

Pay

The expected base salary for this position is $203,157.00 to $263,841.00. Compensation includes base salary, annual discretionary bonus, long-term incentive, and 401(K) plan with employer contribution.

Benefits

• Health care and other insurance benefits (for employee and family).
• Paid holidays, vacation, and sick days.

A summary of benefits can be found on the company's careers page.