Job Title – Associate Director of Clinical Operations
Location – Oxford UK, with international travel
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone therapy for aggressive diseases, including immune-evasive, therapy resistant cancers, fibrosis and viral infection. The Company has offices and laboratories in Bergen, Norway and its clinical development team is based in Oxford UK.
We are looking for an enthusiastic individual to join our growing team. This full-time permanent position is well suited to an individual who has a can-do attitude, is a self-starter and takes initiative. Based within the Clinical Operations team you will be responsible for the execution of clinical development of the company’s assets in assigned portfolio. Your role will be to deliver clinical proof of concept and create a package ready for licensing or to move into phase Ill. To achieve this, you will need to be a strong leader with a capacity for multitasking and have strong interpersonal skills.
Key responsibilities include:
- Execution and delivery of the clinical trials supporting the clinical development plan of assigned portfolio within agreed time, quality and budgetary parameters.
- Contributing to strategy discussions for proposed clinical trials within assigned portfolio.
- Input and reviewing key study documents including protocols, ICF, IMPD, DSUR & IBs and ensuring that they are approved in accordance with internal procedures.
- Ensuring trials within assigned portfolio are delivered in compliance with Company and applicable Vendor SOPs, relevant national legislation, international and GxP guidance.
- Providing clinical operations expertise into projects within assigned portfolio (e.g. country selection, feasibility, operational input into design, external partner management) to support governance interactions and study start-up.
- Leading the process to identify and resolve operational issues and drive delivery through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations).
- Oversees Ethics Submissions and communications for trials within assigned portfolio.
- Ensures details of clinical trials within assigned portfolio are accurately recorded in external registries and that company confidential information is protected (applying for deferrals or arranging redactions as appropriate) in line with business priorities.
- Proactively maintains therapeutic area knowledge.
- Participates in impact assessment of new regulations, GxP and other relevant guidance.
- Provides reports and presents to senior management as required.
- Provides training, mentoring and support to the Clinical Operations team and other departments as required
You will ideally have had experience of working in CROS and world-class biopharma or large pharmaceutical businesses, combined with exposure to similar companies, with an understanding of the challenges facing an innovative company going through rapid growth.
You will also have proven ability of managing budgets, hold a biomedical science degree (or other appropriate proven qualification/education/experience) and be fluent in written and spoken English. Significant knowledge of project management techniques as well as an ability to work collaboratively within an international matrix organisation will ensure your success. You will thrive in a fast-paced, multi-disciplinary and changeable environment, making positive use of the opportunities it presents by being creative and dynamic.
We offer a competitive salary, excellent pension and benefits package, flexible working hours and opportunities for development within the role and progression of your career. We have a strong, loyal and inclusive company culture, in a recent Employee Survey results show that BerGenBio employees appreciate their colleagues, working environment and want to continue being a part of the team.
We are an equal opportunities employer and ensure that all applications are treated appropriately and fairly and that, all things being equal, no candidate is rejected because of their age, gender, race, sexuality or any other protected characteristic.
To apply please send your CV and a covering letter, including your current salary and package details, to email@example.com. Closing Date for applications is Friday 11th June 2021. To apply you must have eligibility to work in the UK and not require sponsorship. No agencies please.