Associate Director, Clinical Trial Supply: Job ID-1188

Ascendis Pharma

Ascendis Pharma

Palo Alto, CA, USA
Posted on Tuesday, August 29, 2023

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in the United States, Denmark, and Germany. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company with an independent pipeline of long-acting prodrug therapies that address unmet patient needs. We have successfully launched our first innovative product in the US, and on the brink of expansion into new disease categories.

At Ascendis, we strive to make meaningful improvements in patients’ lives. We make business decisions on patient’s needs and we do our best every day to realize our products’ benefits for our patients. We are passionate about realizing our shared vision and goals. We trust each other’s strengths, and when we face challenges, we remain optimistic and committed to working together as one team to achieve extraordinary results.

This Senior Manager, Clinical Trial Supply will join a team of 16 Clinical Supply colleagues (based in Denmark). This person will be managing clinical trial supplies for assigned studies ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements.

  • Responsible for all aspects of the Clinical Trial Supply Chain from CMOs to clinical sites (Phase 1-3) in global trials in accordance with regulatory, cGMP and cGDP requirements
  • Representing CTS in trial team meetings and CMC meetings
  • Planning and forecasting of supplies in collaboration with internal stakeholders e.g. CMC, Trial Management, Regulatory Affairs
  • Oversight, coordination, and collaboration with subcontractors and CMOs to ensure delivery of IMP and related materials at the right time and quality level
  • Reviewing and approving documentation from subcontractors and CMOs
  • IRT system user as well as reviewing and approving URS
  • Preparing and reviewing SOPs, deviations, complaints and CAPAs
  • Responsible for supporting QA in any relevant matter during conduct of the clinical trials
  • Responsible for supporting other CTS teams as applicable
  • Planning, sourcing, preparing, surveillance and facilitating of IMP and related materials for clinical trials
  • Preparing pharmacy manuals and other documents relevant to clinical trials
  • Review of internal documentation (Protocol, instructions, manuals, e.g.) used in the conduct of the clinical trials
  • Participation and collaboration in internal and external teams as relevant for the clinical trials and related activities
  • Handling temperature excursions
  • Master’s Degree, Bachelor’s Degree (or equivalent) level of qualification in Pharmacy, Life Sciences, Medicine, Nursing or related field equivalent
  • Oncology experience highly preferred but not required
  • 6+ years of experience from a similar position a pharmaceutical, biotechnology company or contract research organization (CRO) in clinical trial supplies management
  • Strong knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Clinical Practice and ICH guidelines, and other applicable regulatory requirements
  • Strong organizational skills and detail oriented
  • Strong ability to manage time and work independently
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
  • Ability to travel up to 10% of the time domestically and internationally
  • Estimated annual salary 165-185K/year DOE
  • Hybrid role requiring 3 days of onsite work in Palo Alto, CA each week
  • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance