Clinical Research Medical Director
Miejsce pracy: dolnośląskie, mazowieckie (Wrocław lub Warszawa)pełny etat
- Responsibility for all medical affairs functions, providing medical oversight and decision making for all critical issues.
- Overseeing the writing of all critical program documents pertaining to the asset’s development, including but not restricted to study protocols, the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports.
- Subject safety consulting for sites on inclusion/exclusion, study drug, AE/SAE, etc.
- Collaboration with other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs).
- Providing therapeutic and protocol-specific training to the project teams.
- Providing strategic guidance through participation in key associations (medical, clinical, industry) to influence policy and regulations.
- Discussing with clients, investigators and healthcare professionals all medical issues in the pre and post approval services, by using proper medical judgment, interpretation and decision.
- Providing medical consultation to team members and answer study related medical questions.
- Analysis and assessment of safety data to identify and manage emerging safety signals.
- Medical reviewing of individual case safety reports, serious adverse event reports and clinical outcome reports.
- Providing Medical Expertise to discussions with internal and external stakeholders.
- Presenting WPD Pharmaceuticals` standard medical safety processes to clients at business development meetings and communicate with various medical communities to explore and expand WPD business.
- Writing, reviewing and approving reports, regulatory submissions and protocols, ensuring that the medical content is accurate and complete.
- MD, MB/BS or equivalent degree and strong medical knowledge, proven clinical experience.
- Experience in a pharmaceutical/medical practice and fully trained in all aspects of drug development including clinical research, GCP, local regulatory requirements and data privacy laws.
- Ability to lead a study from the medical perspective.
- Excellent interpersonal, communication, and presentation skills.
- Ability to organize, prioritize and work effectively in a constantly changing environment.
- Fluency in spoken and written English.
- Participation in research projects concerning innovative anti-cancer drug development including pre-clinical and clinical stages, in Warszawa or Wrocław.
- Work in a dynamic, interdisciplinary team.
- Cooperation with renowned academic and business institutions in Poland and worldwide.
- Opportunity for professional growth and qualification improvement.
If you are interested, please send your CV via "Aplikuj na stanowisko" button below.
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Aplikuj do: 2020-02-29