Biotech Process Expert, Associate Principal Scientist
Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs. Plan and coordinate team meetings with CDMOs and follow-on with actions..
Apply expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results. Actively contributes to the development and implementation of strategy for Inhalation/Respiratory..
Conduct deal making activities to bring new products in to the company’s pipeline:
Assess strategic business fit and attractiveness of new licensing opportunities
Interact with Search & Evaluation and Market intelligence representatives to build a business case (product attributes, competitive edge, market potential, exit strategy, financial modelling) for new opportunities
Clinical Development Quality Lead
Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)…
Work closely with the Global Program Head(s) and Global Project Leaders (GPLs) to support/contribute to the development of the program strategy and its integrated development plan.
Guide innovation, provide drug development expertise and strategic leadership to the programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercial disciplines
Senior Clinical Scientist, Clinical Development
Drive development of protocols/protocol amendments for clinical studies. Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
Associate Medical Director Oncology, Clinical Development
Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions
Translational Medicine G(c)LP Quality Lead
Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for TM vendors contributing to numerous PK & biomarkers assessments in DPI’s pre-clinical and clinical programs
Global Program Lead, Global Regulatory Affairs
Lead, develop and implement the global RA strategy for assigned project. Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams. Present and defend regulatory plans to Debiopharm internal governance bodies.
The Execruit team brings an unparalleled expertise and passion to address your talent recruitment, leadership assessment and development, career development, outplacement and e-learning requirements.
