Executive Director, Head of Translational Sciences & Nonclinical Operations

About the Company

Innovative genetic medicines company

Industry
Biotechnology

Type
Privately Held

Founded
2015

Employees
51-200

Categories

• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Information Technology & Services
• Technology
• Biotechnology
• Biopharma
• Genetics

Specialties

• RNA Therapies
• Genetic Medicines
• Non-Viral Lipid Nanoparticles
• Genetic Respiratory Disease
• Cystic Fibrosis
• Primary Ciliary Dyskinesia
• and Biotechnology

About the Role

The Company is a pioneering genetic medicines organization at the forefront of mRNA and gene correction therapeutics. The Head of Translational Sciences & Nonclinical Operations will be a key leader in driving the nonclinical and translational sciences strategy, ensuring it aligns with clinical development plans, and navigating regulatory pathways to support clinical development and marketing approvals. This role involves overseeing and providing strategic direction for various teams, including toxicology/pathology, bioanalytical/DMPK, biomarkers, and clinical pharmacology, to ensure robust support for clinical development programs. The successful candidate will be responsible for delivering high-quality data packages to regulatory authorities, collaborating with cross-functional teams, and developing strategic plans for nonclinical operations.Applicants must have an advanced degree in life sciences or medicine, with a preference for a PhD, MD, or PharmD, and at least 12 years of experience in the biopharma industry in non-clinical development. A strong understanding of science and drug development, particularly in rare diseases, genetic medicines, gene therapy, and lipid nanoparticles, is highly valued. The role requires comprehensive knowledge of GLP regulations, previous experience in pharmaceutical or biotechnology industry, and a strong knowledge of global regulatory requirements, including FDA (CBER), EMA, MHRA, and other major regulatory authorities. Excellent communication, interpersonal skills, and strong leadership abilities are essential for this position, which also involves fostering collaborations with key opinion leaders and external partners in the field of translational sciences.

Hiring Manager Title
SVP of Early Development

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration