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Senior Clinical Scientist
- We are looking for a Senior Clinical Scientist
- Pharmaceutical company
About Our Client
Our client is a growing pharmaceutical company.
Our client is looking for a multipurpose candidate for its Medical Affairs department, dealing with Clinical Development, Business Development and Regulatory affairs tasks.
The opportunity involves the following tasks:
- Evaluation of clinical and nonclinical proposals for studies.
- Protocol design and trial management Phase I-IV based on strategic needs of company on global basis. Successful management of investigator initiated trials, grant reviews, non-trial activities and publications.
- Prepare and review project and study documents including clinical trial protocols, clinical study reports, Investigator Brochure.
- Perform literature search and data analysis to address research questions.
- Assisting in database cleaning, review of study results, and interpretation of results.
- Keep current with developments in therapeutic areas of interest and relevant regulatory and scientific developments.
- Participate in advisory board meetings as required.
- Conduct scientific due diligence on partnering opportunities.
- Prepare and review regulatory submissions including briefing books and presentations for meetings with regulatory agencies and marketing authorization.
- Participate in meetings with regulatory agencies as scientific/clinical expert.
- Partner with patient advocacy groups as needed.
- Master the relevant literature on products and related diseases.
- Support the scientific development, the regulatory and reimbursement efforts to prepare access into health systems.
The Successful Applicant
- PhD required.
- 5/6 years of experience as clinical research and medical affairs in the pharmaceutical industry.
- Strong understanding of clinical research methodology (Study design, protocol writing, CRF preparation, knowledge of GCP and regulatory requirements).
- Deep knowledge of the IND/NDA/CTD/MAA process.
- Excellent technical writing skills with experience of writing nonclinical and clinical summaries and clinical trial forms.
- Experience in medical and scientific and clinical research techniques in anti-infective therapeutic area.
- Excellent organizational skills.
- Team oriented with strong collaboration with different department of the company.
- Excellent communication skills.
- Willing to travel 10/20%.
- Fluent in English, French and German would be a plus.
What's on Offer
Join a growing company in a challenging position.