The Principal Research Scientist, Bioanalysis will be responsible for ensuring the delivery of Bioanalytical contributions to drug development programmes at COMPASS. The role will involve extensive interaction between COMPASS team members, CROs and our external collaborators.
COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com.
Location: United Kingdom (Home or Office based).
Reports to: The Principal Research Scientist will report to Preclinical ADME Director.
Roles and responsibilities
Main responsibilities include (but are not limited to):
- Serve as the bioanalytical subject-matter expert on cross-functional drug discovery and development project teams
- Manage outsourced study activities with CROs, including contracting and test item logistics, to ensure timely delivery of data and reports
- Provide scientific and quality oversight of CROs to facilitate the development, validation and transfer where necessary of GxP bioanalytical methods
- Work with internal stakeholders (e.g. ADME, Toxicology, Discovery Pharmacology) to build development plans for early phase drug development efforts
- Ensure communication between ADME and Toxicology team members to modify plans and deliverables according to latest regulatory knowledge and strategy
- Communicate to Preclinical ADME Director about risks, issues and possible mitigation (planned and unforeseen) of bioanalytical studies
- Present and discuss data to internal and external collaborators
- Oversee all aspects of regulatory enabling studies from study design, study plan/phase plan generation, method development and validation and sample analysis, through to report review and finalisation (including SEND and CTD submission) for pivotal and non-pivotal studies
- Contribute to the preparation of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and address relevant queries from regulatory agencies
- BSc, MSc or PhD in chemistry, analytical sciences, pharmaceutical sciences, or a related field
- Extensive experience in the pharmaceutical industry supporting bioanalysis in non-clinical and clinical studies
- Extensive experience developing and validating bioanalytical methods for small molecules
- Experience preparing bioanalytical sections of regulatory submission documents (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols
- Strong knowledge in GLP/GCP regulations and regulatory guidance documents that apply to bioanalysis
- Excellent written and oral communication skills
- Excellent leadership skills
- Demonstrated ability to effectively influence without authority in a matrix organisation
Proven ability to prioritise and deploy resources appropriately to align with project and corporate objectives
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.