Posted to MedZilla on 5/24/2017


Takeda Pharmaceuticals

US-MA, Scientific Director, Vaccine Lead 1700533-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

  • Develop nonclinical safety strategies to meet global requirements for all vaccine discovery and development programs
  • Lead preclinical safety program across the VBU organization
  • Responsible for preclinical regulatory strategy, documentation and regulatory interactions
  • Lead team to conduct nonclinical safety, immunogenicity and efficacy testing programs for candidate vaccines in discovery and development

ACCOUNTABILITIES:

  • Develop nonclinical safety strategies to meet global regulatory requirements for all vaccine discovery and development programs.
  • Prepare all nonclinical regulatory documents and address questions and additional requirements from regulatory authorities. Represent nonclinical safety and efficacy at relevant international regulatory meetings (e.g. FDA, EMA, WHO, MHRA, MHLW, PEI, etc.)
  • Lead the design preclinical studies to address safety concerns prior to and during clinical trials.
  • Lead nonclinical safety, immunogenicity and efficacy testing programs for candidate vaccines in discovery and development, including selection of qualified contract research organizations, interaction with study directors, monitoring, data interpretation and report approval for regulatory submissions
  • Direct team of Ph.D. scientists and research associates to execute nonclinical vaccine immunogenicity and efficacy studies of preclinical and early clinical stage candidate vaccines, internally and with academic and contract laboratories, including promoting a culture of team accomplishment and providing career development.
  • Lead preclinical safety cross-functionally across the organization including with Global Project Teams, Regulatory, Clinical, Quality and Manufacturing.
  • Present strategies, plans, status and results in internal and external meetings and publications.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Ph.D. in a scientific discipline with a minimum of 15 years vaccine development experience, MS in a scientific discipline with a minimum of 18 years vaccine development experience, or a BS in a scientific discipline with a minimum of 20 years vaccine development experience.
  • Minimum of 15 years experience in pharmaceutical research and/or development and at least 5 years working on vaccine preclinical development of products in a management position.
  • Proven ability to design and execute nonclinical safety testing of vaccines meeting global regulatory requirements and incorporating knowledge of potential mechanisms of vaccine toxicity. .
  • Experience in writing scientific and regulatory documents. Must have strong verbal and written communication and negotiation skills.
  • Working knowledge of GLP practices
  • Scientific management experience, including demonstrated experience managing laboratory personnel in a team environment and a working knowledge of scientific project management.
  • Well connected in the vaccine preclinical safety field, with proven track record of establishing and managing collaborative projects.
  • Compliance with Takeda safety practices and standard operating procedures.
  • Exhibit and promote Takeda Core Competencies


LICENSES/CERTIFICATIONS:
  • Comply with institutional certifications and requirements in a BSL-2 environment, including shipping regulations for infectious agents.
  • DABT desirable
PHYSICAL DEMANDS:
  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Typical office and laboratory bending, stooping, lifting requirements apply.
TRAVEL REQUIREMENTS:

  • Position requires up to 25% travel
  • International travel will be required



we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-KB1-VBU


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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