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Clinical Research Manager / Associate Director
Company: 30 Technology
The opportunity has arisen for a person to work in 30 Technology, a young biotech company, working closely with the Chief Medical Officer, to help to develop and operationalise the clinical development projects across the various company verticals in respiratory, infectious diseases and regenerative medicine/wound healing, supported by good preclinical and clinical data already achieved with the company’s primary nitrite/nitric oxide technology.
A Clinical Research professional is sought to run a series of strategically important clinical development programmes across all the areas of interest. The role will report to the Chief Medical Officer.
Fundamental to this role is experience in contributing to clinical development plans, clinical protocols and related clinical regulatory submissions, as well as in delivering clinical programmes and all aspects of clinical operations.
Experience with helping to select and manage CROs to conduct clinical trials is essential, as is comfort with working with investigators and their sites and a range of relevant KOLs.
Understanding and wide experience of GCP and clinical quality requirements is also important for this role.
The new hire should have a pragmatic mind set, capable of being entrepreneurial. This is an opportunity to be part of a very exciting team at an early stage of its journey.
They should be comfortable working in a start-up environment without the large scale infrastructure and associated costs of a larger business. Energy and open-mindedness are critical traits.
Going forward, there are plans for further expansion, and so the successful candidate will possess not only the core skills to ensure success in the immediate challenge, but also the flexibility and head room to grow with the business as it progresses to the next stage.
The role will initially have no direct reports but this is likely to change as the company moves into its first clinical trials in the next 12 months or so.
Location & Remuneration
The position will be based most of the time at the new R&D Office near Oxford (Milton Park), with possibly weekly visits to the 30 Technology London office.
Occasional flexible home working (up to 1 day per week) may be possible after reaching the probation period of 3-6 months.
The company offers a package commensurate with the role. Given the potential for long term growth of the business, this is a role that offers significant upside potential.
This position would ideally suit an experienced Clinical professional with recent active clinical development and operations experience (>5years), looking to forward their career and progress clinical research in a number of novel areas. This is a great chance for a professional to join a progressive and developing company.
Experience and comfort in working in a small biotech environment is important. Excellent communication skills and an open and positive approach to working in project teams and in a relatively flat structure is important.
Helping to define and deliver key clinical research programmes and clinical studies
Selection, oversight and close working with CROs, clinical sites and investigators
Preparation of protocols, CTAs and clinical parts of regulatory and ethics submissions
Monitoring of clinical studies in line with GCP, and other relevant regulations.
Work with external strategic research partners and KOLs
Collaboration with medical professionals to run pre-clinical and clinical testing of prototypes
Life Science Degree
Experience with preparing clinical protocols, CTAs and clinical parts of regulatory and ethics submissions is important.
Experience with selecting, overseeing and working closely with CROs and clinical sites is important, as is experience in monitoring clinical studies.
Phase I and II early clinical development experience is essential.
Experience in respiratory and/or infectious disease clinical development and clinical trials.
In depth knowledge and experience of GCP/ICH guidelines.
Proven success in clinical trial management and delivery.
The individual should be comfortable as a player and manager and in working in flat, matrix, cross functional environment and in cross functional project teams.
Early and late phase clinical development and clinical operations experience ideally.
Clinical development and clinical operations in relevant therapy areas, including respiratory and infectious diseases would be an advantage.
Passion for the science and clinical application of the 30 Technology are also important.
Experience working in a start-up or small biotech environment, and ideally also in pharma would be ideal.
30 Technology was created as a group of seven wholly owned subsidiaries aligned to its research programs and market verticals:
30Respiratory, 30Woundcare, 30Therapeutics, 30Pharma, 30Dermatology, 30AnimalHealth and 30Innovation.
30 Technology aim to unlock and deliver the promise of therapeutic nitric oxide by developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.
Nitric oxide (NO) is a volatile gas, produced in tissues of the body, which acts as a vital cell-to-cell signalling mechanism. The discovery NO is involved in a number of critical physiological processes led to a 1998 Nobel Prize. Since then, a number of attempts have been made to harness its multiple therapeutic effects which include increased blood flow, regulation of immune response, abroad-spectrum anti-microbial activity and acceleration of healing.
However, NO has a very short half-life, so sustained release and practical delivery is difficult to attain. 30 Technology has solved these previously intractable problems, utilizing proprietary IP to create a platform technology which uniquely creates the opportunity to use NO in a variety of diseases and health conditions.
Additionally, our revolutionary 30Technology™ Intellectual Property allows us to deliver sustained NO into the lung via aerosol, through the skin via topical patches, gels, liquids and into the body for release from biomaterials in regenerative medicine.
Our technology is clinically proven and a potent solution to many serious medical conditions.
To achieve its goals, the 30 Technology has been highly successful in its first round of funding, raising more than £30m. The lead investor is Morningside Ventures, the Harvard, Boston-based Lifescience VC with an international reputation.
30 Technology is an equal opportunity employer. All applicants will be considered for employment without attention to race, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
To apply for this vacancy please get in touch with the recruiter using the details shown above.