Lead the No-Clinical development team including the core disciplines (Pharmacology, Non-Clinical Biology, DMPK/ and in vivo Pharmacology/Toxicology) to ensure high quality, scientifically rigorous, and timely delivery of the Non-Clinical IND package to best align with the clinical and regulatory strategy.
Serve as a spokesperson for programs and remain accountable for team deliverables and value creation.
Create and own a product development plan in partnership with functional leaders to govern project strategy.
Drive strategies to inform and advance discovery, development, and regulatory affairs.
Provide leadership around the design, execution, interpretation, and reporting of toxicity and safety pharmacology studies including assessment of potential relevance of findings on human safety.
Maintain project timelines with input from the functional departments and scientific project leaders, ensuring that project timelines align with corporate goals.
Proactively identify and communicate risks in the project timelines regarding key milestones and deliverables and work closely with the scientific and functional leaders to mitigate downstream impacts.
Assist scientific project leaders foster high-performing teams through the creation of team norms and operating principles.
Facilitate effective, science-based business decisions including scenario planning, highlighting all potential downstream impacts of strategic decision making (including resource allocation, team capacity, risk and overall portfolio management).
Develop and coordinate ongoing resource planning across functions to ensure adequate resources are applied to the project at any given time.
Drive annual operating budget planning for programs. Together with Finance, support the tracking of actuals to budget and communicate deviations to budget and prospectively identify variations throughout the year.
Manage the scientific communications plans for the project(s) and integrate with overall corporate communications plan
Prepare and present monthly progress reports and ad hoc reports as required
Responsible for the conduct and deliverables of Project Team meetings.
Additional responsibilities as needed.
PhD and 10+ years of biotech/pharma experience or BS/MS in a scientific discipline with 15+ years of biotech/pharm experience. Prior involvement on biologics development programs required.
4+ years of experience leading multi-disciplinary Non-Clinical Development Teams highly preferred.
Demonstrated leadership skills, has an easily recognized executive presence, and is a proven relationship builder who is effective via influence.
Deep experience working with and leading Pharmacology, Non-Clinical Biology, DMPK/ and in vivo Pharmacology/Toxicology.
Demonstrated experience leading successful scientific programs that have progressed from discovery to (and beyond) in – vivo studies. Prior experience with a variety of animal models.
Proven track record of effective interpersonal and communication skills with ability to develop strong positive relationship with all levels of the organization.
Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
Requires a strong understanding of overall drug development strategies, spanning across all critical product development disciplines (non-clinical, clinical, CMC, RA/QA, commercial strategy and development).
Working knowledge of GXPs and other applicable compliance requirements.
Core competency for the application of traditional program management principles and practices.
Salary: On application
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