Head of Clinical Development - Immunology
An international medical devices company is advertising a vacancy for a Global Training Education Manager, to be based in the company's European office. This organisation works across all modalities for ventilated and non-ventilated patients, significantly improving aerosol drug delivery. This is an exciting opportunity to work with an establishment that focuses on getting better patient care across hospitals.
- Co-responsibility for the design of an effective (global) clinical program strategy for all AT clinical programs. This responsibility will be shared with the Clinical Director and the Medical Project Leads.
- Accountable for costs, quality and keeping timelines of assigned projects as Strategic Sponsor [PK2] , including business case development, escalation and effective communication to executive management and updates during Executive Project Meetings.
- Accountable for provision of clinical strategy input to Project Management, QA, customers in Supply Operations, Distribution and Quality and Regulatory Affairs in providing timely information on trial scope, material requirements and investigations relating to maintaining GCP.
- Co-responsibility that clinical trials meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products. This responsibility will be shared with the Medical and Operational Project Leads and Study Leads.
- Co-responsibility for efficient operational aspects of clinical studies, working closely with the Head of Clinical Operations, the Operational program leads, and Study leads for assigned projects as Strategic Sponsor.
- Accountable for the development of innovative and benchmarked processes to match evolving new demands of the clinical development, including Clinical IT infrastructure.
- Accountable for the pre-clinical study programs, quality, costs and timelines.
- Accountable for identifying pre-clinical and/or clinical IP opportunities, including IP submission and maintenance, where applicable.
- Accountable for a IMP and non-IMP supplies for clinical trials including an effective forecasting strategy in cooperation with QA.
- Accountable for an efficient R&D contracting process.
- Responsible for efficient dissemination of results at time of completion of clinical trials to key stakeholders, including Executive Management and ATL Board for assigned projects as Strategic Sponsor.
- Responsible for preparation of clinical trial abstracts, posters and presentations of key clinical findings to be presented at allergy conferences.
- Establish, maintain and manage global networks of allergy experts and collaborators in the clinical research program.
- Represent the Company as needed as a senior medical spokesperson to a variety of scientific, business and government groups/agencies.
- Co-responsibility for CRO and vendor selection to ensure that they fulfil required high quality standards. This responsibility will be shared with the Operational Program leads and QA.
- Work with the Clinical Quality Manager to ensure efficient induction of new members of the clinical department, an efficient SOP system, common document archiving and global training programmes.
- Provide line management, direction, motivation, and career development for the clinical development team, identify and further develop Subject Matter Expertise area's, making effective use of expertise the combination of all individual's experience and knowledge whilst also being respectful of the budget.
- Develop Data Management role(s), statistical programmer, clinical IT support roles and Clinical PV role as value added and cost effective functions within the Clinical Development group.
Skills and Requirements:
- Relevant PhD in life sciences.
- At least 8 years' experience in in leading a clinical development and or /clinical operations programme within Biotech or Pharma.
- At least 5 years' experience in defining clinical trial strategy.
- Proven line management experience.
- Experience as clinical study manager.
- Experience of successfully running multiple clinical studies simultaneously.
- Knowledge and understanding of best practice in clinical trial conduct and GCP.
- Respiratory and/or allergy and/or related program experience.
- Experience in completion of studies underpinning successful MAA.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Russell at +44 203 824 6104 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.