Definium Therapeutics

• Monitors state legislation and regulatory activities, updating and advising on relevant policy proposals and actions, and working with the cross-functional teams to analyze potential impacts to Definium • Develop and execute strategies to shape state policy that delivers on enterprise priorities. This includes developing/executing strategic initiatives and policy positions, drafting written comments, analysis of complex health care policies, direct lobbying, engagement of third-party groups and coalitions • Develop both a proactive and reactive policy agenda to create new frameworks to support Definium’s pipeline • Assess public policy environment, determine where legislative and regulatory action is advisable and where it is not, and make recommendations on Definium action • Demonstrate and maintain strong working relationships with key state and regional stakeholders that may develop health care policies that could impact Definium • Build stakeholder partnerships and advocacy coalitions that advance mental health awareness, patient access, and policy priorities while strengthening Definium's leadership across the healthcare ecosystem • Develop close working relationships with key internal cross functions stakeholders to leverage advocacy strategies. Engage with these key business stakeholders and develop keen understanding of commercial strategies to ensure public policy strategies support Definium’s commercial and regulatory objectives

• Serve as the technical contact for CDMOs supporting drug product manufacturing and release activities • Lead oversight of drug product development activities, including process development, tech transfer, scale-up, and validation • Provide technical leadership for clinical and commercial drug product manufacturing campaigns, including review and approval of batch records, campaign plans, protocols, reports, and investigations as applicable • Partner with CDMOs to identify, assess, and mitigate process risks and manufacturing challenges, ensuring timely resolution of technical issues • Contribute to the development of process validation strategies for drug product manufacturing in collaboration with internal and external stakeholders • Oversee preparation, review, and approval of process validation documentation, including process performance qualification (PPQ) protocols/reports, risk assessments, control strategies, and continued process verification plans • Evaluate manufacturing performance data to identify trends, process capability concerns, and opportunities for continuous improvement • Lead secondary packaging development activities for a drug product in late-stage development • Support development of packaging design, component selection, labeling configuration inputs, packaging line considerations, and secondary packaging validation activities with external partners and internal stakeholders

• Develop and implement stakeholder engagement strategies for relevant external audiences • Develop and execute communication plans that clearly convey the real-world value of the company’s products • Cultivate and maintain relationships with key health care decision-makers and influencers, including U.S. payers, academic institutions, key opinion leaders, health system providers, and policy stakeholders • Contribute to the development of integrated evidence generation plans by identifying and collecting field-generated real-world data insights to fulfill evidence gaps • Partner closely with internal functions—including Clinical Development, Clinical Operations, Policy, Commercial, Market Access, and Medical Affairs—to develop and/or support programs that address broad product access and demand challenges • Partner with health system providers, practices, and site of care delivery teams to support site readiness and operationalization of patient care sites, including facilitating access to healthcare economic data, reimbursement pathways, practice economics analyses, and patient services resources that enable successful practice adaption • Contribute to account planning with cross-functional field-based teams, identifying areas where value and healthcare economic information can be collected or utilized to support patient access • Support and/or deliver the presentation of disease related information, and healthcare economic information to health care decision makers • Represent the company at key national and international conferences

• 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

• 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

• 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

• 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

• 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

• 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

Role Description The Senior Director, Late-Stage Clinical Strategy will be responsible for the end‑to‑end strategy development, design, and execution of Expanded Access Programs and Late-Stage studies across Definium's portfolio. This leader will provide support to ensure programs are scientifically sound, operationally feasible, regulator‑ready, and aligned with the integrated asset strategy, including lifecycle management, real‑world evidence generation, and post‑approval commitments. This role requires both strategic leadership and hands‑on execution, with the ability to operate effectively in a lean, fast‑moving organization. Responsibilities - Strategic Leadership - Lead aspects of the global strategy for Expanded Access Programs and Late-Stage development, aligned with asset lifecycle objectives, patient access goals, and regulatory expectations. - Partner with the Executive Director Late-Stage Clinical Strategy, Clinical Development, HEOR, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead, and Program Leadership to ensure EAP and Late-Stage clinical activities are fully integrated into the overall asset strategy and Target Product Profile (TPP). - Expanded Access Program Execution - Assist the development and implementation of Expanded Access Programs, including protocol development, eligibility criteria, safety oversight, and operational execution. - Collaborate with cross‑functional planning team to ensure EAPs are compliant, scalable, ethically sound, and aligned with regulatory guidance. - Provide consultation to benefit–risk assessment, safety monitoring, and ongoing program evaluation. - Late-Stage Strategy & Execution - Support the development of potential phase 4 objectives and lead the design, plan, and execution of potential phase 4 study(ies), ensuring potential phase 4 program objectives, including real‑world evidence generation, long‑term safety, effectiveness, and differentiation in the treatment landscape. - Lead the design, planning, and execution of late stage and prepare for the possibility of Phase 4 studies, including protocol development, data collection strategies, and interpretation of outcomes. - Ensure late stage and any potential Phase 4 program design address regulatory commitments, payer needs, and scientific gaps. - Regulatory & Scientific Leadership - Collaborate in the preparation and review of clinical content for regulatory submissions and interactions as applicable. - Provide clinical input into Investigator Brochures, clinical study reports, in collaboration with Regulatory Affairs. - Cross‑Functional & External Engagement - Work collaboratively with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Project Management to ensure high‑quality execution. - Establish and maintain relationships with key investigators, advisors, and external experts to support EAP and late stage/potentially Phase 4 objectives. - Provide clinical leadership within matrix teams, modeling accountability, collaboration, and scientific rigor. Qualifications - Doctoral degree required (MD, PhD, PharmD, PsyD) - 8+ years of clinical development experience in the pharmaceutical or biotechnology industry - Demonstrated experience leading late‑stage, post‑approval, Expanded Access, and/or later stage programs - CNS development experience (psychiatry or neurology) strongly preferred - Experience in small‑molecule development preferred Requirements - Working knowledge of clinical development, regulatory pathways, and lifecycle management - Proven ability to translate strategy into execution in resource‑constrained environments - Track record of effective cross‑functional leadership and external stakeholder engagement - Ability to operate with diplomacy, influence without authority, and command credibility with senior leaders and external experts - Excellent verbal and written communication skills - Self‑motivated, adaptable, and comfortable balancing strategic thinking with hands‑on contribution Benefits - 100% paid health benefits including Medical, Dental and Vision for you and your dependents - 401(k) program with company match and vesting after the turn of the first month after your start date - Flexible time off - Generous parental leave and some fun fringe perks!