Disc Medicine is a biopharmaceutical company dedicated to transforming the lives of patients with hematologic disorders.
We are building a unique portfolio of innovative, first-in-class therapeutic candidates that affect fundamental pathways of red blood cell biology.

Disc Medicine

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operations

Disc Medicine is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for patients suffering from hematologic diseases. The company is dedicated to addressing the needs of individuals with rare and chronic blood disorders by turning scientific discoveries into effective treatments that aim to improve patients' lives and alleviate suffering. Their team, composed of skilled scientists and industry experts, strives to make a significant impact in the field of hematology.

Disc Medicine is a biopharmaceutical company dedicated to transforming the lives of patients with hematologic disorders. We are building a unique portfolio of innovative, first-in-class therapeutic candidates that affect fundamental pathways of red blood cell biology.

• Monitor financial approval cadence closely and coordinate budget management within teams
• Build relationships with key-decision makers in finance and SMEs
• Work closely with internal teams including CMC leader and CMC functions including Drug Substance, Drug Product, Supply Chain, as well as Quality and Regulatory organizations for small molecules/biologics
• In collaboration with technical leads, develop and manage risk mitigated CMC development strategies and project plans
• Coordinate CMC team meetings coordinating with CMC leads, including assembly of agendas and meeting minutes
• Ensure effective cross-function and cross-project communications in and out of internal development teams
• Support technical leads with vendor management but not limited to contract review and negotiation, timeline management, and quarterly business review meetings.
• Collaborate with finance to forecast and manage the budget and quarterly accrual for all tech ops activities
• Support tech ops with Request for Proposal, contracts, POs and invoice approvals.

Associate Director – Manufacturing Operations

Associate Director in Manufacturing Operations at Disc Medicine. Driving growth and strategic objectives in a hybrid role.

medical-director

• Contribute to the overall clinical development strategy for assigned programs.
• Partner with the Executive Medical Director to define clinical development plans, trial designs, and program milestones.
• Provide medical and scientific input into target product profiles, study protocols, investigator brochures, and regulatory documents.
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Help to determine appropriate advisory boards experts
• Serve as medical monitor for clinical trials, ensuring subject safety and data integrity.
• Provide clinical guidance to operational teams, investigators, and external partners.
• Review and interpret clinical data, prepare clinical study reports, and support publication activities.
• Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports
• Organize and present at relevant clinical advisory boards, DMC and medical/scientific meetings
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure seamless execution of clinical programs.
• Represent Clinical Development in internal governance meetings and cross-functional program teams.
• Support business development and alliance management activities as needed.
• Contribute to regulatory submissions (INDs, NDAs, BLAs, etc.) and interactions with global health authorities.
• Ensure compliance with GCP, ICH guidelines, and company SOPs.
• Prepare abstracts and manuscripts for publication/presentation.
• Present clinical data to internal stakeholders, investigators, and at scientific conferences.
• Provide mentorship to junior medical or scientific staff.

Medical Director

Medical Director leading clinical development strategies for innovative hematology therapies. Collaborating with teams to ensure compliance and execution of clinical programs.

research-scientist

• Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function.
• Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work.
• Provide oversight into external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review and edit SOPs, protocols, reports, and quality related documentation.

Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control

Principal Scientist/Associate Director contributing to late-stage analytical development for biopharmaceuticals at Disc Medicine. Overseeing method development and compliance with regulatory standards in a hybrid work environment.

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

Director of GMP Quality Assurance overseeing the Biologics manufacturing pipeline at Disc Medicine. Ensuring quality oversight and compliance for late-stage clinical trials across diverse teams.

• 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

Director of Field Operations at Disc Medicine driving field operations effectiveness for a biopharma launch. Responsible for reporting, analytics, systems management, and process optimization in a hybrid role.

Disc Medicine

About the company

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5 jobs found

Associate Director – Manufacturing Operations

Disc Medicine

Medical Director

Disc Medicine

Principal Scientist/Associate Director, Analytical Development, Clinical Quality Control

Disc Medicine

Director, GMP Quality Assurance

Disc Medicine

Director, Field Operations

Disc Medicine