Head of Global Clinical Operations, Endocrinology
vor 19 Stunden
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
**Job purpose**
The Head of Global Clinical Operations, Endocrinology will work cross-functionally, leading planning and management of clinical trials in endocrinology from an end-to-end trial management perspective to achieve Recordati Group and Recordati Rare Diseases objectives. The role will have oversight of budget and resource allocation within assigned trials, drive operational excellence through process improvement and knowledge sharing across clinical trial program and be the point of escalation for resolution of trial management issues within the assigned trial program.
The role will work closely with all Clinical Operations functions within our Corporate headquarters in Milan and in key regions including the US. Key stakeholder relationships will be in place with all internal line functions and vendor staff involved in clinical trial conduct together with medical and scientific staff working in the relevant therapeutical area.
**Key responsibilities**:
- Leads and oversees the cross-functional project team assigned to conducting clinical trials
- 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 the Clinical Study Manager in leading the development of clinical trial protocols and trial related documents
- Leads or supports the Clinical Study Manager in leading the operational management of clinical trials to ensure deliverables are met within established timelines, budget and quality/compliance standards
- Ensures ongoing scientific review, final analysis and interpretation including the development of clinical study reports (CSRs), reviews and contributes to publications and internal/external presentations related to clinical trials
- Acts as the main line of communication to relevant internal stakeholders and ensures progress reporting (clinical trial status, resources, budget and timelines)
- Responsible for the management of the Endo Clinical Trial budgets, challenging the CROs on timelines and cost control
- Leads development or supports the Clinical Study Manager in leading the development of clinical outsourcing specifications to facilitate bidding process and selection of vendors; manages interface with vendors in cooperation with line functions; ensures vendors meet quality standards; contributes to the development/amendment of vendor contracts
- Manages the Global Endocrinology Managed Access Programs
- Authors/reviews relevant SOPs in collaboration with Quality Assurance
**Specific competencies and skills required**
- Minimum of 8 years leadership experience in global clinical research, with focus on clinical trial design and development.
- Degree in medicine, health care, life sciences or related field
- Experience with coordinating Clinical Study Managers / Clinical Research Associates/Monitors
- Strong experience in managing complex budgets, negotiating with CROs, and challenging them on timelines and cost control
- Extensive knowledge of clinical development process, GCP/applicable legislation, and clinical project management
- Experience in international clinical trials and working in a matrix environment
- Ideally experience in large and medium size pharma companies
- Knowledge of endocrinology or in the rare disease field would be a plus
“_At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of
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