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Associate Director, Clinical Pharmacology

Your role:

  • As a clinical pharmacology (CP) expert, you will support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the general population and subpopulations. 
  • Provide comprehensive understanding and interpretation of PK and/or PK-PD for protocol development as well as study report completion
  • In a matrix team, and in close collaboration with experts from Quantitative Pharmacology (QP), design and implement the QP strategy, which includes the Clinical Pharmacology aspects, to advance the assigned projects.
  • Provide leadership for risk assessment, mitigations, scenarios and proactive planning to ensure synergy and innovation among functions
  • Independently leads the CP effort regarding PK and/or PK-PD data by developing/executing plans, review the results and communicating results to the study team.
  • Provide expertise and know-how in designing and implementing CP strategy in clinical trials during all clinical phases
  • Represent CP to interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to CP and drug development
  • Act as a CP member to support QP in all its endeavors with respect to moving drug/product candidates up to Proof of Concept decision point and beyond.
  • Support or improve the established processes and contribute to a supportive environment
  • Contribute to continuous learning, keep abreast with current technology and updated with best practice within the Department
  • Drive initiatives, lessons learned and best practices
  • May act as a part-time or full-time Translational Project Lead as needed

 

Who you are:

  • PhD in pharmacokinetics, (bio)pharmaceutics, pharmacology, or related field, PharmD, or MD in Clinical Pharmacology is strongly preferred.
  • Bachelor’s degree with 8+ years of experience, master’s degree with 3+ years of experience, or PhD is required.
  • Direct industrial experience for minimal 5 years of experience is strongly preferred.
  • Proficient English is required
  • Skills with data analysis and experience in drug development in EMD Serono core therapeutic areas and modalities is a plus.
  • The candidate should also have excellent written and verbal communication, organization and interpersonal skills, be a strong team-player and be fully at ease in a matrix environment.
Job Requisition ID:  187012
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.


Nearest Major Market: Boston

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