Associate Director/director of Clinical

vor 3 Wochen

Ulm, Deutschland Recordati Group Vollzeit

**The role can be based at Recordati's European offices in France (Paris or Lyon), UK (Hemel Hempstead), Italy (Milan), Spain (Madrid) or Germany (Ulm) and will involve international travel. We offer hybrid working with a minimum of 2 days per week in the office.**

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

**Job purpose**

The Associate Director/Director of Clinical Development will sit within Recordati's recently restructured R&D organisation, and be an integral part of a team whose mission is to further strengthen the capabilities of R&D here at Recordati.

The role will participate in the preparation of the oncology portfolio clinical development plans, based on the strategy agreed with the cross-functional team, and lead several key projects. The AD/Director of Clinical Development will establish and maintain excellent partnerships with the medical/scientific community and key opinion leaders (KOLs), as well as with patient's associations and provide medical/clinical support to the clinical operation team for the setup, conduct and finalisation of planned and ongoing trials/clinical development plans. The role will act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.

**Main responsibilities**

Maintain engagement across the global landscape with all potential investigators to identify appropriate clinical trial programs and supervise investigator-initiated trials to data portfolio.
- Lead the preparation and the execution of clinical development plans and of the study protocols, in line with company strategies and objectives.
- Act as primary contact for any study related medical/clinical questions and manage the preparation of responses to clinical related FDA, EMA and other regulatory authorities' requests.
- Prepare and/or supervise the preparation of all clinical documents necessary to study setup, in accordance to current regulations and laws.
- Review and recommend amendments to the study protocols, investigator brochure and Informed Consent Forms to ensure study feasibility.
- Ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the regulatory and pharmacovigilance departments.

**Clinical Trial Operations**
- Maintain close relationship/provide clinical and medical support to clinical operations team to ensure smooth and effective study setup and management.
- Participate in internal and external clinical meetings, including committees to assess/approve support to investigator-initiated trials, investigators meetings and Advisory Boards, related to assigned clinical studies.
- Support to clinical operations to identify high quality investigators and study sites for the conduct of clinical studies.
- In cooperation with the safety leads, ensure that any important safety issues are discussed and handled with appropriate departments.
- Work closely with statistics/DM team to ensure data analysis and interpretation of data.
- Prepare and finalise clinical study reports.
- Prepare the study related communication plans and publications

**KOL Management**
- Establish and maintain excellent professional relationships between the company and Key Opinion Leaders (KOL) and the broader medico
- scientific community.
**Competencies required**
- Analytical thinking and dealing with ambiguity in a fast-moving environment
- Planning, organising and flexibility
- Excellent communication and collaboration skills, including delivering presentations to remote and live audiences
- Business agility

Technical & professional expertise required
- Qualified physician - board certification preferred
- Minimum 5 years' experience in a clinical and/or medical affairs regional/multi-country role at a similar level
- Rare disease/oncology experience is preferred
- Track record of successfully working within and coordinating cross functional team

**Personal specification**
- Fluency in written and spoken E

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