Vice President Clinical Development

Avetix Bio; United States; On-site; USD 240,000 - 320,000; Full time

Job summary

Avetix is seeking an accomplished leader to drive global clinical development programs in rare diseases and gene editing. This role defines strategies, plans, and registration pathways for multiple programs.

You will directly lead Medical and Clinical Operations teams, ensuring high-quality data from concept through NDA/BLA submission, and collaborate with Regulatory, Biometrics, and Pharmacovigilance functions.

Qualifications

• MD or PhD in Clinical Medicine, Pharmacology, or a related life science field is required.
• Solid experience in non-oncology clinical development; immunology, CNS, metabolic, infectious, or rare diseases preferred.
• 10+ years in clinical development within pharma/biotech with global regulatory know-how.

Responsibilities

• Develop, refine, and execute integrated global CDPs for assigned programs and define target product profiles and registration strategies.
• Provide medical and scientific leadership across all phases (I–IV) of clinical development with timely, high-quality study delivery.
• Serve as senior medical monitor and signatory; lead medical review of data and author key regulatory documents (protocols, studies, reports).
• Directly line-manage and mentor Medical and Clinical Operations teams; foster a high-performance culture.
• Lead cross-functional Core Team; collaborate with Biometrics, Regulatory, Pharmacovigilance, CMC, and Commercial; manage overseas components.
• Represent the company with global health authorities (FDA, EMA, NMPA) and engage with KOLs/advisory boards.
• Present data at major scientific conferences and drive data-disclosure strategies in publications.

Education

MD or PhD in Clinical Medicine/Pharmacology/Life Science

Job description

Avetix are partnered with an exiting biotech working in the Rare Disease and Gene Editing space. They are looking for someone who has this experience, but also looking for someone who can really grow and develop a team, with late stage development experience.

Key Responsibilities:

1. Develop, refine, and execute integrated global clinical development plans (CDPs) for assigned programs. Define target product profiles and registration strategies.

2. Provide medical and scientific leadership across all phases (I-IV) of clinical development. Ensure timely and high-quality delivery from protocol concept through study report, regulatory submission, and lifecycle management.

3. Serve as the senior medical monitor and signatory. Lead the medical review and interpretation of clinical data. Author/oversee key documents: protocols, IBs, clinical study reports, and regulatory submission modules (IND/CTA/NDA/BLA).

4. Directly line-manage and mentor a team of Medical and Clinical Operations. Foster a collaborative, high-performance culture. Provide strategic direction and oversight to the team, ensuring close functional alignment.

5. Lead the cross-functional Core Team. Collaborate effectively with Biometrics, Regulatory Affairs, Pharmacovigilance, CMC, and Commercial. Manage overseas/global project components, including liaising with the regulatory bodies, CROs, sites, and internal regional teams.

6. Serve as the primary clinical representative with global health authorities (FDA, EMA, NMPA, etc.). Establish and maintain relationships with global Key Opinion Leaders (KOLs) and advisory boards.

7. Represent the company at major scientific conferences. Lead data disclosure strategy, including publications in high-impact journals.

Qualifications:

1. MD or PhD in Clinical Medicine, Pharmacology, or a related life science field is required.

Solid experience in non-oncology clinical development is essential. Specific experience in immunology, CNS, metabolic, infectious, or rare diseases is highly preferred.

2. Minimum 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements. Strong strategic thinking, problem-solving, and analytical skills.

3. Demonstrated, hands-on experience leading the complete clinical development lifecycle from early-stage to NDA. Excellent project management and organizational abilities.

4. Substantial experience in managing overseas clinical development activities (e.g., US, EU), including direct interaction with the regulators and partners.

5. Proven experience in directly managing and developing teams, including both medical/scientific roles and experience providing matrix leadership or direct oversight to Clinical Operations functions. Strong people management and mentoring skills.

6. Fluent spoken English is mandatory, with the ability to lead international meetings, present complex data, and negotiate effectively.