Definium Therapeutics

• 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!

• 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

• 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

• 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

• 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

• 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

• 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

Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals. The Senior Clinical Trial Associate, Clinical Operations, plays a key role in administratively supporting the planning, execution, and management of clinical trials within the organization. The Senior CTA works closely with the clinical operations team to ensure the successful implementation of clinical trials, adherence to regulatory guidelines, and the collection of high-quality data. The Senior Clinical Trial Associate is a senior administrative role and will provide mentorship and guidance to the junior Clinical Trial Assistant role. The Senior Clinical Trial Associate will also support the development and review of Clinical Operations Department Administrative SOPs, Plans and System build. In addition, the Senior CTA will support the design and structure of the Admin framework and implementation of new processes or improvements to current process create processes not currently in place. The Senior Clinical Trial Associate may take ownership and manage sub-projects within the trial (ex: DEA Schedule I oversight at the site and central trial levels) and work closely with key consultants to drive the successful implementation and oversight of sub-projects. They will be the point of contact for all administrative needs for third-party vendors used within a trial and may have some oversight on monthly financial reporting and tracking. PRINCIPAL RESPONSIBILITIES: - Establishes, performs quality control, maintains, and archives the Trial Master File (i.e., electronic folder set-up, filing, tracking, archiving) in compliance with DIA Reference Model, SOPs, ICH and GCPs. Ensures prper naming conventions are followed - Assist with study start-up, including development of budgets, contracts, financial disclosure statements, and grant payments - Coordinates distribution of documents and supplies/dosing room materials to sites and vendors/CRO as necessary - Develops and maintains spreadsheets and other documents to track critical study milestones Tracks and reports on project or study information regarding subject and site status, metrics, lab sample shipments and discrepancies, and other parameters as appropriate - Track and manage study-related documentation, including regulatory submissions, ethics committee approvals, and site contracts - Prepares or assists with the preparation and review of study-related materials as it pertains to CTA processes (e.g., study reference manual, clinical trial material requests, and Investigator Site File) - Organizes study information on the shared file drives - Maintain trial Storyboard - Lead and manage project-based assignments in support of clinical trials (ex: creating process documents and trackers; managing Schedule I activities) - Design and create process/guidance documents for the Clinical Trial Assistant role-based tasks and responsibilities - Assist in the writing and review of SOPs for the Clinical Operations department and support systems build out (ex: CTMS, eTMF, etc) - Performs assigned administrative activities in a timely manner in support of clinical trials from design to completion - Sets up and attends meetings, takes thorough meeting notes, and updates and distributes meeting minutes - Organizes and helps plan meetings. May interact with meeting planners and travel agents - Coordinates the distribution of communications to all sites (e.g., questionnaires, newsletters, mass mailings, IND safety reports, Investigator’s Brochures, etc.) - Assists the Clinical Operations Trial Lead with tracking and processing of vendor or site invoices and ensures accurate accrual records are kept for the trials. Raise PO requests and request tax documents from vendors and consultants - Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance - Provides general administrative support to the clinical team as assigned - Processes forms, requests for information by the team, and requests to obtain information from vendors and investigative sites - Provide guidance, mentorship, and daily oversight for more junior Clinical Trial Assistants assigned to specific clinical studies - Responsible for obtaining license agreements for all ClinRo/PROs/scales and updating license holders as required per contract EDUCATION AND EXPERIENCE REQUIREMENTS: - Bachelor’s degree or equivalent combination of education/experience in science or health-related field - Prior experience in clinical research, preferably as a Senior Clinical Trial Assistant or with at least 2 years in the Clinical Trial Assistant role - Experience in Psychiatry and addiction medicine preferred - Willingness and ability to travel up to 5-10% of the time, defined by business needs - Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA - Prior experience in development of tools and other tracking documents that support clinical research - Prior experience with supporting study startup activities - Strong communication skills with outside vendors and contractors - Willing to maintain flexible work hours as needed and available during core business hours during critical periods of a trial - Strong working knowledge of MS Project or Smartsheet and developing Gantt charts - Advance knowledge of MS Excel/Google Sheets - Excellent oral, written, and communication skills required - Problem-solving and strategic planning skills - Excited by innovative ideas in clinical research space; has a voice and provides meaningful contributions in meetings/calls - Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment - Engaging, empathetic and dynamic personality; up for challenges and determined to find solutions - This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment The starting base pay range for this position is $91,943.00 - $112,330.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including: - 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!