VP, Clinical Development, IO

Biocompatibles UK Limited (Biocompatibles UK) is a growing international specialist healthcare company. Its mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. Biocompatibles UK wishes to hire a VP, Clinical Development, IO who will be responsible for the strategy, planning, design, resourcing, management and oversight of the clinical development of Biocompatibles UK’s Interventional Oncology project pipeline. These efforts will be conducted with GCP compliance and in keeping with regulatory requirements and industry best practice.

The main duties and responsibilities of the position include:

• providing strategic clinical operations direction to clinical project team members;
• participating in meetings related to strategy of program, indication and studies;
• reviewing and approving protocols, ICFs, and study related plans and being responsible for incorporating the operational delivery aspects and logistics into the protocol;
• being responsible for selection of CROs (and other vendors) and creation and negotiation of contracts and/or work orders and performance;
• collaborating with Manufacturing/Supply chain to ensure the availability of clinical trial supplies across the program;
• attending investigator meetings, kick-off meetings, monitoring training and various CRO (or other vendor) meetings;
• being responsible for overall clinical program timeline deliverables and ensuring that the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Business Unit;
• participating in negotiation of budgets with vendors, reviewing and overseeing budgets, forecasts and accruals for clinical studies;
• ensuring clinical projects remain on schedule and within approved operating budget;
• ensuring mitigation and contingency measures are prepared and implemented, actively assessing potential risks to the study/program and proposing mitigation plans;
• assessing long-range resource needs and making recommendations and allocations across projects;
• developing and reviewing strategy for operational efficiency, collaborating on SOP development and promoting standardised use of Clinical business tools;
• assisting in the development of short and long term objectives for clinical programs;
• reporting timeline risks and providing mitigation strategies to the SVP, Head Clinical Development;
• participating in the design and development of clinical trial protocols;
• providing oversight for development of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials;
• approving the study implementation plans (internal and/or CRO), studying oversight plans and managing relationship with CROs and other vendors;
• managing relationships with Academic Research Organisation (ARO);
• managing investigational product supply forecasting at program level;
• liaising with Regulatory regarding health authority submissions and overseeing and assisting with the development of the clinical components of regulatory submissions including but not limited to safety, interim and final study reports;
• being responsible for Steering Committee and/or DSMB planning and execution which may entail working with the Medical Lead to create the DSMB Charter, taking accountability for DSMB (or adjudication committee) meeting management and taking responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards;
• supervising functional and/or direct reports and in addition to providing instruction, direction of daily activities in support of goals, conducting a performance evaluation against development goals and career path requirements for direct reports as well as coaching and guiding functional and/or direct reports in support of development needs and facilitating conflict resolution;
• designing, updating and implementing appropriate innovative and best-in-class procedures and SOP’s related to clinical study development and execution in collaboration with Quality Assurance;
• collaborating with Quality Assurance, QC function and regulatory Operations to implement TMF quality standards; and
• being responsible for implementation of CAPA in relation to sponsor’s audit or regulatory inspection or any study irregularity.

As VP, Clinical Development, IO, you must have/be:

Essential

• a Bachelor’s degree in a scientific discipline;
• experience of clinical development and organisational management within the pharmaceutical industry, such as a CRO or a similar organisation;
• previous line management or direct management of team members;
• understanding of GCP and ICH Guidance;
• writing communication and presentation skills;
• excellent management and leadership skills;
• desire to contribute to growth of team and company, entrepreneurship and resourceful;
• highest standards in terms of compliance;
• strategic mind set; and  
• detail oriented.

Desirable

• an advanced scientific degree;
• global experience with demonstrable knowledge of clinical development and strategy; and
• knowledge of current US FDA regulations and other relevant global regulatory requirements.

Applications to be sent to: HR@btgplc.com.

Closing date for applications is 2 January 2017.