Brief Description:
The Senior Manager, Pharmacology Scientist directs, leads, and manages Jazz non-clinical Pharmacology projects from conceptualization and study design through to study report finalization and subsequent scientific publications, and inclusion in regulatory documentation. Manages interactions and collaboration with key stakeholders within non-clinical and across the wider organization.
Essential Functions
1. Directs, leads and manages preclinical pharmacology projects and studies as determined by the needs of the organisation and in accordance with the appropriate Jazz, CRO or researchers SOPs, relevant regulatory guidelines, legislation, best industry and ethical practices, and departmental processes as required per study.
2. Provides strategic input into functional goals and activities; resolves a wide range of issues in creative ways.
3. Operates independently to execute nonclinical project activities and may contribute to new product concepts and defining/optimizing development candidate profiles
4. Is accountable to propose, manage and revise (as appropriate) timelines for pharmacology studies and projects and for timely and effective management of the study and project budget
5. Manages interactions and collaboration with key internal and external CRO or academic stakeholders within non-clinical and across the wider organization including relevant key opinion leaders and academic research organizations; may lead the efforts of other scientists.
6. May be responsible for delegation to others, matrix leadership and/or representing Neuroscience Research on r nonclinical research teams or nonclinical functional matrix teams as required.
7. Defines and manages non-clinical pharmacology study/programme resource needs and establishes relevant contingency/risk mitigation plans.
8. Manage the material requirement for the Jazz Pharmacology studies to ensure that materials are always available
9. Manage and provide technical input into scientific reports from CROs/AROs
10. Contribute to regulatory, pharmacovigilance and medical affairs documents as required to meet corporate needs
11. Contribute to Function and/or Programme (pre-DP0) or Project (post-DP0) Teams as determined within the governance matrix structure
12. Responsible for maintaining own cGxP and H&S knowledge applicable to the job
13. With support from functional leadership, is accountable for devising, agreeing, implementing and monitoring pharmacology team departmental processes and governance structures.
14. Operates in an inclusive manner and demonstrates awareness of the benefits of diversity
15. May manage other scientists as determined by the needs of the organisation
Required Knowledge, Skills, and Abilities
16. Strong industry experience in a similar role
17. A minimum of 5 years’ research experience in Pharmacology department of a pharmaceutical company or equivalent setting
18. Knowledge of the pharmaceutical drug development process
19. Comprehensive knowledge of preclinical drug discovery and development with specific expertise in CNS diseases and neuropharmacology.
20. Extensive knowledge of pharmacology, behaviour and translational readouts of preclinical assays/models.
21. Relevant experience in scientific writing for externalisation (. peer-reviewed scientific publications) and regulatory purposes
22. Competence in budgetary control and management
23. Proven ability of high functioning in a matrix organisation
Required/Preferred Education and Licenses
24. A degree (BSc) and either higher degree (PhD or MSC) in Pharmacology or another appropriate scientific discipline or equivalent significant drug discovery experience (Neuroscience)