Microbiome Jobs in Minnesota (NOW HIRING)

As a privately-owned,biopharmaceutical company, Ferringpioneers anddeliverslife-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, whileremainingagile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

The Head of Clinical Development & Biometrics provides strategic and operational leadership across clinical development, clinical operations, and biometrics functions. The role blends clinical leadership with data-driven decision-making to deliver high-quality evidence from early clinical studies through Phase 2, with a strong emphasis on fit-for-purpose trial design, robust analysis, regulatory readiness, strong governance, and efficient outsourcing in a small microbiome-focused biotechnology environment. The role is also responsible for the People Leadership of the Microbiome Clinical Development & Biometrics Team.

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:

• Lead global clinical development and clinical operations strategy across the microbiome pipeline through Phase 2 and 3

• Provide 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

• Build scalable processes, governance, and high-performing teams to support efficient and high-quality development execution

Requirements:

• Years of Experience: Minimum10-15+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: Operateswith a high strategic autonomy in a lean biotech environment.

• Innovation: Advanced trial design, microbiome-specific endpoints, and data-driven methodologies.

• Key Stakeholders: Strategic leadership, executive communication, and regulatory interactions across internal and external stakeholders. Internal: Executive leadership, R&D, Regulatory, QA, Clinical Operations, Medical, and Commercial. Also responsible for leading and coaching team. External: Regulatory authorities, CRO's, vendors, advisors, and investigators.