Clinical Development Cns
hace 3 semanas
One area of significant investment is to build internal infrastructure to be a leader in next generation of products in CNS. Possess a clinical background and are driven by science and the desire to develop therapies for cancer patients. You will have a proficiency in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully.
**Responsibilities**:
Provide long-range clinical planning in early clinical trial development, planning and managing of clinical research projects and clinical development programs in CNS.
Serve as the Project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development.
Contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
Play a role in designing clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical CNS.
Participate in identification, selection and conduct of negotiations with clinical research centers and investigators.
Participate in the selection and management activities of CROs; Supervise project team members in planning, conducting and evaluating clinical trials.
Lead all aspects of planning and management of investigator meetings, advisory boards and other scientific committees.
**Essential Requirements**:
University degree in human sciences, pharmacology or medicine, preferably M.D degree.
Strong preference for individuals with clinical training in CNS.
At least 3 years of experience in clinical research and/or CNS drug development in pharmaceutical, academic or CRO environment.
**Preferred Requirements**:
PhD in a relevant research area is preferred.
Significant experience in the pharmaceutical/life sciences industry in a function aligned to clinical development and early or late stage clinical trials.
Excellent oral and written skills, strong interpersonal and listening skills with a focus on results and sound outcomes.
Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
High level of emotional intelligence, able to deal with ambiguity.
Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams.
Experience in molecular CNS and/or translational science.
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