Director, Due Diligence & Integration, TAT Clinical Programs

Main Responsibilities & Technical Competencies

• TAT Activities:
  • Assess clinical operations activities of the new asset, including gap analyses, and prepare transition plans.
  • Manage clinical study activities delegated by the DDI & TAT CPD, such as project management and monitoring.
  • Oversee CRO clinical and site management activities to ensure adherence to study protocol, regulatory requirements, and GCP guidelines.
  • Conduct site feasibility assessments and organize logistics for sponsor meetings and internal study team meetings.
  • Collaborate with procurement and legal teams on transition plans, contract preparation, and insurance coordination.
  • Coordinate clinical supply logistics, prepare transition plans for clinical study insurance, and track study financial documents.
  • Prepare and execute transition plans for electronic and paper Trial Master Files (TMFs).
  • Support clinical study budget management and monitoring according to financial control processes.
  • Assess and prepare transition plans for clinical asset disclosure of expenses, reporting tools, and regulatory disclosures.
  • Set up and maintain shared CDO transitional folders and study electronic site dashboards.
• Integration Activities:
  • Drive and manage integration activities to ensure effective onboarding and business continuity for acquired clinical assets.
  • Coordinate clinical operation documentation and prepare relevant documents for change control and integration story boards.
  • Communicate with acquired legacy CDO teams and contribute to Q&A sessions.
  • Onboard, mentor, or train new team members as assigned.

EHS Responsibilities

• Comply with applicable EHS regulations and procedures.
• Report risks, malfunctions, or improvements to the site's EHS performance.
• Participate in mandatory EHS training.

Knowledge & Experience

• 15+ years of related experience with a bachelor’s degree, 12+ with a master’s degree, or a doctorate (PharmD/MD/PhD) with 8 years’ experience.
• 6+ years relevant experience within clinical research or study management environment.
• 4+ years clinical trial management experience.
• Strong theoretical or practical administrative and organizational capability in the clinical study environment.
• Experience working with multidisciplinary groups and managing relationships with CROs.
• Excellent organizational and prioritization skills, with strong attention to detail.
• Advanced knowledge of standard software applications (Word, Excel, PowerPoint, Adobe Reader).
• Intermediate financial knowledge with the ability to work with financial tracking tools.
• Good knowledge of Good Clinical Practices (GCP) and other applicable clinical study regulations.
• Experience supporting the transition of clinical assets in or out is advantageous.

Education & Certifications

• Bachelor’s degree in a relevant scientific, clinical, or research focused field required.
• Master’s degree or higher in a relevant scientific, clinical, or research focused field preferred.

Language

• Fluency in English.

Equal Opportunity Employer

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.