Associate Director of New Biological Entities (DMPK)

Posted 04 Apr 2019

Billerica, Massachusetts - United States

Req Id 190533

Details

 

A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.

 


Your role:

This strategic, scientific and operational Project Representative role supports development of new biological entities (NBE: biopharmaceuticals, antibody-drug conjugates). They will be responsible for managing overall immunogenicity and nonclinical drug disposition (i.e. Adsorption, Distribution, Metabolism, Excretion) contributions to NBE projects from hit discovery through life cycle management, thus fulfilling internal and regulatory requirements.

They will be responsible for defining the appropriate project plan, ensuring that studies are conducted on time and with the required quality, and scientific content of regulatory submissions. They will qualitatively integrate the various bioanalytical and immunogenicity data to interpret the drug disposition of the NBE and to perform the immunogenicity risk assessment for assigned projects. They will collaborate with the cross-functional Discovery Project Team for research projects and the Translational team for development projects.

Who you are:

  • PhD with 5 plus years of experience drug discovery/development of biopharmaceuticals strongly preferred
  • Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD minimum requirement
  • Excellent knowledge of drug development & discovery processes
  • Subject matter expert for immunogenicity and/or nonclinical DMPK
  • Solid understanding of translational sciences, regulatory requirements
  • General knowledge of disease biology and pharmacology
  • Strong leadership and influencing skills
  • Good intercultural understanding
  • Fluent spoken/written English

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

 



The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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