{"id":1549535,"url":"https://alion.io/job/ptcbio-associate-director-clinical-supplies","title":"Associate Director, Clinical Supplies","company":{"id":2004095,"name":"PTC Therapeutics","domain":"ptcbio.com","url":"https://alion.io/company/ptcbio","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Finance","role_family":"Finance","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Warren, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":165500,"max":194700,"currency":"USD","period":"year","gross":null,"usd_annual":194700},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-22T00:00:00Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-10-18T16:55:08Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":28},"description":"PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.\nAt PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.\nVisit our website to learn more about our company and culture!\nSite: www.ptcbio.com\nJob Description Summary:\nThe Associate Director, Clinical Supplies is responsible for operational oversight of the forecasting, planning, packaging, labeling, distribution, reconciliation, and destruction of Clinical Trial Materials (CTM) and any additional study medication/products to support PTC global clinical trials and serves as the Lead Clinical Supplies team member.He/she is responsible for oversight and management of PTC clinical supply distribution and Contract Manufacturing Organizations (CMOs) and distribution providers.\nThe incumbent works closely and collaborates with PTC internal departments, third party vendors (including but not limited to: Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and shipping agents) and clinical study site representatives to ensure the availability of CTM at study sites globally.\nThe Associate Director, Clinical Supplies, ensures operations and activities are executed in accordance with all internal Standard Operating Procedures (SOPs) and in accordance with all local, county, state, and federal laws and regulations including current Good Manufacturing Practice (cGMP) regulations, GCP, FDA and International Conference on Harmonisation (ICH) guidelines.\nThe incumbent works cross-functionally with internal departments and external resources on Clinical Supply related issues.\n.\nJob Description:\nESSENTIAL FUNCTIONS\nPrimary duties/responsibilities:\nClinical Supplies Planning\nAbility to read, interpret, and provide feedback on clinical protocols.\nEngages in cross-functional planning at the program level, providing leadership on clinical supplies matters to ensure alignment across teams.\nAbility to use the Protocol along with projected and real time data to create and manage a forecast demand for a given clinical trial and at the program level.\nLeading the design of the packaging for the Clinical Trial.\nDevelop and manage the label text and proof generation process including the development of the Master English Label Text and working with a vendor to provide translations and regulatory information for the countries participating in the clinical trial.\nEnsure primary and/or secondary packaging and labeling designs are maintained in accordance with product stability, clinical study dosing/dispensing, and local regulatory requirements.\nSchedules and implements labeling, packaging and quality release operations with CMOs and internally with the Quality department to ensure continuous clinical supply.\nAssist in the development of the clinical trial Pharmacy Manual.\nPrepare CTM-related information presented at investigator meetings and ensure it is accurate, clear and compliant.\nEnsures consistency across the program for presentation of investigational product, as applicable.\nDefine, test, and approve Interactive Voice Response/Interactive Web Resources (IVR/IWR) system specifications and user requirements for tracking inventory, allocation, distribution, use by-date management, destruction activities, reports, and alerts.\nAccountable for ensuring the CTM-related information presented at investigator meetings is accurate, clear, and compliant.\nFinancial Management\nIdentify vendors/resources, create Request for Quote (RFQ), and lead negotiation of pricing and processing of the legal documents required to engage the vendor’s services.\nCreate, maintain, and monitor the clinical program budget.\nWork with Finance if changes are required to the budget.\nWork with Procurement to generate purchase orders/requisitions.\nResponsible for the review of monthly invoices from vendors and aid accounts payable when an invoice is received.\nProject Management\nManage the development of timelines for production release and distribution of clinical trial material.\nAbility to influence other departments and vendors without direct management to ensure the clinical trial timeline is achieved.\nRecognize potential study risks in advance and provide risk mitigation options.\nMaintain “audit-ready” state ensuring investigational medicinal product (IMP) regulatory documentation is ALCOA+ and archived in the appropriate document repository.\nProvide a monthly status report on assigned clinical trials to upper management.\nCoordinate with internal and external stakeholders to achieve the clinical trial timeline.\nParticipates in clinical study team meetings; advises the study team on the optimal supply strategy, aligns with study details and collaborates in achieving study objectives by providing supporting information to the study teams as required and communicates and discusses clinical trial supply timelines, cost and risk limitations.\nEnsures receipt, documentation and resolution of product complaints and incidents from investigator sites.\nInventory Management\nMonitor IMP inventory levels at regular intervals.\nFor expired supply; determine if the use-by date should be extended or request destruction where applicable. \nCompare IRT inventory periodically to vendor inventory to ensure accuracy, if applicable.\nCompare current inventory to projected consumption rate to assess the health of the IMP and to determine if/when additional campaigns will be required.\nWork with vendors regarding the return, accountability, and destruction of IMP.\nResponsible for adjudication of temperature excursions that occur at the Contract Distribution and Manufacturing Organization (CDMO), clinical site facilities, and while IMP is in transit to the clinical site.\nDistribution\nDefine finished good IMP supply chain utilizing Distrbution Depots where required.\nMonitor to ensure IMP shipments are being dispatched and received in a timely manner.\nEnsure both clinical sites and Depots are performing IRT transactions where applicable.\nSchedule and monitor QP release within the UK and EU and work with QP to ensure the Product Specification File (PSF) is up to date and contains all the necessary documentation required to release the IMP.\nProcess Improvement\nIdentifies and drives process improvement initiatives, taking ownership of implementation and outcomes.\nPeople\nManages workload allocation for junior staff supporting assigned clinical supply activities across protocols and programs.\nActs as a coach and mentor to staff members across the team.\nCan participate in interviews and hiring staff.\nLeads by example to encourage others to prioritize personal and professional development.\nundefinedPerform other tasks and assignments as needed and specified by management.undefined\nKNOWLEDGE/SKILLS/ABILITIES REQUIRED\n* Minimum level of education and years of relevant work experience.\nBachelor’s degree and a minimum of 8 years of relevant clinical drug supplies experience in a pharmaceutical, biotechnology, contract research organization (CRO), university medical center or related environment or Master’s degree with 6 years of relevant clinical drug supplies experience.\n* Special knowledge or skills needed and/or licenses or certificates required.\nHands-on experience supporting and understanding GMP, Good Clinical Practice (GCP), and ICH guidelines as related to CTM labeling, packaging and distribution operations and the overall drug development process.\nHands-on experience supporting clinical supply chain for clinical trials.\nIRT (IVRS and/or IWRS) experience\nProficiency with Microsoft Office (including MS Project).\nExcellent verbal and written communication and skills.\nAbility to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.\nAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. \nExcellent planning, organization and time management skills including the ability to support and prioritize multiple projects.\nExperience shipping clinical supplies to domestic or international locations including knowledge of the shipping documentation required for both.\n* Travel requirements\n10-20%\nExpected Base Salary Range: $165,500 - $194,700. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.\nIn addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.\nEEO Statement:\nPTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.\nClick here to return to the careers page","description_format":"text","description_chars":9469,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development","Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T23:49:22Z"}],"visa":[],"liveness":{"score":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.68,"p_room":0.45,"age_days":28,"expected_fill_days":15,"reasons":["conf:36","win:tail"],"computed_at":"2026-10-20T05:45:00Z"},"pay":{"stated_usd_annual":194700,"is_top_pay":false},"html_url":"https://alion.io/job/ptcbio-associate-director-clinical-supplies","json_url":"https://alion.io/job/ptcbio-associate-director-clinical-supplies.json","meta":{"generated_at":"2026-10-20T05:55:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":6461,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2004095},"rest":"https://alion.io/mcp/rest/get_company?id=2004095"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fptcbio-associate-director-clinical-supplies"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fptcbio-associate-director-clinical-supplies"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fptcbio-associate-director-clinical-supplies"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/ptcbio-associate-director-clinical-supplies\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fptcbio-associate-director-clinical-supplies"}]}