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Reporting to the General Manager and working under the supervision of the Group VP Development, the R&D Manager manages R&D projects within a time frame and a given budget. He provides strong input in the group regulatory strategy and expertise on all aspects of clinical operations.
The R&D Manager conducts the pharmaceutical and clinical development of projects under his/her responsibility, in close collaboration with R&D dedicated team members and/or Affiliates employees involved in R&D. He provides guidance and support to the group regulatory strategy. He will design and construct the clinical development plan in compliance with regulatory guidelines and requirements. He is in charge of the design, the development and the implementation of the clinical studies and contributes to the building of the submission dossier.
Management of R&D projects in close collaboration with R&D team:
- In collaboration with the Pharmaceutical Development Manager, contribute to the development and implementation of the pharmaceutical plan of R&D projects under her/his responsibilities.
- Design the clinical development plan of all R&D projects of the group in accordance with current regulatory guidelines.
- Manage the budget of R&D projects under her/his responsibilities
- Manage project schedules and milestone.
Provide strategic regulatory guidance to the R&D team:
- Develop and implement regulatory strategy for the product development and commercialization.
- Guide regulatory strategy for all development projects, anticipating changes in regulatory environment and approval requirements (in view of product registration).
- Provide clinical / regulatory leadership in the design and construct of the R&D plan to ensure product registration.
- Provide support to the Regulatory Manager.
- Organize, conduct and/or participate to meeting (scientific advise) with health authorities.
- Write clinical section of submission dossier.
- Response to health authorities clinical questions and comments during registration process.
Design clinical plan:
- In compliance with regulatory guidelines and requirements.
- Planning and identifying resources for clinical studies based on project timelines.
- Taking into account manufacturing and formulation plan.
- Detailing timelines, cost, milestones and regulatory filing strategy.
- To meet company needs (comparator, cost, timing etc).
Design and conduct clinical studies:
- In accordance with regulatory guidelines.
- Identify emerging trend/regulations in clinical research while proactively integrating these elements into policies and procedures.
- Select, hire and supervise CROs.
- Negotiate and Establish (with the legal department) contracts with CROs including scope of work and clinical trial specifications.
- Ensure that the study is conducted under Good Clinical Practices.
- Write/review clinical protocols, CRFs, study reports, inform consent.
- Analyze clinical data.
- Ensure archives of studies' documentation.
Meeting and reports:
- Report to the General Manager of the Spanish Affiliate and under the supervision of the group VP Development.
- Participate to monthly R&D meeting.
- Provide weekly update on the status of the projects/clinical studies.
Budget:
- For projects under his/her responsibilities, identify resources requirements and elaborate a budget plan including the pharmaceutical development budget (in collaboration with the Pharmaceutical Manager)
- Elaborate clinical development plan budget including timelines and milestones.
- Respect allocated budget.
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| Requisitos: |
Degree in Medicine or Life Science. Postgraduate or Master of Science in Clinical Research and Regulatory Administration will be considered a plus.
Experience:
- The candidate will have a minimum of 7 years of experience in clinical research and regulatory affairs in pharmaceutical industry.
- Strong knowledge of regulations, guidelines and European registration processes.
- Experience in pharmacology, medical device, food complement desirable to provide input to the disease area strategy.
- Strong knowledge of Good Clinical Practices and international clinical regulatory requirements.
- Knowledge of the drug development process.
Excellent English and Spanish skills, both oral and written, are required.
French will be considered a Plus.
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