Disc Medicine

QA Engineer

• Provide quality partnership and oversight of Disc Medicine’s Biologics manufacturing, testing, and disposition of products.
• Support ongoing technology transfer of drug product and device manufacturing processes.
• Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations.
• Collaborate with cross-functional teams to draft, review, and verify documents to Health Authority CMC submissions.
• Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products.
• Partner closely with internal stakeholders to ensure program alignment and timely delivery of quality milestones.
• Identify and escalate quality risks while driving effective, compliant resolutions.

Director, GMP Quality Assurance

Manager

• Partner with Disc cross-functional team members on overall account and territory strategy to maximize internal/external customer knowledge on payer policy and processes.
• Support patients pull-through with appropriate access education.
• Act as a subject matter expert on the US market access landscape. This includes payer policies, prior authorization requirements, denials, appeals, peer to peer and other education required to navigate access
• Create short-term & long-term strategic account plans focused on increasing customer knowledge and access confidence for key accounts
• Collaborate with Disc Patient Services and Orsini Specialty Pharmacy on individual case management needs related to HCP education and patient pull-through
• Assess key metrics including time to therapy to support ongoing innovation and collaborations to meet or exceed performance objectives.

Regional Access Manager

Operations

• Reporting to the Vice President, Commercial Operations, the Director, Field Support & Reporting will play a key role in supporting our first commercial launch and future growth.
• This role is responsible for driving field operations effectiveness through reporting, analytics, systems management, and process optimization.
• Define, create and produce reporting and analytics for field teams and field leadership.
• Lead incentive compensation process including design, operations, exception management, reporting.
• Lead targeting, segmentation and alignment work including development and implementation of target lists as well as alignment updates.
• Collaborate and work with internal teams and third-party vendors in supporting the operations of MDM, Data Lake, DQM, Catalog, Governance, Analytics, Commercial Reporting and any other related processes.
• Manage Veeva CRM from commercial standpoint including updating data in the CRM, responding to field requests/questions, and working with vendor and internal IT to deliver system enhancements.
• Identify and address operational problems and inefficiencies, report these to the management team and suggest solutions.

Director, Field Operations

Vice President

• Reporting to the Senior Vice President, Early Development and Clinical Pharmacology; establish and lead the Clinical Pharmacology, Pharmacometrics and DMPK function.
• Define strategic vision, operational frameworks, and best practices tailored to Disc Medicine’s portfolio and R&D goals.
• Lead clinical pharmacology and DMPK on cross-functional R&D teams; contribute to nonclinical and clinical development plans, study protocols, and decision-making at all stages.
• Apply quantitative methodologies including population PK/PD, exposure–response modeling, PBPK, and QSP to inform dose selection, clinical trial design, special population strategies, and regulatory submissions.
• Drive clinical pharmacology and DMPK strategy for INDs, CTAs, NDAs/BLAs; oversee authorship and review of key regulatory documents and engagement with global health authorities.
• Collaborate closely with Clinical Development, Regulatory Affairs, CMC, Innovation, Toxicology, and Biomarker teams to ensure integration of Clinical Pharmacology and DMPK throughout R&D.
• Maintain expertise in evolving approaches and represent Disc Medicine in external scientific forums, regulatory meetings, and industry collaborations.

Vice President, Clinical Pharmacology, Pharmacometrics, DMPK

Supply Chain

• Manage clinical supply planning and forecasting for Disc’s small molecule program
• Serve as member of the clinical study team and/or clinical drug supply team
• Review clinical study protocols to develop packaging/labeling designs, label pack timelines and distribution strategies
• Ensure supply demand is clearly communicated to the technical operations/QA team so manufacturing and release activities align with the organization timelines
• Collaborate closely with labeling and packaging CDMO’s to ensure operation dates align with clinical timelines
• Develop and maintain strong relationships with external vendor(s)/partner(s) critical to Disc objectives and deliverables
• Coordinate QP release for global studies
• Review pharmacy manuals and clinical site SOPs
• Budgeting, forecasting, and strategic planning activities for clinical trials
• Drive the sourcing of the clinical supply service provider as needed
• Coordinate the origination, translations, proofing and approval of clinical study labels
• Participate in the configuration and UAT testing of the IRT, if applicable
• Serve as primary contact and project manager for the labeling and packaging services provider associated with the clinical study
• Coordinate drug supply delivery timelines with Supply Chains operations planning, CMC and the label/pack service providers
• Monitor global clinical supply inventory at the depot and clinical site levels
• Maintain close communications with all internal groups to ensure adequate supply of clinical supplies throughout the duration of a clinical trial
• Meet with Clinical Operations as needed to update study assumptions and update supply plans
• Collaborate closely with Reg-CMC and Quality Assurance
• Serve as author and reviewer for IND and IMPD submissions, as applicable
• Provide visibility to potential risks in planned capacity and make recommendations with strategic direction
• Assist with creation or review of SOPs as needed

Associate Director, Clinical Supply Chain

Director

• Reporting to the Vice President, Marketing
• Develop and lead Disc’s thought leader engagement strategy across all therapeutic areas and life-cycle stages
• Define prioritization of national and regional thought leaders, tailoring engagement plans by specialty, geography, and influence
• Design and execute speaker bureau strategy: speaker identification, nomination, contracting, training, and retention
• Lead strategy and engagement for key medical conferences, including developing materials and engagements
• Partner with HCP Marketing to develop peer-to-peer content that is scientifically accurate, engaging, and compliant
• Drive scientific advocacy by fostering strong relationships between thought leaders and internal stakeholders (Medical, Marketing, Access)
• Lead end-to-end planning and execution of advisory boards and roundtables, ensuring strategic objectives and high-quality insights
• Lead identification of next generation influencers and speakers
• Translate thought leader feedback into actionable recommendations to shape marketing strategies, messaging, and launch planning
• Establish clear KPIs and performance dashboards for thought leader engagement (reach, quality of insights, program effectiveness, speaker utilization, etc.)

Director, Thought Leadership Strategy and Engagement

• Report to Head of ADQC in Technical Operations and lead the clinical QC function for Disc Medicine biologics pipeline programs from early development to commercialization
• Support selection, negotiation, and review of service agreements and statements of work with analytical and QC CDMOs
• Develop and manage relationships with external CDMO partners to ensure appropriate scopes of work and program expectations
• Guide qualification and validation of analytical methods to support GMP in-process, batch release and stability studies; review and approve protocols and reports
• Establish training and technical approaches to transfer analytical methods between development and QC testing sites
• Establish and implement product specifications, oversee outsourced GMP release testing, stability programs, and reference standard management at CDMOs
• Accountable for QC OOS/OOT/deviation investigations and identification of root cause and CAPA for testing-related issues
• Support quality assurance in product release activities and product shelf-life management
• Establish systems and procedures for product and reference standard trending and review trend reports periodically
• Author, review, and approve SOPs, protocols, reports, and change controls; support annual product review and annual report activities
• Represent quality control operations in regulatory and partner audits and author/review global health authority CMC dossier sections for clinical trials and commercial licensure
• Foster a positive workplace culture that prioritizes collaboration, accountability, and continuous improvement

Director, Analytical Development and Clinical Quality Control

• Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients with serious hematologic diseases by targeting heme biosynthesis and iron homeostasis.
• Regional Business Director (US East) responsible for strategically building a high-performing sales team to execute the U.S. commercial launch strategy.
• Oversee Salesforce-enabled lead programs and ensure compliant, science-driven customer engagement to achieve forecasted patient demand.
• Identify, recruit, lead, and develop a regional team of Rare Disease Specialists; drive field execution of national sales strategy and achieve regional revenue targets.
• Collaborate cross-functionally (Sales Operations, Training, Marketing, Medical Affairs, Market Access, Patient Services) to maximize sales opportunities and ensure aligned HCP engagement.
• Coordinate territory and regional performance metrics, optimize CRM adoption, and serve as the field voice to headquarters.
• Represent the company at national and regional conferences and ensure compliance with relevant regulations and policies.

Regional Business Director

Marketing Operations

• Reporting to the Vice President, Marketing, the Manager, Marketing Operations will provide commercial support services including congress & sponsorship management, literature fulfillment, HCP contracting, speaker programs and patient programs leadership.
• The role will additionally have responsibility for executing specific marketing projects.
• As part of a small and evolving team, this role offers a unique opportunity to contribute across multiple areas of commercial execution.
• The ideal candidate is detail-oriented, organized, and adaptable, with a strong interest in life sciences and a hands-on approach to teamwork.
• National Conference & Sponsorship Management: Lead planning and execution of National Conferences for assigned strategic pillar(s), partnering with cross-functional teams and vendors while serving as the primary point of contact for organizers.
• Lead all cross functional planning meetings, prepare and present pre-con and post-con materials to internal attendees.
• Speaker Programs: Lead speaker bureau development, annual speaker training, and program evolution in alignment with Marketing direction.
• Support program execution, metrics and KPI reporting, compliance requirements, and Sales team needs.
• HCP Contracting: Support commercial function on contracting HCPs and processing payment in a timely manner including speaker programs, patient programs, symposia and sales training.
• Project manage all physician engagements from the initial contracting phase in conjunction with marketing through to completion of invoicing/reimbursement form and processing payment in a compliant and timely manner.
• Literature Print & Fulfillment: Act as the primary point of contact between Marketing, Sales, and vendor for promotional literature print and fulfillment.
• Manage inventory levels, dissemination, expirations and forecasting for all printed promotional items within strategic pillar(s).
• Project manage the print process through to fulfillment, from initial quoting with alignment from marketers through to sharing drop shipment tracking to field sales team.
• Attend MLR for strategic pillar(s) and agency status meetings as needed.
• General Marketing and Project Management: Assist in the preparation and submission of promotional materials through the ad promo (Medical/Legal/Regulatory) review process
• Support execution of marketing tactics under the direction of senior marketing team members (e.g., digital campaigns, sales collateral, print and promotional material production)
• Help maintain marketing calendars, timelines, and status trackers