Definium Therapeutics

Sales

• Own the end-to-end strategy and execution of sales training and capability development for a novel CNS product
• Shape how the sales organization and adjacent commercial field teams master the science, patient journey, competitive differentiation, and considerations of bringing a novel psychedelic therapy to market
• Design and lead a comprehensive sales training curriculum covering product knowledge, clinical data, disease-state education, competitive landscape, objection handling, account management, and compliant promotional practices
• Build training programs tailored to DT120 ODT, including administration considerations, clinical observation, patient selection, and the evolving regulatory and market access environment
• Partner with Commercial Leadership, Medical Affairs, Market Access, Compliance, and Legal
• Develop and deliver live, virtual, and digital training for onboarding, skill development, launch readiness, and continuous learning, with substantial in-person delivery at the Philadelphia office
• Lead the sales training function and establish processes, tools, and metrics for training effectiveness and field capability
• Create measurement frameworks for knowledge retention, behavioral change, and business impact; refine programs using data and field feedback
• Support sales leadership in coaching frameworks, performance management, and sales-manager development
• Drive excellence, curiosity, and patient-centricity across the commercial organization
• Contribute to commercial readiness planning and advise on field capability needs
• Report to the VP of Sales

Senior Director, Sales Training

Director

• Serve as the senior technical lead and primary point of contact for CDMOs supporting drug product manufacturing, packaging, testing, and release activities
• Lead drug product development and manufacturing strategy across assigned programs, including formulation development, process development, technology transfer, scale-up, process validation, and commercial readiness
• Lead technical oversight of clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, deviations, investigations, and associated technical documentation
• Establish and manage CDMO technical governance, including meeting cadence, performance oversight, escalation pathways, risk management, and issue-resolution processes
• Contribute to cross-functional CMC workstreams with Pharmaceutical Development, Quality, Regulatory CMC, Analytical Development, Supply Chain, Clinical Supply, Program Management, and external manufacturing partners
• Drive identification, assessment, prioritization, and mitigation of process risks, manufacturing challenges, and supply-readiness issues
• Own or co-own process validation strategy, including PPQ strategy, risk assessments, control strategies, CPV plans, and lifecycle process monitoring
• Lead preparation, review, and approval of process validation documentation
• Evaluate manufacturing performance data to identify trends, process capability concerns, technical risks, and continuous improvement opportunities
• Provide senior technical leadership for manufacturing investigations, deviation resolution, CAPA development, change controls, and post-approval manufacturing changes
• Lead secondary packaging development activities for late-stage and commercial-readiness drug product programs
• Oversee packaging design, component selection, labeling configuration inputs, packaging line considerations, packaging validation, and supply-readiness activities
• Support regulatory submissions, agency questions, inspection readiness, and PAI preparation related to drug product manufacturing, process validation, packaging, and CMC content
• Author and/or review CMC sections and technical documentation supporting regulatory submissions, health authority interactions, and lifecycle management
• Manage external technical activities, priorities, budgets, timelines, and deliverables for CDMO partners and consultants
• Provide technical recommendations to senior leadership on manufacturing strategy, CDMO performance, validation readiness, process risks, regulatory readiness, and commercialization decisions
• Mentor and provide technical guidance to junior team members, consultants, and cross-functional partners

Director, Pharmaceutical Development – Drug Product Manufacturing

Compliance

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products
• Provide regulatory advice and solutions to reconcile regulatory comments on draft promotional materials
• Review and approve promotional and medical materials in Definium’s PromoMats system
• Represent the regulatory perspective in live MLR meetings and concept reviews
• Review and approve social media posts
• Liaise with OPDP/APLB (FDA) as the company’s point of contact on advertising and promotional matters
• Manage OPDP/APLB interactions, regulatory inquiries, advisory-comment submissions, and discussions with FDA staff
• Ensure timely and accurate FDA 2253 submissions of US promotional materials
• Ensure prescribing-information changes are reflected in promotional and advertising materials
• Aid development of processes and standards for promotional materials and related activities
• Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, company policy, and PRC processes
• Collaborate with Commercial, Medical Affairs, and Legal from promotional concept through field implementation

Director, Regulatory Affairs – Advertising and Promotions

Analyst

• Assist with gap assessments of existing validation packages against 21 CFR Part 11, EU GMP Annex 11 and Definium SOPs, and help plan and execute remediation
• Help maintain the GxP computerized system inventory, including risk classification, validation status, system ownership and supplier information
• Prepare inspection-ready system summaries and storyboards
• Support the inspection back room by retrieving documents, tracking and fulfilling inspector requests, and preparing system owners and SMEs to present their systems
• Support responses and CAPAs arising from inspection observations and audit findings
• Lead and support validation activities for new and existing GxP computerized systems using a risk-based CSA approach
• Develop and review validation strategies
• Author, review and execute validation deliverables, including validation plans, user and functional requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices and validation summary reports
• Perform validation impact assessments for change requests, including vendor-driven SaaS releases for Veeva and Medidata
• Conduct and document periodic reviews of validated systems, user access and audit trails
• Document and resolve test deviations and incidents
• Assist with data integrity assessments against ALCOA+ principles
• Develop and perform audit trail review procedures and verify record retention and archival controls
• Support decommissioning of ZenQMS following migration to Veeva Vault QMS
• Support qualification and audits of GxP software suppliers and CROs, including review of vendor validation packages, SOC 2 reports and quality agreements
• Help assess sponsor oversight of CRO-hosted clinical systems in line with ICH E6(R3) expectations
• Coordinate with IT and Finance on SOX ITGC evidence for NetSuite and Coupa
• Contribute to the evolution of the validation approach toward CSA
• Contribute to updates of CSV-related SOPs, work instructions and templates

Senior CSV Analyst

• Provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization
• Serve as study lead programmer for assigned clinical trials
• Collaborate with study statisticians, data management, and other study team functions
• Review and ensure quality of Define packages, including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and Define XML
• Review Define packages for integrated datasets to ensure CDISC standards and regulatory submission requirements
• Work with the study lead biostatistician to manage vendor deliverables for quality and timelines
• Perform independent QC validation of vendor deliverables, datasets, and analytical outputs
• Validate analytical outputs produced by internal biostatisticians or statistical programmers
• Produce systematic data reports with Clinical Data Management to support clinical trial data review and cleaning
• Review CRFs and/or Data Transfer Specifications to ensure data collection meets study objectives, requirements, and CDISC standards
• Provide input to Statistical Analysis Plans and TLF shells for Tables, Listings, and Figures
• Perform statistical analyses supporting publications and regulatory correspondence
• Perform other assigned duties

Associate Director, Statistical Programming

Accountant

• Process and review vendor invoices through Coupa, ensuring appropriate coding, supporting documentation, and approvals are obtained
• Assist with vendor setup and maintenance as needed
• Research and resolve invoice discrepancies and vendor inquiries
• Maintain accurate and complete AP records and supporting documentation
• Assist with month-end AP close activities, including reviewing outstanding invoices and accrued expenses
• Prepare and process weekly vendor payments through Coupa in accordance with established payment procedures and internal controls
• Assist with cash activity and bank-related accounting, including recording miscellaneous cash receipts and disbursements
• Prepare and process miscellaneous and routine general ledger journal entries with appropriate supporting documentation
• Assist with bank and cash account reconciliations and investigate reconciling items
• Support month-end and quarter-end close activities
• Perform other accounting, compliance, and internal control-related responsibilities as needed to support the company’s financial reporting and growth objectives
• Report to the Senior Manager, Accounting

Staff Accountant

Recruitment

• Serve as the lead Talent Acquisition partner to Commercial leadership, advising on workforce planning, hiring priorities, recruiting strategy, and talent market dynamics
• Develop launch-ready recruiting plans, talent pipelines, and hiring approaches for critical commercial roles
• Lead full-cycle recruiting across Sales, Market Access, Marketing, Commercial Operations, Training, and other commercial functions
• Develop sourcing strategies and proactive pipelines for specialized, competitive, and field-based commercial talent markets
• Manage complex searches and business-critical hiring initiatives with focus on quality, speed, candidate experience, and business alignment
• Manage, coach, and support Talent Acquisition team members and/or contractors as needed
• Drive scalable recruiting practices, process improvements, systems enhancements, reporting, and cross-functional initiatives
• Use Greenhouse and recruiting analytics to monitor pipeline health, hiring progress, recruiting effectiveness, and executive-level talent insights
• Ensure recruiting practices comply with employment laws, company policies, confidentiality expectations, and ethical standards
• Manage external search firms and recruiting vendors, including partner strategy, selection, performance evaluation, budget awareness, and agency utilization

Director, Talent Acquisition – Commercial

• Provide Quality ownership and leadership for commercial packaging and labeling activities performed by CMOs and CPOs from launch readiness through post-approval lifecycle management
• Serve as Quality relationship owner for packaging and labeling partners, including governance, performance monitoring, quality-event escalation, investigation oversight, CAPA follow-up, and product-impact assessment
• Approve packaging artwork and labeling components for GMP compliance, version control, implementation accuracy, reconciliation, and change control
• Oversee outsourced packaging and labeling readiness and lifecycle management, including artwork implementation, component qualification, line trials, process validation, serialization, reconciliation, and change control
• Review final batch and packaging records and make final batch dispositions/releases to market
• Lead Quality oversight of storage, transportation, returns, destruction, and distribution, including reverse logistics
• Lead commercial launch readiness across 3PL onboarding, distribution-lane qualification, returns processing, traceability-data exchange, mock recall capability, and initial market supply
• Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, transportation lanes, equipment, and supporting systems
• Oversee logistics-related quality events including temperature excursions, shipment damage, loss, theft, diversion, security events, and delivery exceptions
• Serve as Supply Quality lead for recalls, mock recalls, distribution holds, market actions, and returns
• Lead the company’s DSCSA Quality compliance program and incorporate applicable requirements into the Quality Management System
• Establish controls for trading-partner verification, electronic transaction-data exchange, serialization, aggregation, verification, exception management, reconciliation, and record retention
• Provide Quality governance for serialization and traceability platforms
• Lead or oversee suspect and illegitimate product investigations, including quarantine, verification, communication, disposition, corrective action, and regulatory notification
• Monitor regulatory requirements and industry standards and translate changes into procedures, training, partner expectations, and readiness plans
• Own and continuously improve procedures governing packaging quality, distribution quality, product traceability, returns, suspect product, and related quality events
• Manage Quality relationships with commercial supply partners through supplier qualification, audit, approved-supplier, and quality-agreement processes
• Represent Quality in external partner meetings and lead the quality portion of business review meetings
• Lead inspection readiness and provide Quality representation or partner-site support for FDA, state licensing authority, Board of Pharmacy, and other inspections
• Ensure significant quality events are escalated, investigated, assessed for product and compliance impact, and addressed through CAPA
• Track, trend, and report quality and compliance indicators to senior leadership and Management Review
• Establish functional strategy, priorities, performance indicators, and resource plans aligned with launch and ongoing commercial supply objectives
• Influence internal stakeholders and external partners through governance, risk-based decision-making, and escalation