We are searching for a skilled professional to join our team as Sr Manager of Clinical Supplies Management. In this role you will be responsible for forecasting and planning, trial supply management, packaging, labeling, inventory levels monitoring, and distribution activities for the investigational product in support of clinical trials. You will also oversee execution of packaging/labeling, distribution, storage, and destruction of clinical trial supplies at external vendors. This position is in our CMC group and interfaces with Clinical Operations, Clinical Development, Quality, Regulatory, and Finance among other groups.
Primary Responsibilities
1. Manage clinical supplies end to end activities for multiple clinical trials.
2. Oversee packaging, labeling and distribution activities conducted at contract service providers, including request and review of proposals, communication of project requirements, and management of project execution.
3. 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.
4. Manage the development of study specific labels that comply with SOPs and applicable regulations.
5. 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.
6. Manage batch record review and release of packaging/labeling activities of clinical supplies.
7. Manage inventory levels at depots and sites to ensure supply continuity, identify risks, and minimize waste.
8. Develop and maintain Pharmacy Manuals in collaboration with clinical operations and clinical development.
9. Responsibilities include budgeting, forecasting, strategic planning, tracking the performance of contract service providers, and review/approval of invoices.
10. Manage internal and third-party deviations, customer complaints, and change controls.
11. 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.
12. Participate in the selection, design, configuration, review, and User Acceptance Testing of IRT systems for drug supply management, accountability, and randomization of global clinical studies.
13. Partner with the Quality function to maintain inspection readiness for activities pertaining to labeling and distribution practices. Manage and resolve supply chain related issues such as temperature excursions, shipment related incidents, and other time sensitive issues.
Qualifications and Key Success Factors
1. Bachelors Degree in supply chain, pharmacy, pharmaceutical sciences, engineering, or related field required.
2. 5+ years of pharmaceutical industry experience with a minimum of 3 - 5 years of experience in clinical supplies management.
3. Significant experience in managing global phase I to phase IV clinical studies.
4. Proven track record of effective collaboration and communication skills with internal partners and external providers.
5. Detailed understanding of Good Manufacturing Practices and Good Distribution Practices requirements, QP requirements, EU GDPs, Annex 13, CFR regulations and ICH guidelines governing conduct of clinical studies.
6. Project management skills and expertise in outsourcing and vendor management.
7. 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:
1. 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
2. Bonus program structured to pay on a quarterly basis
3. 401k plan with 100% match up to 6% of employees contribution (Traditional & Roth)
4. Wellness benefits of $200/month to cover incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
5. Unlimited PTO +(2) weeklong shutdowns each year - and a generous extended family leave benefit
6. Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
To round out this world-class total rewards package, we provide base salary compensation in the range of $137k - $146k. Final salary range may be modified commensurate with job level, education, and experience.
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. #J-18808-Ljbffr