Head of Preclinical Development
CHARM Therapeutics is a biotech focused on delivering transformational medicines that will address difficult-to-drug targets in key oncogenic pathways. CHARM has developed the first highly accurate, high throughput protein-ligand co-folding algorithm (DragonFold), driven by end-to-end 3D deep learning. Our platform enables the rapid generation of highly differentiated clinical candidates, our ambition is to revolutionise drug discovery.
CHARM Therapeutics has established a state-of-the-art R&D facility in Cambridge, UK. We are seeking an experienced scientific leader, with a passion for scientific innovation, to lead preclinical development within CHARM. The successful candidate will join a multidisciplinary, highly collaborative drug discovery team to provide scientific and drug development expertise in the areas of toxicology, DMPK and translational sciences. This key leadership position will play a pivotal role in translating AI-driven scientific research into clinical candidates.
Leadership: Provide expert scientific guidance in the fields of toxicology, DMPK, and PK/PD to program teams, ensuring that preclinical packages align with clinical development needs.
Toxicology: Lead the development and execution of a comprehensive and scientifically robust nonclinical safety strategy, from lead identification through the execution of clinical trials. Oversee and interpret studies aimed at assessing clinical candidate toxicities, therapeutic index, and overall risk/benefit evaluation. Provide strategic counsel to project teams, including evaluating the implications of toxicology results on program and clinical/regulatory strategy.
DMPK: In partnership with project teams, support PK/PD and ADME studies to enable portfolio advancement. Devise, implement, and analyse DMPK studies to elucidate metabolic pathways, drug-drug interactions, and transporter interactions. Apply cutting-edge allometric scaling and dose prediction models. Aid the project team in developing the clinical PK and PK/PD plan.
Translational and Biomarker Plan: Contribute to the transition of projects from preclinical to clinical development through robust translational plans.
Regulatory: Oversee the preparation and presentation of relevant sections in external documents such as the Investigator’s Brochure, IND/CTA, PIP, CTD, and more. Review all regulatory and health authority documents for the relevant regulatory agencies.
CRO Selection & Oversight: Take primary responsibility for delivering critical project data through an external network of study providers. Collaborate with project teams to choose Contract Research Organizations (CROs) and actively participate in study design, issue resolution, data analysis and interpretation, quality control/audit, and supervision of study reports.
Flexibility: Must be capable of contributing to a diverse portfolio of projects, spanning the spectrum from early and late preclinical discovery to translational medicine and clinical development.
PhD or equivalent and advanced experience in toxicology, ADME and/or translational sciences
Skills and Experience required:
- Demonstrated leadership skills, with the ability to thrive in a fast-paced environment
- Experience in leading drug discovery and development programs through significant milestones (candidate identification, first-in-human studies, proof-of-concept studies)
- Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA)
- Excellent project management and organisational abilities
- Strong problem-solving and decision-making skills
- Effective communication and collaboration skills
- Experience in oncology drug development is an advantage
- A minimum of 15 years of relevant industry experience in pharma/biotech