Associate Director Of New Biological Entities (Dmpk)

Merck Kgaa Billerica , MA 01821

Posted 2 weeks ago

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

Job Requisition ID: 190533

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure

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.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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Associate Director Of New Biological Entities (Dmpk)

Merck Kgaa