As our business expands, we are creating new positions to support and enable growth and looking for highly-energetic, self-motivated leaders that are seeking a fulfilling career to complement our experienced team.
If you possess these qualities and seek the opportunity to work in an entrepreneurial environment with a chance to make a difference and help patients, email your credentials today.
Join Our Team
- Manager, Clinical Supplies
The Manager, Clinical Supplies is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP manufacture and distribution process for all planned/ongoing clinical trials. The role will ensure activities are performed on time, within budget and with good quality, in compliance with all required regulations/guidelines and relevant Marinus procedures. This role applies to internally sourced studies and CRO Partnered studies. Collaborates and interacts with clinical trial managers, study project managers, medical monitors, as well as staff from quality, regulatory, CMC, and relevant vendors.
- Facilitate logistics to support the manufacture, packaging, labeling and shipment of Investigational Product to vendors, depots, and/or investigative sites, as well as other clinical supplies as needed.
- Communicate, support and issue resolution for site-facing drug supply-managed processes and on-site drug supply issues.
- Assist in the execution of user acceptance testing for IRT systems.
- Monitor inventory levels at vendors, depots and investigative sites.
- Monitor distribution activities.
- Ensure work is completed in compliance with Marinus Standard Operating Procedures (SOPs).
- Assist in the oversight activities performed by third party vendors.
- Assist in the development of drug supply training materials for investigative sites.
- Serves as lead for the functional area in supply planning, including demand forecasting
- Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan
- Works with clinical logistics management to determine resourcing needs
- Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals, etc.
- Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines
Inventory tracking and shipments
- Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.
- Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites.
Returns & Destruction
- Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.
- Authorizes final destruction or drug returns to 3rd party vendor.
- Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.
- Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
- Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
- Provides input to drug kit randomization specifications and reviews and master kit lists
- Reviews IVRS specifications and user manuals
- Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed.
- Supports inspection team in preparation for and during regulatory agency inspection.
Study Team Interaction
- Attends cross-functional study team meetings.
- Provides input into budgets, SoWs, contracts and timelines for IP-related services
- Prepares or provides input into IP-related content for training materials and coordinates training on study procedures
- Establishes study team contacts, roles, responsibilities, and objectives for IP-related services
- Develops, manages, and maintains relationships with external partners
- Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution
- Acts as point of escalation for IP-related issues.
- Leads management of IP service vendors (performance, quality, timelines, deliverables, costs)
- Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS)
- Provides input, reviews, and approves vendor study specifications
- Serves as point of escalation for vendor-related IP issues as they arise
- Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated;
Attributes/Behavioral Traits: (These reflect the culture and values and describe the what needed and expected in the performance of the position)
- Integrity and Trust
- Dealing with Ambiguity
- Learning on the Fly
- Influencing others
- Process Management
Required Education and Experience: (This section needs to address the job requirements specifically and may include a combination of education and experience)
- Bachelor’s degree and at least 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management
- Experience developing trial drug supply plans
- Experience with supply management applications -- “Dive”
- Investigational Product forecasting skills
- Working knowledge of the clinical drug development process and clinical trial methodology
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Familiarity with IV and acute care products or epilepsy knowledge (a plus)
- Negotiation skills
- Ability to effectively multi-task and prioritize
- Effective problem-solving skills
- Written and verbal communication and presentation skills in small and large group settings
- Project management and organizational skills
- Interpersonal skills
- Cross functional and cross-cultural awareness
- Must possess the ability to work independently and thrive in a fast-paced environment.
- Strong knowledge of applicable computer and project management software preferred
- Excellent written and oral communication skills required
Marinus is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Explore the Benefits
Marinus is committed to a culturally diverse workforce, and offers employees an attractive package of compensation and benefits, including:
- Short Term Disability
- Long Term Disability
- Paid Holidays
- 401(k) Savings and Investment Plan
- Health Insurance
- Dental Insurance
- Life and AD&D Insurance
- Equity Compensation
Our goal at Marinus is to improve the lives of patients and families who suffer from neuropsychiatric disorders. Ganaxolone utilizes an endogenous mechanism of action to modulate the GABAA system in the brain.