Senior Director of Nonclinical

The RFT Group; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

The RFT Group is helping a biotech client hire a Senior Director of Nonclinical to lead non-clinical development strategy from development through registration. The role interfaces with health authorities, serving as the company toxicology representative for FDA/EMA interactions and safety discussions.

Key responsibilities include leading toxicology and safety pharmacology, coordinating external experts, and shaping non-clinical safety strategies for regulatory submissions while supporting

Qualifications

• PhD, MSc or equivalent BSc degree in Toxicology or Pharmacology with 10+ years related experience. Neuroscience experience preferred.
• Excellent medical/scientific writing skills.
• Proven ability to interact with external partners/experts.
• Experience in cross-functional influence and project leadership.

Responsibilities

• Provide senior scientific leadership across toxicology, safety pharmacology, translational safety assessment, and regulatory non-clinical activities.
• Interface with health authorities as the company toxicology representative and address questions from FDA, EMA and other authorities on nonclinical safety topics.
• Oversee external research organizations and scientific experts; develop integrated non-clinical safety strategies.
• Lead specialised safety assessment programmes and prepare non-clinical content for global regulatory submissions and health authority interactions.

Education

PhD/MSc/BSc in Toxicology or Pharmacology

Job description

Our client, a young Biotech company with an exciting pipeline in Neuroscience, now have approval to hire a Senior Director of Nonclinical. This hire will lead the non-clinical development strategy supporting the advancement of innovative therapies from development through registration.

This hire will be the interface with health authorities acting as the company toxicology representative and addresses questions in interactions with FDA, EMA and otherauthorities on nonclinical safety topics.

The successful candidate will provide senior scientific leadership across toxicology, safety pharmacology, translational safety assessment, and regulatory non-clinical activities, ensuring that non-clinical programmes effectively support clinical development and health authority interactions.

Additionally, you will have responsibility for oversight of external research organisations and scientific experts, development of integrated non-clinical safety strategies, leadership of specialised safety assessment programmes, and preparation of non-clinical content for global regulatory submissions and interactions with health authorities.

Depth of toxicology expertise and experience with various modalities and routes of administration through to NDAs, MAAs, etc. is highly desirable.

This is a full-time permanent role, with flexibility on salary / level depending on candidate with attractive package for the right candidate. This employee will have flexibility for remote working from their home office in the US, with occasional meetings in HQ when required.

Requirements include:

• PhD, MSc or equivalent BSc degree in the areas Toxicology or Pharmacology, with 10+ years related experience. Neuroscience experience is preferred.
• Professional toxicological registration, ERT, UKRT or DABT is preferable.
• Experience of toxicological risk assessment of impurities, extractables and leachables is beneficial but not essential.
• Depth of experienced in pharmaceutical toxicology and possesses knowledge of the relevant regulatory guidelines and preparation of submission documentation.
• Proven experience with NDA and MAA submissions is advantageous.
• Excellent medical / scientific writing skills.
• Proven ability to interact with and seek input from external partners/experts.
• Experience in working and influencing cross-functionally.
• Flexible, able to adjust, embrace and drive change.