Sr. Director, Pharmacology & Toxicology - United States, United Kingdom, Switzerland
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- Responsible for the Global Toxicology/Pharmacology function across all disciplines at company Therapeutics.
- Responsibilities include overall non-clinical safety and Pharm/Tox strategy for Research and Development and support for CMC/Tech Ops, clinical and regulatory functions, ensuring appropriate resourcing for and execution of all non-clinical safety programs, studies and reports, compilation of the non-clinical content for regulatory submissions and related documents, appropriate input into senior-level governance activities and global safety reviews, support for manufacturing, clinical, regulatory and diligence activities as appropriate, and ensuring the highest quality standards consistent with regulatory guidance, evolving industry standards in the field and proactive creation of standards in this new field of gene-editing.
- Develops, oversees and directs the overall Pharm/Tox strategy for all Research and Development programs, including appropriate and time and cost efficient support for all programs at our company Therapeutics throughout the drug development life-cycle.
- Oversees, ensures appropriate resourcing for, and directs all Pharm/Tox activities beginning with in vitro and in vivo studies to support initial first in human (FIH) evaluation and throughout the development process, including post approval; ensures support for Tech Ops as needed.
- Oversees and evaluates protocol preparation for Pharm/Tox studies. Designs and directs Pharm/Tox and studies through external vendors and by internal staff. Reviews study designs and insures that all inter-dependencies within the Pharm/Tox process (e.g. Bio-analytical, CMC and Quality and Clinical) are aligned and the Pharm/Tox function is fully prepared to support the execution of each study.
- Ensures that Pharm/Tox studies and assay sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO). Where appropriate, leads and/or engages in discussions with industry groups and regulatory authorities to address opportunities to expedite the development of novel transformative gene-editing based drugs for the treatment of life-threatening conditions that may require more creative, less traditional or guideline-based approach to toxicological aspects of drug development (while maintaining an assurance of patient safety).
- Such discussions will occur in collaboration with Regulatory Affairs and other key stakeholders.
- Performs research and/or development in collaboration with other functions in projects pertaining to Pharm/Tox, including additional investigational or non-standard studies to understand and mitigate any adverse observations.
- Ensures quality and timely submission of all Pharm/Tox-related documents and materials for regulatory filings, including pre-IND or scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
- Represents Pharm/Tox discipline on Senior Level Management and Governance Committees to insure the quality and continuity in, and appropriate management of Pharm/Tox assessment for all programs in Research and Development.
- Ensures Pharm/Tox representation on all Development Teams where needed.
- Works as part of a multidisciplinary team to support the conduct of non-clinical studies.
- Provides support to multidisciplinary research project teams in areas such as genomics, DNA sequence analysis, biology and pathology.
- Oversees the construction and maintenance of technical databases, archives and department procedures manuals required for the Toxicology function.
- Doctoral degree and post-doctoral training in a field related to industrial Pharmacology & Toxicology
- 8 years experience as nonclinical toxicologist in a biotech or pharmaceutical setting
- Experience leading a Global Toxicology function including managing multiple programs and priorities, studies, external CRO management, staff and budgets.
- Deep understanding of the evolving regulatory requirements for cell and gene therapy (OTAT) products in the US or ATMP products in Europe.
- Experience with development of Cell and Gene Therapy or ATMP products, and bioassay requirements
- 15+ years experience as nonclinical toxicologist in a biotech or pharmaceutical setting
- Prior start-up company experience
- Creativity/Innovation - creating a boundary-less environment that fosters curiosity and taking risks, openness to new approaches, diversity of new thought, blank page creativity and opportunistic thinking.
- Job Knowledge – Achieves and maintains technical and professional proficiency related to current job position and areas of expertise.
- Decision Making - The ability to make sound decisions using judgment by evaluating all factors involved and potential impact.
- Results Orientation - Drives issues to closure and gets the job done.
- Attention to Detail – ensures all the fine points and details are completed.
- Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.