CLINICAL RESEARCH MANAGER / ASSOCIATE DIRECTOR

Sep 18, 2019

OXFORD | FULL TIME

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.

THE ROLE

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.

THE INDIVIDUAL

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.

KEY RESPONSIBILITIES

  • 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


E
SSENTIAL REQUIREMENTS

  • 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

 
IDEAL REQUIREMENTS

  • 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.

APPLICATION DETAILS

To be considered for this exciting opportunity, please submit your CV and a cover letter to  john.efthimiou@30.technology

Closing date: 31st October 2019

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.

30 TECHNOLOGY is developing and defining new models of care to treat many serious medical conditions by enhancing the body’s healing and defence mechanisms.

30 TECHNOLOGY Therapeutic Nitric Oxide