Senior Director, Toxicology job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
|Category:||Research and Development|
Position Description: Director/Senior Director of toxicology with a focus on safety and translational sciences aspects of ADC drug development. This position will be reporting directly to the Vice President of Global Safety Assessment. |
Major Responsibilities :
•Responsible for the successful operation of activities of major significance (e.g., filing of discovery, mechanistic toxicology projects, INDs and BLAs) to the biologics safety assessment and translational sciences
•Global Biologics R &D cross-functional strategic and advisory role as an Antibody Drug Conjugates thought leader
•The position will provide strategic support and guidance on ADC safety-toxicology to all project toxicologists as well as other scientists in translational sciences/medicine functions..
•Support activities will be on ensuring consistency in nonclinical strategy for early and late stage ADC projects. With respect to late stage projects (Phase II and beyond), focus will be on BLA and label writing, extractables & leachables, safety strategy, regulatory strategy and interactions and post-marketing activities.
•Lead to advance the ADC pipeline from early discovery to clinical development, by developing and implementing consistent nonclinical PK/PD and safety strategies
•Manages the ADC safety sciences and business strategies, plans and actions and uses broad scientific knowledge and experience to manage the outcomes and actions of a variety of projects across a toxicology functional area.
•Responsible for implementing learnings from late stage projects into early stage projects, and for guiding and directing the global implementation of novel translational platforms (e.g. humanized mouse models) to assess ADC and IMT-C combination PK/PD and safety, with the aim to improve translational value and predictivity.
Education: Ph.D. /DVM/DVM-Ph.D. in relevant discipline of biological sciences with specialization in safety sciences with at least 15 years of experience in oncology drug development, including ADC projects
•At least 15 years of post-Ph.D. experience with a minimum of 10 years' experience in Biologics
•Must have strong toxicology background (board certification in Toxicology is highly desirable) and drug development experience
•The candidate must have a proven record in filing INDs, BLAs etc.
•Must have a strong understanding of biologics drug development, oncology (e.g., immunotherapy of cancer), with specialization in ADCs
General Scope, Knowledge, and Qualifications
•Develops and leads Early discovery, early clinical and late stage and plans to advance numerous scientific opportunities.
•Creates competitive and breakthrough strategies and plans.
•Communicates a compelling vision and sense of purpose in ADCs
•Responsible for the overall leadership and operational success of assigned functions, and for successfully integrating these activities with those of other major organizational segments.
•Strong leadership and effective management skills
•Innovative, creative and able to influence others in a positive manner
•Strong communication, organizational and interpersonal skills to work matrix setting, manages projects and team members in a matrix environment.
•Problem solving and organizational skills with attention to details related to drug development.
•Strong team player and strong motivational skills.
•Strong publication record in toxicology/pharmacology
•Strong experience in MECHANISTIC AND MOLECULAR TOXICOLOGY of Small and Large Molecule drugs
•Applies knowledge of current and future industry trends and how they will affect the business.
•Knows the competition and how strategies and tactics work in the marketplace.
•Demonstrates broad knowledge and perspective outside of own organizational segment.
Next Steps - Apply today!
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MedImmune is an equal opportunity employer. MedImmune will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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