Clinical Operations Lead Uk

7 months ago

London, United Kingdom Recordati Group Full time

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.

**_“Do you want to join a clinical development team whose goal is trying to find solutions for diseases with a significant unmet medical need. We are currently involved in several game-changing projects and need to increase our team. The team and projects are growing and there are important development possibilities”_**

**Role Purpose**
- The Clinical Operations Lead (COL), is responsible for building, leading and managing all clinical operations aspects of the program/project in order to maximize its future clinical and commercial success._
- The Clinical Operations Lead (COL) supports the global drug development activities and ensure the clinical trial(s) management of Rare Diseases branch (Company sponsored or ISS) as well as if applicable any clinical trial activities related to post marketing regulatory commitment._
- The Clinical Operations Lead (COL) is responsible for working collaboratively and cross-functionally with Clinical Development, Project Management, Regulatory, Medical Affairs, CMC, Quality Assurance, Drug Safety, Distribution & Supply, Manufacturing, Commercial Development, Finance and Academia to optimize the overall Project opportunity for Recordati, from CTA/IND to Clinical POC._

**This new position can be based from Hemel Hempstead (London) or Paris or Milan or Madrid or Lyon**

**Key Responsibilities**:

- Guiding all activities related to the clinical development of the product, involving all functions at appropriate time. 360-degree knowledge of development requirements and strategy to bring the product through to market.
- Manages all aspects of Investigator Sponsored Studies involved in the strategic development of RRD.
- Building, leading, and managing all clinical development aspects of the program/project to maximize its future clinical and commercial success from CTA/IND to NDA/MAA
- Helps in the realization of the clinical development programs and is responsible for the delivery of one or more clinical studies, including post marketing studies from the study concept through submission.
- Together with the Clinical Study Manager manages study deliverables in alignment with the study timelines and quality goal through internal and external resources
- Working collaboratively and cross-functionally with R&D, Clinical Development, Regulatory, Medical Affairs, Manufacturing, Quality Assurance, Drug Safety, Project Management, Distribution & Supply, Commercial Development, Purchasing, Finance and Legal.
- In collaboration with the Clinical Study Manager and the Clinical Trial Team manages the planning, conduct and closure of the clinical trials, in accordance with the applicable legislation and SOPs. Leads or supports CSM in the development of clinical trial protocols and trial related documents
- Identify other product or service opportunities to enhance impact that Recordati can have on a disease to help patients and their families.
- Responsible for the management of the Onco Clinical Trial budgets, challenging the CROs on timelines and cost control
- Engage all levels of management across Recordati to resolve resource conflicts, remove obstacles, and implement risk mitigations.
- Selects and manages vendors (eg, CROs, agencies) in accordance with SOP
- Plans and manages budget and forecast for the assigned clinical trials / projects

**Technical / Professional Expertise**
- Proficient understanding of R&D drug development processes (both pre-clinical and clinical) and biopharmaceutical industry
- Experience in international clinical trials and working in a matrix environment
- Life Sciences higher educational level or other relevant qualification
- Team leadership, integration, and conflict management skills. Can guide the team through multiple points of views.
- Ability to work independently, navigate ambiguity, adapt to change and make rapid, disciplined decisions to enable agile execution.
- Proven ability to network and collaborate across multiple teams with flexible, positive attitude

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