Head of Clinical Development, Recordati Rare
vor 4 Wochen
The purpose of the role is to lead the Clinical Development Team and work with all centrally managed groups, including Clinical Operations, Regulatory, Safety, Preclinical and CMC teams, to efficiently develop new drugs and manage Life Cycle programs of marketed drugs, in line with the agreed strategy for the Rare Diseases business and in compliance with all applicable laws/regulations, internal procedures and Group standards.
- DUTIES AND RESPONSIBILITIES
- Define the clinical development plan for new drugs and/or new indications for marketed drugs, in line with the agreed strategy.
- Ensure the preparation of high quality study protocols, with suitable objectives and end-points to meet the agreed Target Product Profile and achieve timely regulatory approval.
- Lead the creation of clinical components of key documents (e.g. Clinical Trial Protocols-CTPs; Investigator's Brochures; Clinical Study Reports-CSRs; regulatory documents including maintenance of product licenses, registration dossiers, value dossiers and pharmaeconomic dossiers)
- In cooperation with the Clinical Operations Group, supervise clinical trials conduct by providing senior medical expertise and maintaining frequent contacts with key investigators and support management of CROs and others vendors for optimum resource utilisation
- Ensure appropriate medical management of any safety issues
- Drive the creation and review of Integrated summaries of efficacy (ISE) and safety (ISS) for regulatory submissions/approvals
- Ensure timely preparation of clinical study reports according to company policy and international rules
- Accountable to efficiently manage budgets and resources
- Track appropriate performance measures and management of deviations and risks across the study program
- Plan and execute publication and clinical communication strategy in coordination with Medical Affairs, and provides input to key external presentations
- Ensure timely exchange of information on planned and ongoing clinical trials with Group Medical Director/HQ, as per corporate SOP
- Build and develop relationships with Health authorities, expert advisors and key investigators / opinion leaders
- Provide senior medical expertise during the assessment of new in-licencing opportunities
- In cooperation with Medical Affairs and other functions, identify new possible development opportunities for marketing products
- Implement innovative approaches to clinical development and life cycles programs, including data mining, RWE, historical data, and alternative strategies.
**EDUCATION & EXPERIENCE**
Medical degree, PharmD or PhD with strong scientific background
Solid experience (minimum 15 years) in Clinical Development
Experience in multiple therapeutic areas including Oncology
Knowledge in the rare diseases field or in niche market products
Experience in management of multi-cultural projects/studies
Knowledge of clinical program requirements
Experience in conducting clinical trials from design to reporting
Experience in regulatory submissions, reviews and approvals
**SKILLS**
Ability to coach, motivate and guide people in matrix structures
Excellent communication skills
Fluent in English
Open to new methods, ideas or approaches
Capacity to manage multiple projects
Business Acumen
Considerable organisation awareness including experience working cross-functionally and in global teams
Excellence in team working and building relationships across internal and external stakeholders, both in Europe and across global landscape
Have exhibited strong leadership
Flexible and adaptable
Positive thinking and enthusiasm
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