Chief Medical Officer, Aro Biotherapeutics

Aro Biotherapeutics is seeking an outstanding physician-scientist to join its Senior Leadership Team as Chief Medical Officer (CMO). The CMO will work collaboratively with other senior and functional leaders to produce integrated development strategies and to drive program prioritization. They will have direct responsibility for leading, designing, and building the Aro development organization to support Aro's pipeline. This includes responsibility for clinical operations and project management, as well as leading and working collaboratively with expert consultants in core development functions (including regulatory, clinical pharmacology, nonclinical safety and bioanalysis). Additionally, the CMO will establish and maintain relationships with leading KOLs and establish Aro's approach for active patient advocacy relationships.

• MD or MD/PhD with depth in rare diseases; experience developing genetic medicines is ideal.
• Full-scale early and late-stage clinical development experience, including depth in molecular science and translational medicine.
• Experience with design and clinical oversight of pivotal Ph2/3 adaptive registrational trials is ideal.
• Documented success in advancing therapeutic programs into the clinic and designing creative trials.
• Substantial experience interacting with regulatory agencies and various external stakeholders.

COMPANY OVERVIEW

Founded in 2018, Aro Biotherapeutics is a privately-held biotechnology company pioneering the development of tissue-targeted genetic medicines with a platform based on a proprietary protein technology called Centyrins. The company is developing a wholly owned pipeline of Centyrin-based therapeutic candidates and is leveraging Centyrins to deliver siRNAs that are designed to address disease related genes at their source.

THE POSITION

Key responsibilities include:

Phase 1b - Open Label study in LOPD patients (n=4) in Canada

1. Oversees site selection and clin/reg strategy to support enrollment in conjunction with the CRO (expect 2-3 sites).
2. Provides ABX1100 and study overview to CROs, investigators, KOLs and other key stakeholders as needed to support enrollment.
3. Weekly meetings with Aro Regulatory and the Clinical Development Working Group to execute integrated plan, monitor safety data and evaluate PK/PD data as available.

Oversees Clinical/Regulatory forward planning for the ABX1100 program

1. Clinical/Medical support for all CTA/IND submissions and timelines.
2. IND submission planned for 4Q 2024 to expand Phase 1b to the US.
3. Pre-IND mtg early 2025 to support pivotal Ph2/3 planning.
4. Develops Clin/Reg strategy to support design and enrollment of the Phase 2/3 program, choice and timing of clinical endpoints, PK/PD endpoints, safety monitoring, patient population, pediatric development plan.
5. Maintenance of Orphan Drug Designation and consideration for Fast-track and/or Breakthrough Therapy designations.

CEO support

1. Support CEO in contributing to company strategy, communication plan and hiring plans.
2. Participate in Aro's Board of Directors quarterly meetings.
3. Support equity Financing activities including investor meetings and diligence activities.
4. Work with CEO and BD team to support potential partnering opportunities.

Mentor and develop leaders at all levels and maintain strong, collaborative relationships across the organization.

The ideal candidate will have the following mix of personal and professional characteristics:

• MD or MD/PhD with depth in rare diseases; experience developing genetic medicines is ideal.
• Full-scale early and late-stage clinical development experience, including depth in molecular science and translational medicine.
• Experience with design and clinical oversight of pivotal Ph2/3 adaptive registrational trials is ideal.
• Documented success in advancing therapeutic programs into the clinic and designing creative trials.
• Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task to thrive in a small, fast-paced company.
• Substantial experience interacting with regulatory agencies and various external stakeholders.
• Self-starter who works with a sense of urgency and is a strong, cross-functional team player.
• Patient focused, creative, and passionate with a strong work ethic.
• Entrepreneurial thinking and actions, including the ability to identify challenges and concurrently offer solutions.
• Outstanding written and verbal communication skills; including marked proficiency in clinical/medical writing.
• Strong leadership and excellent interpersonal skills; high emotional intelligence to enable favorable group dynamics and influence others at all levels.