Company Overview
30 Technology is a privately owned biopharmaceutical company developing nitric oxide-generating technologies for healthcare applications. We have the most impactful antimicrobial platform that has been developed in the last 50 years. Convatec purchased our woundcare arm in early 2023, and we now focus on treating respiratory infections and developing new formulations for other areas. Our products are undergoing multiple clinical trials against a variety of diseases.
Job Description
The Clinical Development Lead (CDL) will work closely with Head of Clinical Program Management (HCPM) and lead the generation of clinical development plans/timelines for all 30 Tech assets across respiratory and other therapy areas. The CDL will be responsible for researching new disease indications and collaborating with key opinion leaders to solidify plans.
The CDL will support HCPM and Quality consultant to develop robust systems and operating procedures to enable continued success and inspection readiness.
The CDL may also be required to lead clinical programs and plan, implement, monitor and review studies in line with the business and clinical development plans, whilst meeting all ethical, regulatory and scientific needs. They will also be charged with ensuring the quality and integrity of data, compliance with relevant business processes and regulatory requirements and study completion on time and within budget.
Key Responsibilities
- Develop clinical development plans for all respiratory assets
- Research future indications and perform KOL mapping
- Lead scientific advisory boards to gather information and strengthen clinical development plans
- Develop synopses and lead CRO selection processes
- Build and maintain relationships with key external partners (sites, KOLs, vendors, etc)
- Line management and mentoring of junior staff (where applicable)
- Process development and systems integration
Knowledge, Experience and Skills
- Lifesciences, health sciences or related field, BSc equivalent or higher degree
- Fluency in English, including both oral and written communications. Proficiency in another European language is advantageous
- Strong track record of successfully executing clinical trials in the pharmaceutical/medical device industry (Phase 1-2a desirable)
- Finance and clinical trial budgeting experience
- Experience in developing RFPs, selection and management of CROs and vendors
- Ability to write study ICFs, protocols, study reports, sections of investigator brochures and regulatory documents with minimal supervision
- Excellent interpersonal skills and demonstrated ability to lead
- Extensive knowledge of ICH GCP, FDA and EMEA regulations and guidelines
- Functional expertise to initiate, author, or contribute to SOP development and process improvement initiatives, implementation and training
- Respiratory or anti-infective TA experience a plus, as is experience with drug device combination studies
- Experience developing site engagement and recruitment strategy plans
- Solid mentoring/line management experience as well as cross-functional leadership
Key Personal Attributes
- Highly motivated with a results and timeline focus
- Team player
- Able to take direct responsibility for program execution and outputs
- Able to perform in a fast-paced environment and proactive in identifying and resolving challenges
- Has experience with line management (depending on level) and cross functional team leadership
- Comfortable with “rolling their sleeves up” to address challenges
Location
- Head office, Oxford Street, London
- Minimum 2 days in office per week preferred
- Up to 20% of time spent travelling meeting the team, study sites etc.
We offer an attractive compensation package, including a competitive salary, performance related bonuses and the opportunity to join our long-term incentive plan. We also offer our employees a range of additional benefits including private healthcare, life assurance cover, car leasing scheme, cycle to work and other wellbeing initiatives.
Application details
To be considered for this opportunity, please submit your CV and a cover letter to careers@30.technology