POSITION OVERVIEW:

As Disc Medicine transitions from a clinical-stage organization to a commercial-stage one, the company is introducing a new role: Director of Clinical Quality Control. The successful candidate will play a crucial role in driving the company’s growth and achieving strategic objectives.

The Director of Quality Control will manage stability studies for various small-molecule and biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include protocol design; coordination and execution of various stability studies at CDMOs; statistical analysis; and expiration dating.  Additionally, this role will oversee the end-to-end supply of reference standards for quality control testing, including sourcing/production, qualification, inventory and distribution, as well as lifecycle monitoring. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Head of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have at least 10 years of experience in quality control management in the pharmaceutical or biotech industry.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for stability and reference standard management for Disc Medicine’s clinical development programs. The technical responsibilities include:

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating. 
• Manage Quality System records for QC Stability: create, assess, review Deviations, Change Controls, CAPAs, and other applicable stability-related investigations and events
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

 REQUIREMENTS:

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Experience with method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced small molecules and biologics therapeutics.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

POSITION OVERVIEW:

Disc Medicine is seeking a detail-oriented and experienced Regulatory Operations Manager, reporting to the Head of Global Regulatory Operations. This full-time role will be instrumental in managing document compliance activities for regulatory submission documents, document publishing (e.g. IMPDs, meeting packages and CSRs), assisting with regulatory submission activities, performing Veeva RIM inputs, interacting with project team members and Regulatory vendors, authoring best practices and providing associated training as assigned, and other Regulatory Operations projects as needed.

RESPONSIBILITIES:

Regulatory Submission Quality & Publishing Operations (~50%)

• Perform submission readiness quality checks and updates on MS Word and PDF files per company style guide and health authority guidance.
• Execute report and multi-file publishing activities and manage related processes to meet regulatory standards.
• Manage Veeva RIM HA Questions, Meetings and Commitment databases
• Assist Regulatory Operations submission manager with Veeva RIM data entry and submission-related tasks (pre- and post-dispatch).
• Manage investigational maintenance submission tasks as resources allow or are prioritized by management, e.g. IND investigator submissions. Oversight to commensurate with experience.
• Assist submission team members with document uploads.

Regulatory Documentation Standards & Training (~30%)

• Create and manage document templates used for regulatory submissions.
• Manage StartingPoint training documentation and serve as SME to deliver training to regulatory document authors.
• Perform Veeva RIM metadata audits as assigned
• Review and/or author best practices, work instructions, and SOPs for regulatory operations tasks and present as requested.

Cross-Functional Collaboration & Process Improvement (~20%)

• Interact with functional document owners to communicate findings and negotiate resolution steps.
• Participate in Regulatory Operations process improvement and system initiatives
• Provide input for applications associated with the job function and participate in User Acceptance Testing (UAT) as requested.

 REQUIREMENTS:

• High school diploma or equivalent required; Associate’s Degree or above preferred.
• 5-7 years of direct experience. Level to commensurate with task and leadership experience.
• High knowledge of various document types (CMC, Nonclinical, Clinical, Regulatory) and submission readiness expectations.
• Expert MS Word, StartingPoint template, Adobe Acrobat Pro and Toolbox Pharma plug-in experience.
• Prior Clinical Study Report and multi-document publishing experience required.
• Proven ability to work independently with minimal to no supervision for document compliance and document publishing tasks.
• Intermediate to advanced work experience with Veeva RIM Submissions and Submissions Archive applications with knowledge of various RIM record metadata.
• Driven to meet deadlines with high attention to detail and quality.
• Proven ability to effectively multi-task and work under tight deadlines; must possess excellent organizational skills.
• Effective communication and interpersonal skills; must be self-motivated with eagerness to learn and desire to grow professionally.
• Personal attributes include: flexibility and integrity, good judgment and decision-making skills, action- and results-oriented, collaborative and team-oriented
• Occasional travel required, as needed.
• Prior experience with submission management and pre-publish compilation tasks for various IND submission types and subsequent post-publish eCTD review processes a plus.
• Prior UAT testing experience is highly desirable.

POSITION OVERVIEW:

Disc Medicine is seeking an experienced, versatile and highly motivated attorney to join our Legal team and help to build our business while mitigating risk through the efficient negotiation of a broad range of life sciences agreements.  The successful candidate will possess significant experience in drafting and negotiating complex and routine life science agreements, including master service agreements, research and development agreements, manufacturing agreements, license agreements, consulting agreements, confidentiality agreements, clinical trial agreements, work orders and other vendor agreements. This position will report to the Vice President, Corporate Counsel, and collaborate extensively across the company, including our commercial, medical, clinical, finance, and other teams.

RESPONSIBILITIES:

• Draft, review and negotiate a range of agreements, including master service agreements, research and development agreements, manufacturing agreements, license agreements, consulting agreements, confidentiality agreements, clinical trial agreements, work orders and other vendor agreements, across the company's business
• Collaborate with employees across the company with respect to contract requests in a manner that efficiently advances our corporate goals by promoting successful contract execution
• Pro-actively identify risks inherent in contract terms, including legal, financial and reputational risks, and develop practical, business-oriented solutions to appropriately mitigate such risks
• Provide legal interpretation of agreements and other related business matters and provide practical, business-orientated legal advice
• Develop and refine contract templates and assist with the administration/oversight of contract systems and processes, such as our contract management system, to ensure efficiency of operations
• Advise on other legal matters that arise across various functions within the company, as appropriate
• Interface with external legal resources, as appropriate

 REQUIREMENTS:

• D. from nationally accredited law school and admission in good standing to any state bar in the United States
• 10-12+ years of relevant experience in an in-house legal department within the biotechnology or pharmaceutical industry
• Strong negotiation, contract interpretation, and contract drafting skills
• Strong communication and interpersonal skills, including proven ability to interact effectively with individuals from multiple departments at all levels of the organization
• Demonstrated ability to handle multiple responsibilities simultaneously and perform at a high caliber in a fast-paced environment
• Commitment to professionalism and ethical conduct, including ability to handle confidential and/or sensitive information
• Self-motivated with the ability to work independently while executing on responsibilities within a highly collaborative environment
• Experience in an emerging, publicly traded company environment is a plus

POSITION OVERVIEW:

Disc’s Corporate Strategy group partners across the organization to advance our strategic agenda and support initiatives that will drive the company forward. The Senior Manager, Strategy and Corporate Development will be responsible for supporting high-impact strategic and growth initiatives, including corporate planning, transactions, new product planning, commercial assessment, market and competitive intelligence, assisting with commercial preparations, and corporate communications.

RESPONSIBILITIES:

• Corporate Strategy (~35%)
  • Support strategic initiatives that will address mission-critical questions and position Disc for future success
  • Support commercial preparation activities, including market shaping, launch planning, value proposition development, and positioning
  • Monitor, understand and prioritize external trends of relevance to the company, and help determine how Disc should prepare and/or respond
• Competitive Intelligence and Market Insights (~15%)
  • Critically evaluate available information about Disc’s diseases of interest and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
  • Support consulting and market research projects to gain deeper insight into markets of interest for Disc
• New Product Planning (~25%)
• Research, evaluate and recommend potential growth strategies through expansion into new therapeutic categories, markets, and related businesses
• Lead analyses of commercial opportunities (including epidemiology modeling and detailed revenue projections) related to corporate/business development initiatives
• Communications Support (~15%)
  • Support external communications, including drafting press releases and developing corporate presentations
  • Maintain and update corporate website
• Business Development (~10%)
  • Assist business development processes by providing expertise for in- or out-licensing, partnering and acquisition activities, as well as contributing to deal sourcing, due diligence, and negotiations
  • Support development and maintenance of Disc valuation model and supporting documents

 REQUIREMENTS:

• Bachelor’s degree required
• Minimum of 4 years of experience at a top-tier strategic consulting firm or investment bank, preferably with healthcare and pharma industry experience, or at a biotech or pharma company in a similar role
• Demonstrated ability to independently lead projects or project modules, including formulation of research plan, conducting primary or secondary market research, identifying and managing vendors, performing analysis, and distillation of findings into recommendations for management consideration
• Strong analytical skills with the ability to interpret complex data and market insights
• Proven ability to develop deep working knowledge of clinical programs and therapeutic landscapes
• Ability to create and deliver effective presentations to working teams and senior management
• Ability to create complex excel-based forecasts and valuation models
• Ability to thrive in a fast-paced, dynamic startup environment with a hands-on, proactive approach
• A hands-on approach with a willingness to handle both high-level strategy and day-to-day execution
• Strong communication skills, can comfortably lead meetings with mid/senior-level management

POSITION OVERVIEW:

Disc Medicine is seeking a highly skilled Corporate Accounting Manager to join its Finance organization and support the company’s financial reporting, control, and compliance requirements as a public, clinical stage biopharmaceutical company. Reporting to the Director of Accounting, this role will be responsible for leading critical components of the monthly, quarterly, and annual close processes; ensuring accurate and timely financial reporting in accordance with U.S. GAAP; and maintaining an effective internal control environment in compliance with Section 404(b) of the Sarbanes Oxley Act.

The Corporate Accounting Manager will oversee general ledger activities, including the preparation and review of complex journal entries, account reconciliations, and variance analyses, and will manage accrual processes across research, clinical operations, CMC, G&A, and commercial functions. This position will partner closely with FP&A and cross functional stakeholders to validate spend, support forecasting and budgeting activities, and develop and maintain clinical trial accrual models to ensure appropriate recognition of costs incurred.

In addition, the Corporate Accounting Manager will serve as a key liaison for internal and external auditors, supporting integrated audits and quarterly reviews through the execution, documentation, and testing of internal controls, as well as the preparation of audit schedules and supporting materials. The ideal candidate brings strong technical accounting knowledge, a disciplined approach to controls and compliance, and the ability to operate effectively in a fast paced, evolving public company environment while contributing to continuous improvement of accounting processes and systems.

RESPONSIBILITIES:

• Play a lead role in the monthly, quarterly, and annual close processes, ensuring timely and accurate financial reporting.
• Understands and applies U.S. GAAP, has strong internal control structure understanding and has willingness to challenge current processes or procedures as a trusted business partner.
• Prepares / reviews complex journal entries, account reconciliations, and variance analyses with a high degree of accuracy managing the monthly, quarterly, and year‑end close processes, ensuring timely and accurate financial reporting in accordance with US GAAP.
• Lead the monthly accrual process across research, clinical operations, CMC, G&A, and commercial functions, ensuring expense recognition reflects operational activity.
• Partner closely with FP&A, Clinical Operations, CMC, and other cross‑functional teams to validate spend and inform accrual estimates.
• Develop, maintain, and review clinical accrual models for multiple clinical programs across various phases, ensuring accurate recognition of costs incurred but not yet invoiced.
• Serve as a key point of contact for interim and year-end internal and external integrated audits, preparation of schedules, performance / documentation of controls and providing supporting documents.
• Analyze and explain variances between actual results, forecasts, and budgets to management and external auditors.
• Other duties as assigned.

 REQUIREMENTS:

• Bachelor’s degree in Accounting, Finance or related field
• 5+ years of progressive accounting experience, typically including a combination of public accounting and biotechnology or life sciences industry experience.
• Strong knowledge of US GAAP, Certified Public Accountant (CPA) is preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.
• Experience with ERP systems such as NetSuite and Coupa (preferred). Advanced Excel skills required.
• Minimum of 3 years of experience (either as an auditor or in industry) with internal controls under Section 404(b) of the Sarbanes-Oxley Act (SOX). Working knowledge of drug development process within the biotech/pharmaceutical industry, including clinical trial accruals is required.

POSITION OVERVIEW:

Disc Medicine’s Drug Metabolism and Pharmacokinetics (DMPK) team is seeking an experienced scientist to support the application of pharmacokinetic (PK) and pharmacodynamic (PD) sciences in our drug discovery and development portfolios, with more focus on biologics programs.

As a key member of the cross‑functional teams, you will apply in vitro, in vivo, and modeling approaches to characterize the absorption, distribution, metabolism, excretion (ADME), and PK/PD properties of small molecules and biologics.

You will serve as a DMPK project representative and contribute across all stages of portfolio advancement, from early compound screening and optimization through IND‑enabling studies and regulatory submissions. Responsibilities include experimental design, data analysis and interpretation, human PK and efficacious dose projection, reporting, and strategic guidance.

This role requires regular interaction with internal and external partners to ensure timely, high‑quality delivery of ADME/PKPD data and to drive DMPK strategy for both Discovery and Development programs.

RESPONSIBILITIES:

• Serve as the DMPK representative on biologics and/or small molecule project teams, providing scientific and strategic leadership.
• Design, conduct, interpret, and report in vitro ADME, in vivo PK, and PK/PD studies.
• Develop and maintain compound selection criteria to support consistent decision‑making across projects.
• Partner effectively with modeling and simulation experts, toxicologists, and clinical pharmacologists for human PKPD prediction, toxicology and clinical study support.
• Summarize and present scientific results to project teams, leadership, and broader stakeholders.
• Oversee external CRO partners to ensure high‑quality data generation within budget and timelines.
• Contribute expert‑level guidance to regulatory submissions for biologics and/or small molecules.

 REQUIREMENTS:

• MS in DMPK, biology, chemistry, or related field with 8+ years of relevant experience, or PhD (or equivalent) with 5+ years of relevant industry experience.
• Demonstrated expertise in large‑molecule PK, PKPD, and general discovery or development areas.
• Strong working knowledge of ADME, PK, PKPD for small molecules is an important plus.
• Proven ability to evaluate and apply innovative PK and PK/PD approaches to predict human PK, generate hypotheses, design studies, inform clinical plans, and support regulatory filings is highly preferred.
• Experience working effectively and collaboratively with cross‑disciplinary teams; ability to lead, influence, and contribute to decision‑
• Excellent written and verbal communication skills.