Remote Director, Nonclinical Development

Spectraforce Technologies; Raleigh (NC); On-site; USD 160,000 - 260,000; Full time

Job summary

Spectraforce Technologies is seeking a Director, Nonclinical Development to provide scientific leadership across women's health, general medicines, and biosimilars. You will guide nonclinical strategy, author regulatory modules, and collaborate with regulatory affairs, safety, CMC, and medical affairs to support global submissions.

This remote, 12-month assignment emphasizes cross-functional leadership, risk assessment, and ensuring GLP/GCP compliance while driving lifecycle management and

Qualifications

• Master's or doctoral degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• 10+ years of pharmaceutical/biotech industry experience with nonclinical disciplines.
• Experience reviewing and authoring nonclinical sections of regulatory dossiers and interacting with agencies.

Responsibilities

• Serve as the nonclinical representative on asset development teams (ADTs) for life-cycle management.
• Author/review nonclinical CTD modules, briefing books, regulatory communications for regional/global submissions.
• Act as nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities across Women's Health, General Medicines and Biosimilars portfolios.

Skills

Nonclinical expertise

Toxicology

Pharmacology

DMPK

Regulatory dossiers

Leadership

Communication

Global collaboration

GLP/GCP knowledge

Education

Master's/PhD or equivalent

Job description

Spectraforce Technologies is seeking a Director, Nonclinical Development to provide scientific leadership across women's health, general medicines, and biosimilars. You will guide nonclinical strategy, author regulatory modules, and collaborate with regulatory affairs, safety, CMC, and medical affairs to support global submissions.

This remote, 12-month assignment emphasizes cross-functional leadership, risk assessment, and ensuring GLP/GCP compliance while driving lifecycle management and