[Close] 

Assoc VP, Toxicology

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.?Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.


Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective?therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. ?Power your future & join our bold team.

Position Overview

The Non-Clinical and Translational Sciences organization at Allergan, Inc. is seeking an Associate Vice President to lead our department of experienced toxicology/pathology scientists.? This role has responsibility for non-clinical safety evaluation for all Allergan pharmaceutical products, in research, development or on the market. ?In that capacity the incumbent will provide strong technical, scientific, and administrative leadership in the areas of toxicology and pathology.? The incumbent functions as the company toxicology expert and provides guidance for interpretation of results of safety studies, risk assessments and positioning adverse findings. ?Incumbent must have a comprehensive understanding of toxicology, pharmacology, biomarkers (both pharmacology and safety), pharmacokinetics and drug metabolism and strong knowledge/interest in animal models of disease, biological model systems, incorporation of the 3Rs and the USDA requirements for animal welfare. S/he must have extensive experience with laboratory animal species used in safety assessment, including non-human primates.? In this role, the incumbent will play an influential role in the evaluation of in-licensing candidates and review of non-clinical development program strategies.??

S/he is responsible for overall direction for toxicology, anatomic and clinical pathology serving drug discovery and development and for developing and implementing standards for the practice of non-clinical safety assessment in Allergan.? Incumbent is also recognized in the toxicology/pathology community outside of Allergan and has participated in the formulation of best practices for the field.? S/he ensures that the extent of non-clinical toxicopathology evaluations meet or exceed international regulatory requirements and their timely implementation through in-house or Contract Research Organizations (CROs) in full compliance with GLP regulations.?

S/he directly supervises and develops toxicologists, pathologists and other professionals to ensure functional and impactful representation on sub-teams involved in drug development and issue management.? Contributes to and provides oversight to the preparation of relevant sections of world-wide IND/NDA/BLA/CTD summaries for regulatory submissions and provides technical response to inquiries related to non-clinical findings and interpretations.? Provides technical review support for potential in-licensing opportunities.

S/he will be an active member on the department leadership team.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

Main Areas of Responsibilities



  • Provide leadership to assure appropriate support to all projects across all Therapeutic Areas in Allergan?s pharmaceutical portfolio.? Review and approve study plans and discuss and interpret data. Directs and participates in reviews of INDs, NDAs, BLAs, CTDs, and CIBs, assuring accuracy, completeness, and timeliness for regulatory submissions.? Reviews cost and timing for development of potential acquisitions and new technologies. Assures strong safety assessment related due diligence capabilities can be brought to Open Science opportunities.


  • Supervise Toxicology, Pathology staff at two sites to generate high quality and rigorous data in-house and externally via CROs.? Verifies that overall toxicology & pathology contributions to study reports are of high quality and consistent with ICH and industry standards and guidelines supporting human clinical trials, and as a part of regulatory submissions. Incumbent ensures that requirements for CRO pathology support through interaction with CRO partners and establishing a robust program for peer review of pathology interpretations.?? Leads the function as an integrated bi-coastal team of scientists.? Builds and maintains strong partnership with the External Science and Monitoring team in respect of all CRO interactions.?


  • Provides expert opinion on non-clinical safety and risk assessment matters to senior R&D management, internal Governance Boards and other R&D committees as required.


  • As a member of the Non-Clinical and Translational Sciences leadership team supports and takes ownership across departmental initiatives that build the capability and effectiveness of the department.


  • Promotes scientific and career development for staff.? Mentor scientists through review of key decisions, issue resolution and responses to regulatory inquiries.? Ensures viable succession plan and readiness of candidate successors for roles in NTS and elsewhere in Allergan as necessary.?


  • Participate as a member of the Non-Clinical and Translational Sciences leadership team, that includes Clinical Pharmacology, Metabolism, Immunology and other supporting functions, actively participating in strategic and interdepartmental discussions and partnering with key leaders cross functionally.


  • Partner cross functionally, cross site, and cross departmentally to ensure continued advancement of science, development of staff within department, and building bridges for further process improvements.




Requirements



  • Direct line management experience leading scientific teams in a pharmaceutical drug development environment, preferably across multiple sites.


  • Experience interacting with regulatory authorities.



?

Preferred Skills/Qualification



  • A minimum of 15 years of pharmaceutical experience in drug discovery and development.


  • Effective and trusted communicator, with ability to ask insightful questions, be unbiased in assessments and can effectively communicate and influence across all levels of the organization.


  • Travel required within US to assure team cohesion and effective leadership (20-25%). International travel possible. Travel to attend regulatory meetings as required.



Education

Ph.D./DVM Board certification in Toxicology preferred and will consider Pathology.

LI-DM1


 

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Assoc Dir, Regulatory Affairs CMC
Madison, NJ Allergan
Assoc Director Reg Affairs
Jersey City, NJ Noven Pharmaceuticals, Inc.
Assoc Dir Clinical Pharm Srvs
Camden, NJ Cooper University Health Care
Nurse Assoc/us PICU
Camden, NJ Cooper University Health Care
Sr Manager, Assoc Biologics CMC Program Leader
Summit, NJ Celgene Corporation