Definium Therapeutics

Cloud Engineer

• Design deploy maintain optimize and automate scalable secure and resilient cloud infrastructure and solutions across Azure GCP and AWS
• Manage backup and disaster recovery strategies across cloud platforms
• Implement and maintain robust cloud security controls aligned with industry standards CIS NIST and ISO 27001
• Implement and maintain Infrastructure as Code cloud automation and CI CD driven deployments
• Support cloud automation initiatives including infrastructure automation integrations operational workflows and platform stability improvements
• Enable AI and intelligent automation use cases in alignment with established governance and security standards
• Troubleshoot cloud platform issues support incident resolution and maintain technical documentation and runbooks
• Help define and enforce cloud governance standards including management groups subscriptions Azure Policy RBAC naming conventions tagging and cost controls
• Implement automation in ServiceDesk identity and other enterprise platforms to drive consistent efficient and rapid experiences
• Engage with IT and functional stakeholders to define business processes align them to appropriate technology solutions and represent Definium technology interests on initiatives with significant technology impact
• Translate functional and technical requirements into solution architecture and provide build and deployment guidance to software developers
• Design scalable supportable systems by selecting technology stacks that can be supported by a broad ecosystem of providers and technically skilled Definium staff
• Identify and evaluate technology partners and maintain relationships with strategic vendors to stay informed of evolving capabilities and risks
• Stay current on leading and emerging technologies and evaluate fit against financial security and operational requirements
• Cross train and mentor junior engineers

Senior Cloud Engineer

Affiliate Manager

• Act as the primary IT point of contact for Commercial and Medical Affairs leadership, developing strong, trust‑based partnerships
• Understand the Commercial and Medical Affairs strategy, business goals, and operational challenges, aligning business objectives to clear, prioritized IT initiatives and requirements
• Support systems and new product introduction by providing technical expertise, system administration, problem solving, and strategies for risk mitigation
• Support the overall governance and lifecycle management of commercial and Medical Affairs systems and platforms. (e.g., Veeva Vault CRM, Open Data, Link, Approved Email)
• Lead requirements gathering, documentation, and testing for commercial and Medical Affairs platforms. Ensure configuration, enhancement, and expansion of the systems aligns with broader organizational data standards, information security practices, and regulatory needs
• Work closely with IT and Legal to ensure data protection controls such as segmentation and access boundaries are designed, implemented, and consistently enforced in alignment with regulatory requirement
• Ensure alignment between business demand and IT capacity and prioritization
• Provide oversight and system administration across SaaS platforms supporting Commercial operations and Medical Affairs. (e.g., CRM, field enablement, analytics, content management)
• Ensure solutions are scalable, user‑centric, and aligned with enterprise architecture standards
• Monitor delivery risks, dependencies, and change impacts; escalate as appropriate Serve as a clear communicator between technical and non‑technical stakeholders
• Drive change management, user adoption, and ongoing optimization of deployed solutions.

IT System Business Partner – Commercial and Medical

Marketing

• Develop and execute medical marketing initiatives that support the scientific positioning and successful commercialization of DT120
• Lead KOL engagement strategy, including identification, segmentation, relationship development, and ongoing engagement planning
• Manage advisory board planning and execution, including objectives, attendee selection, content development, logistics, and insight capture
• Support medical congress strategy and execution, including sponsorships, exhibits, symposia, scientific communications, and stakeholder engagement activities
• Partner with Medical Affairs, Clinical Development, Commercial, and Regulatory teams to align scientific engagement activities with broader organizational objectives
• Direct external agency partners and vendors supporting congresses, advisory boards, speaker programs, and scientific communications initiatives
• Gather and synthesize insights from KOL interactions, advisory boards, congresses, and market intelligence to inform brand and evidence-generation strategies
• Support development of scientific communication materials and engagement initiatives that strengthen awareness, credibility, and launch readiness

Associate Director, Medical Marketing

Digital Marketing

• Develop and execute patient / consumer marketing strategies and annual brand plans to support the successful launch and commercialization of DT120
• Manage key patient marketing initiatives across the product lifecycle, including pre-launch planning, audience segmentation, campaign execution, performance measurement, and optimization
• Drive digital patient engagement strategy, including branded and unbranded web experiences, CRM, social media, search, and other non-personal promotional initiatives
• Oversee the promotional review process (MLR/PRC) to ensure all patient-facing marketing materials are compliant with regulatory requirements
• Partner with Medical Affairs, Market Access, Patient Services, Sales, and cross-functional commercial teams to align patient engagement strategies with broader business objectives
• Direct external agency partners across creative, digital, media, analytics, and market research to deliver high-impact, ROI-driven initiatives within budget
• Translate patient, caregiver, and market insights into actionable strategies that strengthen engagement, differentiation, and launch readiness
• Support patient advocacy, congress, and community engagement initiatives that enhance awareness, education, and brand presence

Associate Director, Patient & Digital Marketing

Human Resources

• Manage new hire onboarding by sending welcome emails, adding hires to the HRIS, assigning onboarding tasks and forms, coordinating first-week orientation, and maintaining the new hire tracker
• Support Talent Acquisition processes by partnering with recruiters to post jobs, confirm position details, format job descriptions, and audit descriptions for compliance and consistency
• Assist with offer letters and ensure all details are accurate and consistent
• Manage external job postings and the pre-employment processes by initiating and monitoring background checks, reviewing results, and tracking pre-boarding requirements and activities
• Deliver a positive, consistent candidate experience at every touchpoint
• Support departmental administrative needs, including travel, expense reporting, meeting coordination (individual and group meetings), swag inventory, documentation requests, and electronic filing
• Support HR budget processes by setting up vendors, creating purchase orders, tracking expenses, and coordinating with Finance to ensure timely invoice processing and accurate reporting
• Support HR related trainings and workshops, such as education sessions for managers, leadership coffee chats, and new hire sessions, by coordinating logistics, preparing materials, tracking attendance, administering surveys, enabling remote participation, and assisting with event planning for conferences and job fairs

Senior Human Resources Coordinator

Engineer

• Provide operational support for remote staff. This will include hardware and software issues
• Create, update, triage, and close support tickets in the Definium ITSM to ensure a thorough documentation of requests and incidents, end-user communication, root cause analysis and resolution
• IT lead for all new and departing employee responsibilities. Ensure compliance with all on-boarding and off-boarding policies and procedures
• Coordinate the hardware lifecycle for remote employees from procurement, configuration, collection, and retirement
• Provide primary/secondary system administration to IT systems
• Work closely with IT MSPs and professional service providers
• Assist in identifying, evaluating, justifying, and deploying, new products, technologies, systems, services, and workflows
• Independently perform actions under departmental change control procedures with minimal oversight or assistance
• Ensure compliance for technology projects and processes including Sarbanes Oxley (SOX), 21 CFR Part 11, cGxP, and GDPR
• Author and review standard operating procedures and knowledge-based articles for the maintenance and operation of software applications
• Ensure that best practices for the service and support of technology products are documented and followed
• Stay up to date on industry trends and best practices

End User Computing Engineer

Director

• Provide statistical input to the creation of clinical development plan for the assigned compound(s)
• Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objective, endpoints and sample size
• Play as an integral part of a protocol development team by authoring statistical methods section and reviewing the protocol throughout
• Ensure the accuracy of randomization algorithm and contribute to eCRF design to ensure data collection’s alignment with study objectives
• Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
• Hold the primary responsibility of working with statistical vendors to implement the SAP and deliver study results with quality and speed
• Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
• Conduct data analyses as needed by using own SAS programs in collaboration with Statistical Program group for validation
• Contribute to the development of Biometrics’ SOPs

Director, Biostatistics

Product Manager

• Support development and execution of HCP marketing strategy aligned with brand objectives and commercial priorities
• Contribute to brand planning, launch readiness, and tactical planning processes
• Help shape HCP promotional strategy and messaging based on customer insights, market dynamics, and competitive intelligence
• Translate complex scientific and clinical data into clear, compelling HCP-focused promotional narratives
• Identify opportunities to optimize HCP engagement across customer touchpoints and channels
• Lead development and execution of HCP promotional initiatives to support brand performance and launch objectives establishing scalable commercial processes and operating discipline within a growing organization
• Own assigned promotional workstreams from strategy through execution, measurement, and optimization ensuring flawless delivery while balancing speed, quality and compliance
• Develop tactical plans aligned with approved strategic direction, including timelines, budgets, and execution plans
• Serve as primary day-to-day marketing lead with the AOR across HCP promotional initiatives
• Provide clear strategic direction, feedback, and decision-making to agency partners to ensure high-quality deliverables
• Partner closely with Medical, Regulatory, Legal, Commercial Operations, Sales, Market Access, Analytics, and Market Research teams to drive aligned execution
• Lead promotional materials through review and approval processes in partnership with cross-functional stakeholders
• Leverage market research, analytics, field insights, and competitive intelligence to inform decision-making
• Monitor performance of promotional initiatives and identify opportunities for optimization
• Manage HCP marketing budgets across assigned initiatives tracking timelines, milestones, deliverables, and agency spend

Senior Product Manager, HCP Marketing

Sales

• Build and Lead the Sales Field Team: Recruit, develop, mentor, and retain a high-caliber national sales team. Provide ongoing coaching, performance management, and leadership to ensure the team meets or exceeds sales targets
• Oversee Sales Training: Design, implement, and continuously improve comprehensive sales training programs to equip the field team with deep product knowledge, selling skills, and expertise in the neuroscience/CNS landscape
• Drive Product Launch: Lead the execution of sales strategies and tactical plans for DT120, contributing to rapid market adoption and revenue growth
• Cross-Functional Coordination: Partner closely with the commercial operations team and other functions to ensure territory mapping, deployment scenarios, and resource allocation are adequate and optimized. Facilitate effective collaboration across commercial teams (e.g., with marketing, medical affairs, and market access) to support integrated pull-through initiatives
• REMS and Specialty Expertise: Apply experience with Risk Evaluation and Mitigation Strategy (REMS) programs or other complex distribution models to guide compliant and effective sales execution
• Foster Sales Culture: Cultivate a collaborative, inclusive, and high-integrity sales culture that emphasizes ethical practices, accountability, teamwork, and a patient-centric mindset
• Performance Management & Insights: Establish clear KPIs, monitor field performance, and provide regular feedback and adjustments. Share field insights with cross-functional partners to refine commercial strategies
• Compliance: Ensure all sales activities adhere to the highest ethical standards, regulatory requirements, and company policies

Vice President, Sales – Neuroscience

• Develop annual marketing plans, brand strategies, and value propositions for DT120
• Manage the entire product lifecycle from pre-launch to post-launch, including market assessment, segmentation, and differentiation, execution, measurement, and optimization
• Oversee the promotional review process (MLR/PRC) to ensure all marketing materials, including digital and print, are compliant
• Partner with R&D, Medical Affairs, Market Access, and Sales teams to shape evidentiary needs and support commercial objectives
• Direct external advertising/media/market research agencies and manage marketing budgets to ensure high-ROI initiatives
• Drive digital strategy, including Veeva systems, social media, and web initiatives to engage Healthcare Professionals (HCPs) and patients
• Identify and build relationships with Key Opinion Leaders (KOLs) to support scientific exchange and brand positioning. Drive congress and advisory board planning and execution

Senior Director, Marketing

Communications

• Lead the development and execution of integrated communications programs that elevate awareness of product differentiation and their potential to address unmet medical needs in support of company goals.
• Serve as the communications lead for our commercial product teams and participate in regular team planning meetings
• Establish collaborative working relationships with R&D, medical affairs, regulatory, government affairs, and brand teams to develop communications plans that shape differentiated messaging across audiences that redefine a new era in psychedelics and psychiatric care
• Direct multiplatform, integrated PESO (paid, earned, social, owned) communications campaigns
• Develop and deploy media relations plans; work with and maintain relationships with journalists
• Reflecting the increasingly social/digital way that key audiences get their information, a predominant focus will be on the strategic design and implementation of sophisticated, highly targeted social/digital efforts designed to educate, raise awareness, and shape the market ahead of potential launch
• Support KPI and measurement framework development, and provide regular readouts/metrics tracking with recommendations for optimization
• Lead reputation and issues preparedness planning, including scenario planning, Q&A development, and leadership briefings
• Partner with Medical Affairs and Clinical Development to ensure accurate translation of complex scientific information into clear, compliant, targeted communications
• Develop engaging employee communications that inform, align, and excite colleagues about our pipeline and products
• Oversee materials through Definium’s internal review systems, ensuring all content meets regulatory, legal, and business standards
• Represent function on integrated teams and proactively contribute to decision-making with business partners
• Manage PR agency, ensuring alignment between internal decisions and agency work product, while ensuring delivery of high-quality, strategically aligned work on time and on budget
• Help ensure Definium remains on the cutting edge by incorporating the latest technology (e.g., AI) and data into planning and measurement efforts

Director, Product Communications

• Leads the design, implementation and management of HEOR studies from concept development through publication. HEOR studies may include, but are not limited to, prospective research studies, patient interviews, and payer-focused tools (i.e. dossier, external facing assets)
• Help identify evidence gaps and needs from regulatory, reimbursement and patient perspectives, resolve these challenges and translate strategic objectives into the HEOR / Real-World Evidence (RWE) plan
• Directs the generation of necessary evidence to demonstrate product differentiation and values, and / or to support clinical development, regulatory needs through RWE and epidemiology studies in a timely and strategic manner
• Work closely with other functions in cultivating strong internal partnerships, including research and development strategy, epidemiology, regulatory, policy, market access and medical affairs on the development on programs that support broad access and value
• Support proactive engagement with payer advisors and KOL stakeholders including generating strategic insights on endpoints, PCOA, and trial design. Identify relevant PCOA endpoints and provide input to the clinical development plan
• Psychometric validation of patient-reported outcomes and instruments
• Help develop protocols for RWE (prospective and retrospective) analyses, PROs, surveys/patient interviews and provide innovative solutions on RWE for use as a synthetic/historical or concurrent control, including expertise on methodological considerations to account for confounding, missing variable, temporal or other biases and/or methodological challenges
• Experience in evidence synthesis (in conducting systematic literature review, indirect treatment comparisons, gap analyses for effectiveness, meta-analysis)
• Collaborate with Publications and other functions on development of real-world evidence publications for congresses and peer-reviewed journals
• Provide project and vendor management support, including request for proposal, statement of work, vendor selection, legal & compliance issues, and budget tracking
• Develop and maintain strong, collaborative relationships with the broader Definium organization and with external experts
• Help support and manage deliverables such as value dossiers, reimbursement dossiers, reimbursement landscape analyses, consultant driven research projects
• Ensure that deliverables are accomplished on time and within budget

Director, HEOR

• Serve as a responsible member and clinical science representative on global development teams
• Collaborate with cross‑functional partners to provide clinical development expertise in support of study execution
• Provide therapy‑area medical and scientific expertise in the evaluation and presentation of clinical trial data
• Write and edit clinical protocols, clinical study reports, manuscripts, and other study‑related documents
• Support the quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/ISE, clinical expert reports) in partnership with Regulatory Affairs and Project Management
• Review and monitor patient‑level and study‑level data, including participation in blinded data review and use of data science approaches as applicable
• Collaborate with statisticians and programmers on statistical analysis plans and interpretation of clinical data
• Work with Medical Writing to support abstracts, manuscripts, and presentations for external scientific meetings
• Act as the clinical science lead to CROs and external vendors, with appropriate oversight from senior leadership
• Contribute to a culture of innovation, collaboration, and continuous improvement
• Perform additional responsibilities as assigned by leadership

Associate Director, Clinical Development – MDD

Operations

• In collaboration with Medical Affairs leadership, develop, operationalize, and continuously refine the Medical Affairs strategy, helping to translate strategic objectives into actionable project plans, KPIs and timelines
• Oversee and ensure the quality of the departmental strategic planning processes, including operations tasks, and other activities related to pipeline compounds
• Leads organization, updating and communication of strategic plans to internal and external stakeholders
• Foster strong partnerships with internal teams such as Clinical Development, HEOR, Commercial teams, & finance to ensure alignment and efficiency in medical activities
• Develop, maintain, and update Medical Affairs SOPs and quality documentation to support compliant, efficient, and consistent operations
• Work in close collaboration with Compliance, Regulatory, and Legal counterparts to develop materials that align with regulatory requirements and industry best practices
• Implement and refine operational governance frameworks for scientific review and medical communication standards
• Ensure material development for internal and external use is aligned with organizational goals and priorities and meets compliance, regulatory, and legal requirements
• Establish and oversee project management frameworks for all MA initiatives, including medical launches, clinical collaborations, evidence-generation programs, and scientific communication outputs
• Monitor timelines, risks, and deliverables; provide transparent reporting to leadership on progress and resource needs
• Coordinates cross-functional project teams to ensure timely execution and integration of medical insights into decision-making
• Maintenance of program budget trackers and financial forecast for Medical Affairs programs
• Implement and optimize systems and tools to enhance productivity and data management
• Develop and track key performance indicators (KPIs) to measure the effectiveness Medical Affairs operations
• Collaborate with IT to implement and optimize technology solutions for medical operations
• Serve as a liaison between Global Medical Affairs and other departments to facilitate smooth operations and communication across regions

Senior Director, Medical Affairs Operations – Strategy

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production
• Provide oversight of CROs, vendors, and internal teams to maintain quality standards and performance metrics
• Ensure CDM documentation, SOPs, and processes support high data quality, integrity, and regulatory compliance with FDA, GCP, ICH, and GCDMP requirements
• Partner within Biometrics and Data Science as well as cross-functionally on data management issues and alignment
• Recruit, develop, motivate, and provide leadership to CDM staff and consultants
• Support resource planning, budget forecasting, timelines, and issue resolution for ongoing clinical trials
• Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and quality
• Escalate strategic, budgetary, or cross-functional issues when broader leadership input is required
• Ability to meet deadlines, prioritize workload, and handle multiple priorities simultaneously
• Experience with data visualization tools (e.g., Elluminate) (preferred)
• Must maintain an inspection-ready environment and support regulatory readiness
• Willingness to travel as needed