Head of Clinical Development and Biometrics

Responsibilities

Lead global clinical development and clinical operations strategy across the microbiome pipeline through Phase 2 and 3
Promote leadership for clinical operations planning and execution, including study delivery, site oversight, enrollment performance, and operational risk management
Oversee biometrics activities, including development of study protocols, statistical analysis plans, data standards, biostatistics, data management, and programming
Design fit-for-purpose, innovative, and operationally feasible clinical trials
Provide medical and scientific oversight of clinical studies, ensuring alignment with regulatory expectations and evolving microbiome-specific considerations
Ensure the integrity, consistency, and compliance of clinical data in alignment with GCP and regulatory requirements
Interpret clinical and biometrics data to inform program decisions and progression
Manage CROs and vendors to ensure quality, timelines, and budget adherence
Contribute to regulatory strategy and lead clinical and biometrics components of regulatory submissions, including INDs, CTAs, and NDAs/BLAs
Serve as a key liaison with regulatory agencies, external advisors, and CRO partners
Support preparation of briefing documents and participation in health authority meetings

Requirements

Years of Experience: Minimum 10-15+ years of leadership in clinical development, with strong clinical operations and biometrics oversight.
Required Education/Qualifications: Advanced degree (MD, PhD, PharmD or equivalent). Expertise: Clinical development, clinical operations, biometrics, trial design, regulatory requirements, vendor oversight, and microbiome experience preferred.
Communication: Strong communication skills, with the ability to present complex data clearly to executive leadership and external stakeholders.
Judgement: Ability to balance scientific innovation with clinical and regulatory rigor in an emerging field.
Problem Solving: Highly complex and multi-dimensional, integrating clinical, operational, statistical, and microbiome science and trial execution.
Level of Autonomy: Operates with a high strategic autonomy in a lean biotech environment.
Innovation: Advanced trial design, microbiome-specific endpoints, and data-driven methodologies.