Director Clinical Development

Senior Director, Clinical Development – Immunology / Autoimmune

Lead the Decisions That Define an Autoimmune Program

We are partnering with a science-driven, growth-stage biotech advancing innovative therapies for autoimmune and immune-mediated diseases—areas of profound unmet need and rapidly evolving clinical science. As the organization transitions from proof-of-concept into pivotal development, we are seeking a Senior Director of Clinical Development to help shape the clinical, regulatory, and strategic path forward.

This is a rare opportunity to step into a role where clinical judgment truly matters. You will be entrusted with guiding late-stage decisions that directly influence probability of success, regulatory outcomes, and long-term value creation—while working in a lean environment that values rigor, clarity, and scientific debate.

The Role

As Senior Director, Clinical Development, you will provide end-to-end clinical leadership for one or more immunology/autoimmune programs spanning Phase II and Phase III. You will be deeply involved in translating emerging data into decisive development strategies, ensuring programs are positioned for regulatory success while remaining clinically meaningful for patients and physicians.

You will serve as a key scientific leader across the organization—partnering closely with Clinical Operations, Regulatory, Biometrics, Medical Affairs, and senior leadership—while helping build the clinical development function as the pipeline matures.

Key Responsibilities

Clinical & Strategic Leadership

• Lead clinical development strategy for late-stage immunology/autoimmune assets, including indication prioritization, endpoint strategy, and lifecycle planning
• Translate Phase II data into Phase III-ready development plans, supporting investment decisions and portfolio prioritization
• Serve as the clinical lead on cross-functional program teams, providing clear scientific direction and balanced risk assessment
• Ensure benefit–risk profiles are thoughtfully articulated and supported by robust clinical evidence

Regulatory & External Engagement

• Partner with Regulatory Affairs to prepare for and participate in health authority interactions (e.g., End-of-Phase II, Scientific Advice, pre-BLA/MAA)
• Contribute to briefing documents, responses, and regulatory strategy with a strong understanding of late-stage expectations
• Engage with KOLs, investigators, and advisory boards to refine development plans and external scientific positioning

Execution & Oversight

• Provide clinical oversight of protocol development, safety monitoring, and data interpretation across studies
• Collaborate with Clinical Operations to ensure trials are operationally feasible, patient-centric, and globally scalable
• Work closely with Biometrics to interpret data and guide decision-making at key milestones

Medical & Evidence Alignment

• Partner with Medical Affairs to ensure alignment between late-stage development, evidence generation, and future medical needs
• Contribute to integrated evidence planning, ensuring clinical data supports long-term value, access, and durability narratives

People & Culture

• Mentor and develop clinical scientists and physicians, helping build a strong, accountable clinical development team
• Foster a culture of scientific rigor, transparency, and thoughtful decision-making in a fast-moving biotech environment

Who You Are

You are a seasoned clinical development leader with deep expertise in immunology or autoimmune disease, and a track record of guiding programs through complex, high-stakes development phases. You are comfortable operating in ambiguity, making evidence-based decisions, and taking ownership in an environment where resources are focused and impact is visible.

Qualifications

• MD, DO, or PhD (MD strongly preferred)
• 10+ years of experience in clinical development within biotech or pharma
• Demonstrated leadership of Phase II and/or Phase III programs in immunology/autoimmune indications (e.g., lupus, RA, IBD, MS, dermatology, or related immune-mediated diseases)
• Strong understanding of late-stage trial design, regulatory expectations, and clinical risk management
• Experience working in lean or growth-stage organizations preferred
• Prior people leadership or strong mentoring experience highly valued

Why This Opportunity Is Compelling

• True ownership of late-stage clinical strategy in a biotech setting
• Opportunity to influence programs with potential to change standards of care in autoimmune disease
• Close partnership with executive leadership and direct exposure to key decision-makers
• Ability to help shape not just programs, but the clinical development function itself
• Competitive compensation, meaningful equity participation, and long-term upside

Location & Flexibility

This role is based in New Jersey with a hybrid working model, offering flexibility while maintaining strong in-person collaboration during critical development milestones.