Senior Director Clinical Development Leader- RWEMO

Cambridge, MA

Job Type: Contract | Recruiter: Seamus Webb | Phone: 603.215.7065

Job title: Senior Director Clinical Development 

Location: Fully Remote

Duration 12+ months

Job Description:

In this role, you'll have responsibility for developing and implementing small molecule clinical programs in the therapeutic areas of immunology/inflammation, emphasizing gastrointestinal indications. Candidates must self-direct, collaborate, and  be results-oriented with the creativity, resourcefulness, and adaptability to succeed in a growing company.

Duties:

  • Driving and overseeing the design, execution, analysis, interpretation, and reporting of clinical studies, both early and later staged, in a matrixed and exceptionally collaborative team environment; gastroenterology indication will be emphasized.
  • Developing programmatic clinical strategy and plans together with the cross-organizational project (asset) team, including inputting into all aspects of the integrated development plan.
  • Ensuring patient safety and data integrity- serves as a monitor for clinical studies or hires the necessary resources for service as medical monitoring for clinical studies.
  • Supporting developing and implementing of translational/biomarker plan and helping ensure proper implementation at study sites
  • Leading/authoring clinical portions of regulatory submissions and responding to regulatory agency inquiries.

Qualifications:

  • Doctor of Medicine or Ph.D. with at least five years of related experience in biopharma, including strong small molecule drug development experience and gastrointestinal clinical development
  • Previous experience as a functional leader
  • Vast understanding of biopharma drug development- such as familiarity with relevant ICH and GCP guidelines and regulations
  • Passionate about the development and nurturing of crucial partnerships and collaborations with external parties, as well as internal discovery and preclinical functions
  • Recording important and successful contributions to reg submissions, such as INDs/CTAs, and reg agency interactions
  • A background managing collaborations with additional consultants, pharmaceutical partners, CROs, and other external organizations
  • Interested in serving as a SME across the company

 

POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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