Senior Manager, Clinical Trial Supplies, Oncology - Job ID: 1344NJ

Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.

We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, and Oncology.

Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.

The Senior Manager, Clinical Trial Supplies (CTS), Oncology will work as an integral member of the Ascendis Global CTS Oncology team, managing all aspects of Investigational Medicinal Products (IMP), Clinical Trial Supplies, Comparators and ancillary products used in Ascendis Oncology Clinical Trials. The successful candidate will support the Ascendis CTS Oncology team with sponsored and/or collaborative clinical and non-clinical studies.

The core responsibilities include IMP and comparator forecasting and inventory management, IRT Design and maintenance, CTS team study operations, ownership of distribution tracking for clinical studies, managing in documentation review and archiving to coordinate and track all CTS packaging, labeling, distribution, inventory, returns and destruction of IMP/CTS. The position closely interacts with Clinical Operations, Quality Assurance, and Regulatory groups, and with external vendors as assigned.

 ESSENTIAL DUTIES: 

• Responsible for complex Oncology IMP/CTS forecasting, inventory management and documentation for complex multi-cohort/product types in Ascendis global oncology clinical trials. Must be adept in Microsoft Excel.
• Manage bulk depot and individual site shipments, track and follow through receipt and release to ensure supplies available to sites at all times with minimal to no waste or missed patient doses.
• Coordinate and responsible for pack/label and distribution activities, review, approve and file related documents.
• Represent CTS oncology with IRT URS development, UAT execution, ongoing monitoring and maintaining of IRT reports to provide weekly drug projections.

• Coordinate CMO planning and drive through approvals for labeling (in multiple languages), packaging, inventory, distribution, and reconciliation/returns/final destruction of IMP/CTS for global clinical studies.
• Manage product complaint processing by gathering information, processing and filing of documentation through disposition.
• Consistently verifies status of clinical trials enrollments and ensures depot and sites inventories are monitored and supplied with IMP/CTS required to ensure continuity of supplies, no missed doses.
• Manage review, drive to approval labeling variable data fields, Packaging Specifications, Product shipping and storage specifications etc.
• Provide broader Clinical Supplies Team with document management & administrative support as required.
• Maintain compliance with all applicable Ascendis CTS SOPs re: CTS handling and management and CTS import / export regulations. SOP and WI writing, as assigned.
• Gather data and maintain applicable metrics to monitor performance relative to clinical trial inventory, and planning.
• Attend meetings and responsible for generating, maintaining, and archiving of team meeting minutes and presented materials, as required.
• Provide general CTS support to other projects and products, as assigned.

Requirements

• Bachelor’s degree in applicable discipline and minimum of 7 years professional experience in CTS pharmaceutical or equivalent biotech industry role.
• Experience in supporting management of complex distribution IMP/CTS supply chains for open label, blinded, double-blinded, placebo-controlled clinical trials in global geographies.
• Strong understanding and knowledge of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies a must.
• Demonstrated abilities and knowledge international regulations governing transport and distribution, import/export of CTS materials.
• Minimal travel on company business may be required.

Special skills/knowledge:

• Excellent organizational, written, and verbal communication skills.
• Adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment.
• Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.
• Strong computer software proficiency in spreadsheets, presentations, and word processing software. Advanced Excel skills are a must.
• Accuracy, compliance, and attention to detail is a must.
• GMP manufacture experience of drug products for clinical use.
• Salary range: $165-175K/year

A note to recruiters:

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.  If this occurs your ownership of these candidates will not be acknowledged.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance