Your new company
You'll be joining an innovative biotech company who are further expanding their team after a large funding round is expanding to support the Clinical Development of their pipeline as they move their lead asset into Phase 1 trials. You'll be joining a highly experienced team and helping to push their projects through clinical studies.
The company has a flexible working set-up and so the role can have a strong home-based element, and a highly collaborative working environment.
Your new role
You'll be an integral part of the Research team, taking responsibility for a number of aspects surrounding late stage R&D and early clinical development for multiple assets.
- You'll be responsible for providing scientific support to define the clinical development strategy and select indications for pipeline assets.
- Your role includes collating competitive scientific landscape information, offering scientific input on dose selection and clinical pharmacology planning.
- As part of your responsibilities, you'll lead the development of clinical trial synopses, collaborate with various functions, and stay up-to-date with industry trends in autoimmune disease research and clinical trial design.
- Additionally, you'll take the lead in developing biomarker strategies, establish strong relationships with key opinion leaders, and oversee data analysis and interpretation.
- Regulatory Contributions: You'll contribute from a scientific standpoint to the development and review of regulatory submission documentation, ensuring compliance with FDA and EMA regulations.
- Supporting trial design: Liaising with Clinical Operations, Regulatory and R&D teams, you will provide scientific oversight of clinical protocols & trial design, as well as feeding into endpoints
- Your role also involves working with colleagues to ensure patient safety throughout the clinical trial process. You'll help evaluate adverse events and work with Clinical Operations, PV and CRO teams to implement safety measures as needed.
- Cross-Functional Collaboration: Collaborate with preclinical research, translational medicine, and commercial teams; as well as managing external consultants and vendors.
What you'll need to succeed
You should have:
- A deep understanding of the immunology space (preferably within autoimmunity, though this is a 'nice to have' rather than a pre-requisite)
- A BSc or above (or equivalent experience) within a life sciences subject, eg pharmacology, biochemistry, biology, chemistry or similar, with a preference for a higher degree (MSc / PhD) or medical degree / MD
- A track record of supporting clinical trials and/or development plans, from a scientific standpoint, eg by supporting dosage calculations or designing Phase 1 studies
- Excellent communication and organisational skills, ideally with a history of managing/liaising with outsourced providers
- Good understanding of regulatory requirements around clinical development / clinical trials
What you'll get in return
As well as a highly collaborative and flexible working environment, you'll have the chance to help define structure and processes for a growing biotech and help them make a real impact as they move their drug candidates through the clinical pipeline.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Keywords: R&D, clinical, research, trial, drug, development, preclinical, CMC, regulatory, business, launch, leadership, delivery, biotech, pharmaceutical, CRO, project, program, programme, Director, PK, PD, dosage, pharmacology, autoimmune, immunology