Associate Director, Clinical Pharmacology

The Associate Director, Clinical Pharmacology will be responsible the execution of Clinical Pharmacology studies needed to advance the progression of compounds under development.

The above includes supervision or direct involvement in the design and execution of clinical studies supporting the assessment of absorption, distribution, metabolism and excretion (ADME) of drugs in development. In addition, the Associate Director provides direct input to cross functional teams such as providing scientific support and expert consultation to project teams. The Associate Director will present scientific data to internal and external audiences and may be required to provide management to the Clinical Pharmacology team members and deputise for the VP Head of Clinical Pharmacology.

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.

**Location**: Home based in the UK or office based in our London office.

**Reports to**: The Associate Director, Clinical Pharmacology will report to the VP, Head of Clinical Pharmacology.

**Roles and responsibilities**:

- Provides strategic Clinical Pharmacology support and guidance to clinical stage project teams, enabling the team to achieve the optimal product profile for initial and lifecycle formulations and indications
- Provision of clinical pharmacology study expertise (eg study design, protocol concepts/protocol preparation, clinical phase oversight, and reporting) within assigned programmes
- PK/PD insight for future critical decisions. Analyses results, interprets, and recommends action based on study results
- Oversee external vendors in Modelling and Simulation
- Collaboration with Clinicians, Clinical Science Group and Clinical Operations at Compass Pathways to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
- Identification and efficient resolution of programme and study-specific issues
- Working with study and programme teams to achieve programme goals and provides deliverables in approved timeframes
- Responsible for the analysis, interpretation, integration and reporting of clinical pharmacokinetic & PK/PD data internally and in collaboration with external vendors/academic sites
- Working closely with the nonclinical DMPK function, Clinical Sciences and Clinical Operations teams to ensure all aspects of clinical pharmacokinetic studies have sufficient oversight to ensure bioanalytical excellence and highest quality data for our projects
- Preparing appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports, NDA/MAAs with respect to Clinical Pharmacology studies or data and ensuring management and peer review
- Identify and efficiently resolve programme and study-specific issues relating to ADME
- Provide line management to the Clinical Pharmacology team members as necessary
- Create study level documents that include, but is not limited to synopses, protocols, and Informed Consent Documents in collaboration with Clinical Sciences
- Provides strategic Clinical Pharmacology support and guidance to clinical stage project teams
- Attends pertinent internal meetings, including those of the appropriate Study Teams and ad-hoc committees
- Attends and presents at KOL advisory boards, investigator meetings, and regulatory agency meetings, as required
- Acts as the primary point of contact for the study as clinical pharmacology representative (this includes both internal and external contacts) and reports key clinical pharmacology data
- Leads and or/reviews Clinical Pharmacology data analysis and interpretation in preparation for study reports and in preparation of documents for IND and NDA filings
- Participates in the preparation of abstracts and manuscripts for publication with support from Medical Writing
- Closely partner with all Clinical functions, Regulatory, Programme Management, Discovery Research and other departments as required
- Applies best regulatory practices and drug development precedent to assigned programmes
- Supports regulatory filings including CTA/IND, Annual Report/General Investigation Plan, NDA/MAA and supplements/variations
- Plays a vital role in clinical trials, by supporting Clinical Operations Managers and ensuring that the studies are being conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonisation (ICH)
- Responsible for liaising with other applicable research and development functions to