Life Science People are a strategic growth partner within the Life Science industry providing bespoke services to the life science community from SMEs through to blue chip organisations and sourcing the best talent to make a tangible contribution to healthcare.
Life Science People is retained exclusively with a start-up Biotech specialising in developing innovative therapeutic solutions in rare and auto-immune diseases.
In this role, you will lead the strategic planning and management of the assigned clinical program from an end-to-end clinical development perspective. You will have oversight of the clinical development and drive execution of the development plan. In addition, you will enable an empowered organisation, which can navigate in a matrix environment and adjust quickly to business needs.
Entrepreneurial; excited by new challenges and not intimidated, but instead invigorated by the ambiguity and risks associated with an 'early-stage' endeavour.
A predisposition to roll-up-the-sleeves and personally engage in the work at hand; comfortable working in the resource-constrained, fast-paced environment of early-stage companies.
- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
- Leading development of clinical sections of trial and program level regulatory documents
- Driving execution of the clinical program and/or trial in partnership with global line functions, assigned Global Trial Directors and regional/country medical associates, where applicable
- Provide medical input into Clinical Development Plan Integrated Development Plan and Clinical Trial Protocol reviews and contributing to/driving development of disease clinical standards for new disease areas
- As a medical expert, supporting the Sr GPCH or CDH in interactions with external and internal stakeholders and decision boards
- MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (or equivalent)
- Minimum requirement of years of experience in clinical research or drug development will be commensurate with level.
- Experience in an academic or industry environment spanning clinical activities in Phases I through IV required.
- 2 years (or equivalent) of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
- Working knowledge of one of the above listed disease areas is desirable, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s)
- Demonstrated ability to establish effective scientific partnerships with key stakeholders
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Previous global people management experience is preferred, though this may include management in a matrix environment.