R&D Project Manager, Nonclinical Development

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Description:

Pangea Bio discovers and develops transformative medicines to treat neurological disorders with large unmet medical need. We deploy AI to discover promising molecules from natural sources, such as plants, with evidence of safety and efficacy in humans based on traditional medicinal use. Nature offers great potential to uncover novel medicines: 84% of central nervous system small-molecule therapeutics are nature-inspired with less than 1% of nature's small molecules having been mapped and explored. To tap into this vast potential, we utilize AI to identify neuroactive molecules from medicinal plants which we subsequently optimise into clinical candidates.

Our lead R&D program focuses on the TrkB receptor pathway - a pivotal regulator of neuroplasticity - which drives synaptic plasticity, neuronal survival, and reduces pathological protein aggregates. Our first candidate molecule, a proprietary small molecule activating the TrkB receptor, will enter clinical trials in 2025. This compound shows compelling pre-clinical data across schizophrenia, Alzheimer's disease and Parkinson's disease. In addition, we are developing our drug discovery pipeline to tackle a range of neurological conditions.

Our team has a successful track record of building CNS-focused biotech and technology companies including COMPASS Pathways (Nasdaq: CMPS), GW Pharmaceuticals (acquired by Jazz Pharmaceuticals), atai Life Sciences (Nasdaq: ATAI), and Healx.

Due to a maternity leave, we are seeking an experienced R&D project manager with expertise in clinical formulation development, regulatory writing and nonclinical project management for 12 months.

The initial primary objective for the candidate is to deliver the drug product for the lead compound's Phase 1 clinical study, and in collaboration with the team further develop the regulatory package for the Phase 1 study, and prepare the Phase 2-enabling activities. The successful candidate will thus play a pivotal role in enabling the start and execution of the Phase 1 clinical study.

Roles and responsibilities

Responsibilities include (but are not limited to):

• Operational lead to deliver the clinical formulation of the lead compound to enable regulatory submission in Q2 2025 and subsequent earliest start for the Phase 1 clinical trial
• Generation of regulatory documentation (IB and IMPD) in collaboration with external partners and the internal team to enable regulatory filing and obtain regulatory approval
• Manage the nonclinical development of the lead compound including project planning and execution of nonclinical safety pharmacology and toxicology studies and CMC activities, ensuring adherence to timelines, budgets, reporting and quality standards
• Provide formulation, CMC and Phase 1-enabling expertise to early R&D programs to support progression
• Collaborate with cross-functional teams and key stakeholders, internally and externally, as well as executive leadership team members to ensure a smooth transition from pre-clinical to clinical studies

Required experience, skills

• Advanced degree in chemistry, life sciences, or related field; MSc or PhD strongly preferred.
• Minimum of 5 years industry experience in nonclinical development of small molecules focused ideally on first-in-human clinical formulation development for orally administered small molecules
• Working knowledge and experience in regulatory document writing for MHRA and EMA
• Experience in leading, creating or contributing to IB and IMPD documentation
• Experience in planning and delivering Phase 1 and Phase 2-enabling CMC and safety pharmacology and toxicology data packages
• Exceptional project management skills in biotech / pharma environment
• Strong communication and interpersonal skills, including collaboration, and ability to drive nonclinical projects independently
• A passion and sense of urgency to deliver novel therapies to treat patients in need

This is an opportunity to join a fast-paced entrepreneurial environment, where you will have a significant influence on company strategy and performance. The compensation package will include base salary and benefits.

How to apply

If interested, please apply via our Bamboo HR system. You must have the right to work either in the UK or Germany to apply for this role.

We aim to be an equal opportunities employer and we are determined to ensure that no applicant or employee receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements which cannot be shown to be justifiable.

Please note: We are not accepting submissions from Recruitment Agencies for this position - any candidates submitted will not be accepted by or on behalf of Pangea Bio.