Associate Director, Clinical Supply Chain
Location: This position may be performed remotely with travel to the Boston area as needed.
The Opportunity
We are hiring a skilled professional to join our team as an Associate Director to manage our Clinical Supplies Management function. You will oversee all aspects of clinical supply management including forecasting and planning, trial supply management, packaging, labeling, inventory levels monitoring, and distribution activities. You will also be responsible for selecting and managing external vendors involved in the planning, packaging/labeling, distribution, storage, and destruction of clinical trial supplies. This position will reside in the CMC group and interface with Clinical Operations, Clinical Development, Quality, and Regulatory.
Primary Responsibilities
- 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 Binder 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.
- 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.
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 6 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 benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, 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.
Annualized Base Salary
$165,000 - $180,000 USD
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
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Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
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