Global Clinical Program Leader — Medical Director

CSL

Waltham (MA)

Hybrid

USD 300,000 - 376,000

Full time

3 days ago
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Benefits offered by this job

Hybrid work model

Job summary

CSL Behring in Waltham, MA is seeking a senior Clinical Development leader for a hybrid role with 3 onsite days per week. You will guide cross-functional clinical programs, ensure GCP/ICH compliance, and drive development plans for internal pre-clinical assets.

The position requires MD/PhD/PharmD with extensive clinical development experience, strong leadership in a matrix environment, and solid regulatory knowledge.

Qualifications

  • Extensive clinical development pharmaceutical/biotech experience with regulatory knowledge.
  • 3+ years relevant clinical development experience including study data review and evaluation.
  • Demonstrated leadership in a matrix environment and stakeholder management.

Responsibilities

  • Serve as a clinical representative on due diligence teams evaluating external assets and prepare CDPs and slides.
  • Develop high-level target product profiles for pre-clinical internal assets.
  • Lead the Clinical Development Team (CDT) and maintain the Clinical Development Plan (CDP).
  • Ensure alignment with GCP and ICH regulations and cross-functional stakeholder alignment.
  • Present results to Safety Monitoring, STRC/SDC committees and other forums.
  • Contribute to due diligence projects supporting CSL’s external innovation efforts.

Skills

MD/PhD/PharmD
Board Certified
Clinical development
Leadership in matrix
Regulatory knowledge

Education

MD, PhD or PharmD

Job description

CSL Behring in Waltham, MA is seeking a senior Clinical Development leader for a hybrid role with 3 onsite days per week. You will guide cross-functional clinical programs, ensure GCP/ICH compliance, and drive development plans for internal pre-clinical assets.

The position requires MD/PhD/PharmD with extensive clinical development experience, strong leadership in a matrix environment, and solid regulatory knowledge.

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