Job title: Director, Clinical Development – Hybrid/ UK– Oncology/Rare Diseases
Company: Upsilon Global
Job description: Director, Clinical Development – Hybrid working – UK – Oncology/Rare Diseases
Upsilon Global are seeking a Director, Clinical Development to join a mid-sized French Biopharmaceutical who’s main areas of focus are oncology and rare diseases. With a commercial presence in 30+ countries, 4 x R&D hubs and 3 x development centres, this biopharma have built a solid reputation within the market.
Main duties of the role:
- To provide clinical and operational expertise and guidance for the design, implementation, resourcing and budgetary planning for clinical programs
- To work in conjunction with the therapy area experts in the creation and execution of deliverables
- To be the key point of contact for all Clinical Development related activities
- To lead the clinical development program(s), ensuring the full integration of study management within the GPT plans
- To ensure cross functional oversight of all study related activities
- To provide expert clinical support to Business Development as required during Due Diligence activities and ensure that Head of Clinical Programmes concurs with the assessment and recommendations suggested
- To support the Head of Clinical Programs for the planning, resourcing and management of clinical teams in collaboration with Clinical Team Leads To recruit, manage, mentor, train, review, develop and appraise all CPMs, CLs and CTAs in collaboration with the Head of Clinical Programs
- To analyse and recommend solutions to the Head of Clinical Programs and other Heads of Department within CDO and R&D on the organisation and participation in effective clinical trial programs
- To drive changes in processes for continuous improvement and adaptation to business model changes.
Responsibilities
- To take overall line management responsibility for development, support, review, training and appraisal of all direct reports
- To coordinate and manage all internal and external PM resources involved in the clinical programs
- To ensure that the timelines and all key requirements for clinical project plans are followed and appropriately shared with the Head of Clinical Programs to ensure alignment at all levels, in order to support the delivery of clinical development objectives
- To create initial budget proposals and updates with the support of the project financial controller and with all necessary HoF inputs, track, reconcile and manage the budgets associated with these Clinical programs, and secure approvals by the Head of Clinical Programs, Head of CDO, and AOLs as required for the project success.
- To ensure that the above information is timely and accurately forwarded to the Budget and Resources Team
- To take overall accountability for clinical studies within a Program in respect of: ensuring a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals through validation of key activities (study budget preparation, study timelines, country/site selection etc…)
- To ensure that cross-functional headcount is sufficient to allow appropriate conduct and delivery on time and quality of deliverables
- To provide expertise as required as a contributing author in the development of clinical documents (e.g. study concept, annual updates of the Investigator Brochures, IND, Briefing documents etc…), and to provide with the assigned dedicated CPM, an expert/functional review of study documents (e.g. Protocol, Reporting and Analysing Plan, Clinical Study Reports and other key documents) during the course of the clinical program
- To advise and participate in the SP selection in collaboration with the Procurement department and CTE function, providing support to Ipsen CPM for SP oversight and ensuring consistency within and across programs
- To participate and contribute along with Procurement department to SP oversight meetings
- To attend and contribute as required to advisory boards, expert scientific committees
- To contribute as clinical expert in the submission team as applicable
- To lead in fostering and developing a team approach to all activities associated with the implementation of clinical studies
- To complete all of the above activities within the framework and in compliance with Global SOPs, and other documentation in force within the Ipsen Group, ensuring timely reading and understanding of relevant SOPs
- To perform any other activity as may reasonably be required by Head of Clinical Programs from time to time
Required experience/background:
- M.D Degree 10+ years’ experience in clinical operations/clinical development
- Expertise in Clinical Development Strategy of Molecules, preferably in early-phase monoclonal antibodies clinical studies
- Experience in PK/PD studies, including biomarkers and pre-clinical studies
- Knowledge of publishing and clinical report writing
- Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting
- Experience in protocol writing and preparation of submission to regulatory authorities
- Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications)
- Experience presenting to board members and shareholders
- The applicant must be able to read, write and speak English
Expected salary:
Location: London – France
Job date: Thu, 16 Nov 2023 23:19:36 GMT
