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Director, Clinical Operations Program Management - Oncology (Rockland or Billerica, MA)

An exciting opportunity has arisen to join EMD Serono as a member of the Program Leadership Team within Regional Clinical Operations (RCO) – responsible for a varied portfolio of post-marketing Company Sponsored Clinical Studies, plus Collaborative Research Studies and Investigator Sponsored Studies for both marketed and pipeline compounds.

 

Your role:

 

As a Clinical Operations Program Lead you will drive performance of studies for your assigned compound(s) and contribute to company strategic objectives.  Responsible for coordinating study management activities at the compound level across all therapeutic areas for: Phase IV Clinical Studies; Collaborative Research Studies and Investigator Sponsored Studies (ISS) for marketed and pipeline compounds; as well as Early/Expanded Access activities.  The role may also involve CRO oversight at the governance level for operational activities and deliverables.  

 

Who you are:  

 

Expert knowledge of clinical operations, extensive experience in clinical study planning and conduct, and thorough knowledge of ICH GCP and global/local country regulations.

 

Minimum qualifications:

 

  • Bachelor’s degree with 10 plus years, master’s degree with 5 plus years, or PhD with 3 plus years of experience
     

Preferred qualifications:

 

  • Advance degree preferred
  • A minimum of 12 years clinical operations experience from a CRO, pharma or biotech company. 
  • Ability to build and lead high-performing teams in a matrix organization
  • Strong communication skills – verbal, written and listening – both in native language and English
  • Proactive, deliverable focused and solution orientated with clear understanding of ownership and accountability
  • Capability to work independently on assigned tasks or projects of increasing complexity
  • Flexible, adaptable and able to approach change positively and adjust behaviors accordingly
  • Aptitude to network and use appropriate interpersonal styles to establish constructive working relationships with peers and partners to meet mutual goals and objectives
  • Broad therapeutic area experience ideally relevant to our company portfolio

 

This role can sit at our Rockland or Billerica, Massachusetts location.

Job Requisition ID:  202547
Location:  Rockland
Career Level:  E - Professional (10+ 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

Job Segment: Oncology, Clinic, Biotech, Manager, Program Manager, Healthcare, Science, Management

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