Intuitive Surgical Careers
Clinical Affairs Manager
Primary Location: United Kingdom-Greater London
Requisition ID: 180787
Position’s Objective & Summary:
The purpose of this job function is to serve as a Clinical Affairs Manager to support the overall clinical affairs strategy in Europe but with specific attention in UK & Ireland. To oversee initiation, progress and conduct of European clinical studies, physician initiated research activities and publication efforts. The candidate will ensure compliance with the law, Good Clinical Practices (GCP), ISO14155, Intuitive Surgical SOPs, and any other applicable regulations.
This position is based in the UK with direct reporting to Clinical Affairs, Europe Intuitive Surgical Headquarters, in Switzerland.
Roles & Responsibilities:
This position has
responsibility and authority for:
- Development of clinical evidence strategy to address regulatory and reimbursement gaps, or otherwise for the medical community as required
- Develop strong relationships for Intuitive Surgical with leading KOLs and with internal colleagues
- Consult with leading KOLs, individually or via advisory panels to develop specific clinical programs
- Actively represent clinical affairs in the UK & Ireland; internally and externally for reimbursement or other government agency meetings or conferences as required
- Intuitive Surgical Sponsored Studies
- Manage and execute clinical research activities essential to the successful management of pre and post –market clinical studies in UK & Ireland (phase III-IV).
- Accountable for clinical project management of Intuitive Surgical sponsored studies; from protocol development to final reports and publication (i.e. including study documentation, site selection, enrollment, follow-up, monitoring, data analyses and reporting)
- Ensure audit readiness of clinical activities for relevant regulatory standards
- Management of Contract Research Organization (CRO) or independent clinical service providers, e.g. identification of suitable partner(s), development of contracts or work charter and interactive management of entity to ensure project success
- Develop reports for submission to regulatory agencies and internal/external publications
- Investigator Initiated Trials (IITs)
- Develop strong partnerships with surgeons and other external parties that conduct large investment clinical evidence projects that Intuitive Surgical fund, to ensure that the project(s) meet the evidence requirements and are conducted to appropriate legal and regulatory requirements and keep within budget
- Review physician initiated projects or research; determine suitability of protocols, proposed, ability of center to conduct the trial within the expected timeframe and resource request (including budget), and ensure achievement of project milestone per payment
- Generate clear and concise trip reports, site contact documentation, monthly status reports for projects
- General participation of meetings, reporting and adherence with Intuitive Surgical policies
Required Knowledge, Skills, and Experience:
- Graduate qualification in Life Sciences, medicine or medical sciences, with a preference for PhD.
- Experience working in the medical device industry in clinical affairs/medical affairs/research function, with evidence of full project management responsibility, for at least 6-10 years. Surgical or interventional medical device experience, phase III to IV is preferred.
- Preferred knowledge of the UK & Ireland reimbursement process and research framework for conduct of clinical studies for this purpose. Experience of developing and preparing evidence for local agencies, e.g. NICE or CRGs desirable.
- Excellent communication and interpersonal skills with strong influencing abilities.
- Experience of managing physician initiated projects preferred and CRO’s or external consultants required.
- English language required other European languages an advantage.
- Experience of publishing clinical research (own or in clinical industry capacity).
- Strong numerical and literary analytic skills - ability to assess data and literature quickly.
- Comfortable in a hospital/surgical environment.
- Must be able to travel about 50% (mostly in the UK & Ireland).