Company: Ipsen Bioscience, Inc.
Are you looking for an opportunity to apply your scientific clinical development expertise and business acumen in the neurology therapeutic area?
As Sr. Director Clinical Scientist, Business Development and Translational Medicine in the Neurology Therapeutic Area, you will provide your in-depth understanding of drug development and pharmaceutical marketing in the neurology field. You will support the development and execution of medical & clinical strategy for assigned Ipsen product(s). Additionally, you will support due diligence exercises and develop well thought out strategies and initiatives to capitalize on company business opportunities.
Your role will involve:
Leadership and management within Clinical Development (CD) to provide scientific and clinical development support for products within assigned therapy area.
Support of development and execution of medical & clinical strategy for assigned Ipsen product(s).
Support to the Therapeutic Area Head for the evaluation of Ipsen research/discovery assets and determining the opportunity to translate these assets into clinical development programs
Support to the Therapeutic Area Head for assigned due diligence exercises in close partnership with internal teams to ensure alignment of costs, timings and metrics with Ipsen standards
Support to the Therapeutic Area Head and participate on and providing inputs for the Due Diligence Team, to evaluate target opportunities
Conducting pre-Due Diligence (DD) or DD site visits as needed
Support the due diligence and integration team leading in integration activities to ensure efficient knowledge transfer and efficient integration of acquired assets
Ensuring concise written reports are provided as needed
Acting on behalf of Medical Monitor leading the interpretation of trial data and developing and reviewing clinical study documents, reports etc.
Support Asset Development Lead to provide scientific leadership in execution of clinical trials
Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables
Assist in the review, analysis and reporting of clinical trial data
Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
Provide expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
Lead development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
In return, you will bring:
Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
Significant experience (15+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, or similar organization.
Demonstrated ability to collaborate in a matrixed environment
Experience evaluating pharmaceutical assets brought forward by Business Development and reviewing organizational portfolios to determine translational opportunities
Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
Experience in designing and conducting Phase I-III clinical trials; and/or significant late-stage development research
Availability to travel approximately 25% of time.
If this sounds like an exciting opportunity to work with the Neurology team as Sr. Clinical Scientist, apply today!
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.