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Clinical Development Director

10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Development Director
Location: Collegeville, PA; Stevenage, UK; London, UK; Waltham, MA; Durham, NC
Department: Medical and Clinical
Job ID: 406756


Work Experience Required:

Minimum Experience:

  • Bachelor’s degree in a science-related field (Infectious Disease preferred):
  • Experience participating in global initiatives:
  • Experience managing large programs:

Preferred Experience:

  • Advanced Degree (MS, PhD, MD):
  • Demonstrated leadership success with a strong record of performance and delivery:
  • Experience in change management and leading teams through transition:
  • Strong strategic assessment and decision-making skills in clinical study design:
  • Experience engaging with external scientific experts, including regulators, payors, CROs, consultants, and investigators:
  • Expertise in clinical research and biostatistics principles for clinical trial design:
  • Proven ability to analyze, interpret, and critically evaluate clinical and digital data:
  • Ability to work collaboratively with multiple stakeholders in a matrix environment:

Key Responsibilities Gained from Experience:

  • Study Design and Strategy

    • Developed clinical study designs integrating input from internal and external experts:
    • Ensured study objectives aligned with clinical development plans and decision criteria:
    • Presented scientific rationale and study design at investigator meetings:
  • Scientific Oversight and Monitoring

    • Maintained benefit-risk assessment throughout the study:
    • Ensured alignment of study analysis plans with protocol objectives:
    • Provided clinical oversight, including monitoring patient safety and protocol deviations:
  • Evidence Generation and Study Outputs

    • Led the interpretation of study data for clinical study reports and scientific publications:
    • Prepared study results for presentations at scientific meetings, congresses, and regulatory submissions:
    • Provided scientific content for regulatory interactions and documentation:
  • Cross-Functional Collaboration

    • Partnered with study delivery teams for optimal study execution:
    • Worked closely with regulatory affairs, medical affairs, and clinical trial operations:
    • Ensured seamless coordination across safety, compliance, and evidence-generation teams: