Medical Science Director - Neuroscience Job Listing at AstraZeneca in Cambridge (Job ID 1310040241)
The Medical Science Director (MSD) Neuroscience is accountable for the benefit/risk assessment of late stage Neuroscience assets and the ethical integrity of late stage clinical programs. They are accountable for delivering to Global Medicines Development (GMD) Project Teams the Medical/Scientific strategies for clinical components of the Target Product Profile (TPP), Target Product Claims (TPC) and overall Clinical development plans.
The MSD establishes clear design objectives for late stage clinical programs and studies; has accountability for the content of core labelling texts; and provides medical input into commercial activities and the scientific component of the pricing value strategy. The MSD works collaboratively with the iMed medical leadership to support Phase 3 planning and market positioning and effect a smooth medical transition as project accountability moves from the iMed to the GMed.
The MSD leads the Clinical Project Team as well as the Design and Interpretation Working Groups and has accountability for high quality design, delivery and interpretation of clinical programs and studies that define the overall benefit, risk value of the medicinal products for which he/she is accountable. The MSD is responsible for coordinating and integrating all experts required supporting design interpretation activities.
The MSD is accountable for the protection of all human subjects involved in Clinical trials for the compound(s) they oversee. They are also accountable for adherence to the highest ethical standards of Clinical trial conduct and adherence to all GCP requirements concerning human subjects.
Clinical Project Team
Global Product Team
* Leads and is accountable for Design Interpretation Working Groups (DIWGS) in the generation of high quality design options that characterize benefit, risk, and value of medicinal products and focuses on reducing uncertainties for these, while adhering to design interpretation best practices
* Leads discussions to identify the scientific direction and to identify the questions e.g. Design Remit which the next stage of the development programme needs to answer
* Ensures the alignment of all DIWG activities with CPT (and therefore the Global Product Team) objectives and requirements
* Ensures that clinical program/study designs have the appropriate input from experts
* Accountable for the content and quality of all DIWG deliverables
* Accountable for all medical content of design interpretation activities and, in particular, all activities involving assessment of the benefit and risk of the product
* Timely provision of scientific and medical components of commercial activities including the pricing value strategy
* Benefit-risk assessments, risk management plans, and protection of human subjects in clinical studies
* Provides clear recommendations for clinical decision bodies and governance
* Together with the Director of Clinical Development, plans/decides resources for design interpretation activities, supports adherence to AZ standards, and ensures programs adhere to GCP
* Strategic leadership, coaching, mentoring and supervision of team of physicians and scientists aligned to the project(s)
* Works collaboratively across functions (eg Patient Safety, Global Medical Affairs, iMed) to coordinate medical support
* Supports as appropriate within project during issue crisis management as directed by VP Clinical GMed
Education and Experience
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