-
ID
#17811793 -
Job type
Permanent -
Salary
TBD -
Source
Boehringer Ingelheim -
Date
2021-07-19 -
Deadline
2021-09-17
Director, Viral Platforms
Connecticut, Ridgefield, 06877 Ridgefield USAPermanent
Vacancy expired!
Description: Description\:
To lead the Viral Platforms group within the Drug Metabolism & Pharmacokinetics Department with responsibility for all pipeline products based on virus technology (oncolytic viruses, cancer vaccines, etc.) The Director will set the strategic direction for the group, which includes establishing the DMPK development path and work packages necessary to drive virus products from start of development to successful registration. The Director will define and implement key milestones for development of viral projects in collaboration with interface functions (Regulatory, NDS, TMCP, Research). The Director will oversee a team of scientists responsible for development of pharmacokinetic assays, immunogenicity assays, and other mechanistic assays in support of the pipeline of products based on viral platforms. Assays will be utilized to support nonclinical and clinical studies. Interfacing with external CROs is also expected.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities\:- Provide leadership to the Viral Platforms team to define and implement processes and assays to support all viral pipeline products within Development globally. Drive innovative science in the area of Viral Platforms to support pipeline products as well as future business needs.
- Mentor DMPK project representatives to provide optimal and consistent support across viral projects in development.
- Focus on talent acquisition, development, and retention in order to build a strong team with experience in viral platforms.
- Develop/maintain strong relationships with key partners in Research and Development at BIPI and with key partners in Biberach, Innsbrouk, and Vienna to facilitate communication and share learnings on viral projects in the pipeline as well as to influence strategies for viral product development.
- Actively participate in external industry/scientific organizations/consortia to influence and to keep informed of industry best practices in the area of virus therapeutics that is evolving rapidly. Keep abreast of evolving Health Authority expectations regarding viral products.
- Ensures compliance with all required training, safety, regulatory, HR, laboratory notebook and intellectual property activities and corporate policies.
- The area of viral therapeutics (ATMP) is evolving rapidly. The Director must keep up with the changes in the regulatory landscape in order to best position BI for interactions with Health Authorities. Work must be done in accordance with Health Authority expectations (e.g., GLP, Google Cloud Platform).
- PhD from an accredited institution in Virology or Immunology with ten-plus (10+) years of experience in the pharmaceutical industry, or BS/MS from an accredited institution in Virology or Immunology with fifteen-plus (15+) years of experience in the pharmaceutical industry.
- Strong scientific background with demonstrated expertise in virology, oncolytic viruses, and immunological assays.
- Ability to build up a team in a new and highly complex scientific area.
- Ability to lead and mentor a diverse group of scientists with different scientific and cultural backgrounds. Ability to effectively interact with different disciplines at local and global sites, to provide input into projects at a practical and intellectual level, and to interface with academic and industrial contacts.
- Ability to effectively lead and manage scientific staff at all levels; This includes providing effective leadership, promoting cooperation and team spirit, making necessary training available and being directly involved in the professional development of personnel.
- Thorough knowledge of evolving regulations and ability to interface with health authorities for inspections or other regulatory interactions (e.g. scientific advice meetings).
- Ability to set strategy for outsourcing and to oversee scientific aspects of external collaborations (academic and/or CRO).
- Requires an in-depth understanding of virology, oncolytic viruses, other viral platforms and the associated assays to evaluate pharmacokinetics, immunogenicity, and biodistribution. High quality and timely study execution, data interpretation, and report generation are necessary to ensure regulatory compliance and project timelines are met. The Director also needs to prioritize work packages to be conducted internally vs. externally based on complexity and resourcing needs.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Vacancy expired!
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