Director, Clinical Supplies Management

Location:  This position may be performed remotely with travel to the Boston area as needed.

The Opportunity

We are currently searching for a skilled professional to join our team as a Director to lead our Clinical Supplies Management function. The Clinical Supplies Director will oversee all aspects of clinical supply management including forecasting and planning, trial supply management, packaging, labeling, inventory levels monitoring, and distribution activities for the investigational product. The Clinical Supplies Director will also be responsible for selecting and managing external vendors involved in the planning, packaging/labeling, distribution, storage, and destruction of clinical trial supplies.  You'll have responsibility for hiring, training, and developing employees as needed. This position will reside in the CMC group and interface with Clinical Operations, Clinical Development, Quality, and Regulatory.

Primary Responsibilities 

• Provide strategic and operational leadership for the Clinical Supplies Management function.    
• Implement industry best practices by developing, creating, maintaining, and revising processes, SOPs, and Best Practice Guidelines for the clinical supplies function at Praxis Precision Medicines. 
• Evaluate, select, and manage network of third-party providers for packaging, labeling and distribution activities. 
• Interpret clinical study protocols to determine drug supply forecast and inventory requirements. Collaborate with relevant partners to create packaging design based on clinical study needs to ensure optimized supply plan.  
• Lead the development of study specific labels that comply with SOPs and applicable regulations. 
• Responsible for the labeling, distribution, returns, reconciliation, and destruction of supplies to support global clinical studies at all clinical phases of development for both rare diseases and major indications. 
• Manage batch record review and batch release of labeling activities to support clinical supplies. 
• Develop and maintain Pharmacy Manuals in collaboration with clinical operations and clinical development. 
• Responsible for all financial aspects of clinical supplies, including budgeting, forecasting strategic planning, tracking the performance of contract service providers, and review/approval of invoices.   
• Manage internal and third-party deviations, customer complaints, and change controls. 
• Ensure all study related GMP documents are accurate and filed in a timely fashion in the TMF as per Good Manufacturing Practices and Good Clinical Practices guidelines and maintain an inspection ready status. 
• Participate in the selection, design, configuration, and review of IRT systems for drug supply management, accountability, and randomization of global clinical studies. 
• Maintain inspection readiness for activities pertaining to labeling and distribution practices and partner with QA. 
• Hire, train, and manage employees/contractors as needed for the Clinical Supplies function. 

 
Qualifications and Key Success Factors 

• Bachelor’s Degree in supply chain, pharmacy, pharmaceutical sciences, engineering, or related field required. 
• 10+ years of pharmaceutical industry experience with a minimum of 7 years of experience in clinical supplies management. 
• Significant experience in managing global phase I to phase IV clinical studies. 
• Proven track record of effective collaboration and influencing skills with internal partners and external providers. 
• Detailed understanding of Good Manufacturing Practices and Good Distribution Practices requirements, QP requirements, EU GDP’s, Annex 13, CFR regulations and ICH guidelines governing conduct of clinical studies. 
• Project management skills and expertise in outsourcing and vendor management. 
• Experience and understanding of supply chain, including importation process, and customs clearance. 
   

Compensation & Benefits 
 
At Praxis, we’re proud to offer an exceptional benefits package that includes: 

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans 
• Bonus program structured to pay on a quarterly basis 
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth) 
• Wellness benefits of $200/month to cover incredibly flexible options including travel, fitness equipment & memberships, spa services, student loan repayment, sports fees and much more 
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit 
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount) 

To round out this world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.