Manufacturing & Production

Afton Scientific LLC

Buyer Planner

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking an organized, proactive, and detail-oriented Buyer Planner to join our Supply Chain team. This position plays a critical role in ensuring that the materials needed to support manufacturing and project activities are available when needed while maintaining appropriate inventory levels and strong supplier relationships.

This is an excellent opportunity for an employee who enjoys planning, problem-solving, working with suppliers, and coordinating across departments to support successful manufacturing operations.

**Compensation**

**$29.00 to $36.00**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

· Obtain supplier quotes and procure materials needed to support manufacturing and project requirements.

· Serve as the primary point of contact for assigned suppliers and maintain productive supplier relationships.

· Monitor open purchase orders and work with suppliers to track and maintain expected delivery dates.

· Closely manage critical material orders to help prevent disruptions to manufacturing.

· Monitor raw material, in-transit, and consignment inventory levels.

· Maintain MRP planning data and coordinate material deliveries to minimize both shortages and excess inventory.

· Perform production and project material planning, including creating and maintaining material allocations and pick lists.

· Author and review supply chain and quality-related documentation, including SOPs, specifications, Supplier Non- Conformances, and quarterly DEA reporting.

· Assist with cycle counts and physical inventories to support inventory accuracy.

· Participate in continuous improvement initiatives that improve supply chain efficiency, compliance, and cost effectiveness.

**Minimum Qualifications**

· High school diploma or equivalent.

· Previous inventory management experience.

· Proficiency with Microsoft Office, primarily Outlook, Word, and Excel.

· Strong organizational skills and attention to detail.

· Strong communication and issue-resolution skills.

· Ability to manage multiple priorities and deadlines effectively.

· Ability to work effectively in a fast-paced and changing environment.

· Demonstrated initiative and a proactive approach to problem-solving.

**Preferred Knowledge and Experience**

· Experience with SAP or another ERP system.

· Previous experience purchasing or procuring materials.

· Experience working within a cGMP-regulated environment.

· Production planning experience.

· Associate or bachelor's degree in Supply Chain or a related field.

· Strong negotiation skills.

· Experience working with suppliers and resolving material availability or delivery issues.

**Key Competencies**

· Planning & Organization

· Attention to Detail

· Supplier Relationship Management

· Communication & Collaboration

· Negotiation

· Problem Solving

· Inventory Management

· Accountability & Follow-Through

· Continuous Improvement

**What You'll Gain**

· Hands-on experience in procurement, production planning, and inventory management.

· Increased exposure to supplier management and manufacturing operations.

· Experience using supply chain planning processes and ERP systems.

· Opportunities to contribute directly to improvements in inventory accuracy, material availability, and operational efficiency.

· An opportunity to develop additional skills and pursue continued career growth within Afton Scientific.

Virginia

Senior Buyer Planner

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking an experienced, proactive, and results-oriented Senior Buyer Planner to join our Supply Chain team. This position plays a key role in leading the procurement, planning, and management of raw materials and packaging needed to support manufacturing operations and assigned projects.

The Senior Buyer Planner will have significant responsibility for supplier relationships, forecasting, inventory strategy, material availability, and supply-risk mitigation. This is an excellent opportunity for an experienced supply chain professional who enjoys solving complex problems, developing supplier relationships, and improving the systems and processes that keep manufacturing operations running successfully.

**Compensation**

**$72,000 – $90,000 per year**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

· Obtain competitive quotes and procure materials required to support manufacturing and project needs.

· Serve as the primary point of contact for assigned suppliers and actively manage supplier relationships.

· Monitor open purchase orders, supplier delivery performance, and critical material orders.

· Manage raw material, in-transit, and consignment inventory while maintaining accurate MRP planning data.

· Coordinate material availability to support production schedules while minimizing both shortages and excess inventory.

· Perform production and project material planning and assist with forecast planning.

· Create and maintain material allocations and pick lists.

· Define, review, and maintain inventory policies, including safety stock levels, reorder points, and lot sizes.

· Identify potential supply risks and develop appropriate mitigation plans.

· Participate in internal and external audits as required.

· Support Afton's Supplier Qualification Program.

· Author and review supply chain and quality-related documentation, including SOPs, specifications, Supplier Non-Conformances, regulatory reports, supplier audit reports, and new supplier documentation.

· Lead continuous improvement initiatives designed to improve supply chain efficiency, reliability, compliance, and cost effectiveness.

**Minimum Qualifications**

· Associate or bachelor's degree; degree requirement may be substituted with at least five years of experience in purchasing, material planning, and/or vendor management.

· Previous inventory management experience.

· Demonstrated experience procuring materials.

· Proficiency with SAP or another ERP system.

· Proficiency with Microsoft Office, primarily Outlook, Word, and Excel.

· Strong organizational skills and attention to detail.

· Strong communication, problem-solving, and negotiation skills.

· Ability to manage multiple priorities and deadlines in a fast-paced environment.

· Demonstrated initiative and a proactive approach to identifying and resolving problems.

**Preferred Knowledge and Experience**

· Experience working within a cGMP-regulated environment.

· Production planning experience.

· Bachelor's degree in Supply Chain or a related field.

· Experience managing supplier performance and critical material requirements.

· Experience developing inventory strategies, including safety stock and reorder-point planning.

· Experience supporting supplier qualification or audit activities.

· Demonstrated experience identifying and mitigating supply-chain risks.

**Key Competencies**

· Strategic Planning & Organization

· Supplier Relationship Management

· Negotiation & Influence

· Inventory & Material Planning

· Problem Solving & Decision Making

· Risk Identification & Mitigation

· Communication & Collaboration

· Accountability & Follow-Through

· Continuous Improvement

What You'll Gain

· Increased ownership of critical procurement, planning, and inventory-management activities.

· Opportunities to influence supplier performance, material strategy, and production continuity.

· Experience developing inventory policies and supply-risk mitigation strategies.

· Exposure to supplier qualification, audits, regulatory documentation, and cGMP supply chain operations.

· Opportunities to lead continuous improvement initiatives and strengthen Afton's overall Supply Chain capabilities.

· Continued professional development and career growth within Afton Scientific.

Warehouse Associate I

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

- Serving clients in 18 Countries
- Successful NDA and ANDA drug registrations
- In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking a dependable and detail-oriented Warehouse Associate I to join our Materials team. This position plays an important role in supporting manufacturing operations by receiving, inspecting, storing, and moving materials while helping maintain accurate inventory and efficient warehouse operations.

This is an excellent opportunity for an employee who is organized, enjoys hands-on work, and is interested in developing experience within Afton's Supply Chain organization.

**Compensation**

**$19.00 – $24.00 per hour**

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

**Primary Responsibilities**

· Receive incoming materials and verify shipments against appropriate documentation.

· Inspect incoming materials for damage or defects and promptly report discrepancies.

· Complete required receiving and release documentation accurately and on time.

· Perform incoming material release checks, including garment processing and tray tests.

· Store and organize materials appropriately and efficiently.

· Perform inventory transactions, material releases, and system transfers.

· Conduct cycle counts and participate in physical inventories to maintain inventory accuracy.

· Deliver packages, collect Kanban cards, and support internal material movement throughout the facility.

· Load, unload, and move materials using forklifts, pallet jacks, and other warehouse equipment.

· Ensure materials are received, stored, and shipped safely and accurately.

· Maintain clean and organized warehouse and loading dock areas.

· Participate in continuous improvement activities that strengthen warehouse and supply chain operations.

**Minimum Qualifications**

· Strong organizational skills and attention to detail.

· Ability to maintain accurate records and documentation.

· Strong communication skills and a positive, team-oriented attitude.

· Ability to adapt to a fast-paced and changing work environment.

· Basic proficiency with Microsoft Office, primarily Outlook, Word, and Excel.

· Ability to manage multiple tasks and priorities effectively.

· Demonstrated initiative and a proactive approach to identifying and solving problems.

· Ability to read and write effectively.

**Preferred Knowledge and Experience**

· Previous warehouse, inventory management, receiving, or material handling experience.

· Experience with SAP or another ERP/inventory management system.

· Experience operating forklifts, pallet jacks, or other warehouse equipment.

· Associate or bachelor's degree.

**Physical & Work Requirements**

· Ability to lift up to 50 pounds as part of routine warehouse and material receiving activities.

· Ability to work primarily within a warehouse environment.

· Ability to wear a respirator and other required personal protective equipment.

· Regular on-site attendance is required.

**What You'll Gain**

· Hands-on experience supporting pharmaceutical manufacturing and Supply Chain operations.

· Experience with inventory management, receiving, material handling, and warehouse systems.

· Opportunities to participate in continuous improvement activities.

· An opportunity to develop additional skills and pursue future career growth within Afton Scientific.

Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops) GOFP

**About the job**

At **Afton Scientific,**  every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a **Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops)**  to support our growing biopharmaceutical operations at our **on-site facility in Charlottesville, Virginia.  _(Relocation + Sign On Bonus )_**

**Overview of this Position:**

The **Manufacturing Specialist - Aseptic - Fill Finish (Isolator Ops)**  plays a critical role in sterile pharmaceutical manufacturing by operating and maintaining isolator systems for aseptic filling processes. This position ensures compliance with Good Manufacturing Practices (GMP) and supports the production of high-quality injectable drug products in a controlled environment.

**Pay Details:**  Non-exempt position, range of $30 - $34 per hour, depending on level of experience.

**Non-Negotiable Requirements:**

• At least two (2) years of experience operating isolators in a sterile/aseptic manufacturing facility

• At least two (2) years of experience in a GMP manufacturing facility

**• At least one (1) year of experience with routine cleaning, decontamination, and setup of isolators according to SOPs.**

•High School Diploma or GED

**Preferred Requirements:**

• Experience working with Master Control, and/or SAP.

• Experience with cleanroom operations and environmental monitoring

•Experience with automated filling equipment and troubleshooting isolator

•Previous experience in pharmaceutical or biotech manufacturing

•Exceptional attention to detail and communication skills

•Bachelor’s degree in biology and /or Life Sciences

**Responsibilities Include:**

•Operate isolator systems for aseptic filling of sterile injectable products

•Perform routine cleaning, decontamination, and setup of isolators according to SOPs

•Handle sterile components and materials in compliance with aseptic techniques

•Complete batch records and controlled documentation accurately and timely

•Monitor and document environmental conditions and equipment performance

•Collaborate with Quality Assurance and Engineering teams to resolve issues and maintain compliance

•Participating in training and continuous improvement initiatives

•Maintain a clean and organized work environment in accordance with GMP standards

*Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods; using a computer; and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.*

Modex Therapeutics Ltd.

Manager, Technical Operations

**Company Overview**

ModeX Therapeutics, an OPKO Health company, is the leading clinical-stage biopharmaceutical company developing unique and proprietary-multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world's most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.

**Job Description**

The **Manager, Technical Operations** provides operational leadership for CMC development and clinical supply activities across global development programs. This individual serves as the functional owner for key Technical Operations outsourced and in-house processes, including stability and supply chain activities, while driving cross-functional alignment among internal and external stakeholders. The role is responsible for operational planning and execution including risk management and continuous improvement initiatives that support the successful CMC development and supply of clinical-stage products. This is a manager-level individual contributor position requiring strong technical judgment, commitment to quality, and the ability to influence outcomes. The ideal candidate is highly organized, detail-oriented, data-driven, and committed to operational excellence and accuracy.

**Core Responsibilities**

- Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution functions.
- Lead planning and execution of stability programs and shelf-life extension activities, including data review, trend analysis, risk assessment, and recommendations to support program decisions.
- Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
- Serve as the primary operational lead for testing, stability, and supply chain activities at CDMOs, CROs, and other external partners, ensuring alignment on timelines, deliverables, and quality expectations. Monitor partner performance, facilitate issue resolution, and support business reviews to drive operational excellence.
- Evaluate analytical and stability data to identify trends, assess operational and technical risks, and develop mitigation strategies to support program success.
- Collaborate with CMC leaders to maintain CMC operational plans, timelines, dashboards, metrics, risk registers, and management reporting to support informed and proactive decision-making.
- Lead operational readiness activities for analytical testing, clinical supply production, and distribution activities.
- Drive continuous improvement initiatives focused on operational efficiency, data management, business processes, and documentation practices.
- Lead CMC budget tracking, forecasting, purchase order management, and expenditure reporting, providing financial visibility and recommendations to leadership.
- Identify, assess, and proactively manage supply chain challenges and operational issues that may impact project timelines or clinical supply availability.
- Collaborate with CMC, Clinical Operations, Program Management, Finance, and external partners to track deliverables, communicate status, and escalate issues to leadership.
- Support CMC activities by preparing program updates, risk assessments, mitigation plans, and decision-support materials for leadership and cross-functional teams.

**Qualifications**

- MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related scientific discipline, with 5+ years of biopharmaceutical industry experience supporting clinical-stage development programs; or a BS in a related scientific discipline with 10+ years of relevant industry experience.
- Demonstrated experience leading complex CMC operational activities and cross-functional initiatives within a regulated environment.
- Understanding of biologics development, clinical manufacturing, analytical testing, stability programs, and clinical supply operations.
- Experience supporting clinical supply planning, inventory management, batch disposition activities, and external development and manufacturing partners.
- Proven ability to independently manage multiple programs, priorities, and external partners while driving execution against established objectives.
- Experience reviewing and interpreting technical documentation, manufacturing records, protocols, reports, investigations, and change controls to identify risks, and develop practical mitigation strategies.
- Experience with budget management, forecasting, resource planning, and financial tracking.
- Strong project management, organizational, and influencing skills, with the ability to facilitate alignment across diverse stakeholder groups.
- Excellent communication and presentation skills, including experience presenting recommendations and program status to senior leadership.

**_ModeX Therapeutics is an Equal Opportunity Employer_**

Massachusetts

Frederick National Laboratory for Cancer Research

RO Water Systems Specialist – Research Facility

**RO Water Systems Specialist – Research Facility**

Job ID: req4681

Employee Type: nonexempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Facilities Maintenance and Engineering (FME) Directorate is responsible for laboratory space, administrative space, infrastructure, campus landscape, planning and design, and construction management at Frederick National Laboratory for Cancer Research.

**KEY ROLES AND RESPONSIBILITIES**

The Reverse Osmosis (RO) Water Systems Specialist is responsible for the operation, maintenance, and optimization of high-purity water systems that support laboratory and research activities. This role ensures the consistent production of pure water that meets stringent quality standards for required scientific applications.

- Operate, monitor, and maintain RO and associated water purification systems (e.g., DI, EDI, UV, filtration units).
- Ensure a continuous supply of high-purity water (Type I, II, or III) for laboratory use
- Perform routine maintenance, including membrane cleaning/replacement, filter changes, and system sanitization.
- Monitor system performance metrics (pressure, flow rates, conductivity, resistivity, TOC) and adjust as needed.
- Conduct and document water quality testing in accordance with research and regulatory standards
- Troubleshoot and resolve system issues to minimize downtime and prevent disruption.
- Maintain detailed logs, calibration records, and compliance documentation.
- Collaborate with laboratory personnel, engineers, and facilities teams to support research needs.
- Ensure compliance with applicable standards (e.g., ASTM, CLSI, CAP, GLP, GMP, as applicable).
- Assist with system upgrades, validation, and commissioning activities.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of five (5) years of related experience is required.
- Previous experience with RO or high-purity waster systems.
- Knowledge of water quality parameters and analytical testing methods.
- Ability to read and interpret technical diagrams and system schematics.
- Strong troubleshooting and analytical skills.
- Proficiency with data logging systems and standard computer applications.
- Experience providing support within research laboratory, pharmaceutical, biotechnology, or government facility environments.
- Familiarity with validation protocols (IQ/OQ/PQ) and documentation practices.
- Knowledge of automated control systems (PLC/SCADA).
- Physical and Environmental Requirements: Ability to routinely lift and carry up to 50 pounds; climb stairs and ladders; bend, stoop, and work in confined spaces. Work may involve exposure to airborne particulates, vapors, and elevated noise levels.
- Must have and maintain a valid State Driver's License issued by the state in which the candidate resides. Must have no more than three (3) demerit points in the previous twelve (12) months or five (5) demerit points in the preceding thirty-six (36) months as determined by the Leidos Biomed Use of Government Owned or Leased Vehicles Policy.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Certification in water treatment operations.

**JOB HAZARDS**

- This position is subject to working in or have the potential to exposure to high noise levels for extended periods of time required medical clearance.

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

59,600.00 - 87,633.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

\#LI-LR1

Maryland

Sanofi US

US MDM and Supply Chain Operations Specialist

**Job title:** US MDM and Supply Chain Operations Specialist

**Location:** Waltham, MA

**About the Job**

The **US MDM & Supply Chain Operations Specialist** is a key operational role within the mRNA Center of Excellence (CoE). Reporting to the Business Excellence Manager, the incumbent applies functional expertise in SAP S/4HANA and Supply Chain management to execute daily Master Data operations, ensure data integrity, and support continuous improvement initiatives across the "R&D to GMP" lifecycle.

This role acts as an operational bridge between local US operations, global digital teams, and external partners (EBIO, IDT, 3PL), ensuring seamless material data setup, standard process compliance, and reliable system workflows. Additionally, this position provides hands-on operational support for **Single-Use Technologies (SUT)**  receiving and outbound shipment preparation for the PD&I team, working in close collaboration with the **Logistics & Distribution Manager**.

Join the team protecting half a billion lives every year with next-gen science,

mRNA innovation, and AI-driven breakthroughs. In Vaccines, youll help advance prevention on a global scale - and shape the future of immunization.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

1. **SAP Operations & Digital Continuous Improvement**

- **System Key User & Operational Support:**  Serve as a Subject Matter Expert (SME) and Key User for SAP S/4HANA Supply Chain modules (Planning, Procurement, EWM). Troubleshoot routine system issues and support end-users.
- **Process Enhancement Support:**  Assist in identifying bottlenecks processes and contribute to the deployment of system enhancements that improve operational efficiency.
- **Flow Execution:**  Execute and monitor system configuration for end-to-end flows involving internal manufacturing facilities and strategic external partners (EBIO, IDT).
- **UAT Coordination:**  Coordinate and execute User Acceptance Testing (UAT) scripts for new feature rollouts, system patches, or global upgrades, verifying alignment with US operational requirements.

**2. Master Data Management (MDM) & Execution**

- **Policy Compliance:**  Adhere to US Master Data Management (MDM) governance standards, ensuring full compliance with cGMP regulations and ALCOA+ data integrity principles.
- **Data Creation & Parameterization:**  Responsible for hands-on creation and maintenance of Material Masters (GMIDs), Bills of Materials (BOMs), and Resources in SAP S/4HANA. Ensure accurate setup of technical parameters (lead times, safety stocks, procurement types).
- **Lifecycle Support:**  Facilitate material status transitions along the "R&D to GMP" lifecycle in close coordination with Process Development & Industrialization (PD&I) and Quality Assurance.
- **Cross-Functional Collaboration:**  Partner with the Raw Materials (RM) team and Quality Control to verify master data accuracy against active quality specifications and vendor master data.
- undefined

**3. SUT Logistics & External Warehouse Operational Support**

- **PD&I Logistics Assistance:**  Support the Process Development & Industrialization (PD&I) team with Single-Use Technologies (SUT) inventory coordination, including receiving verification and preparation for outgoing shipments to/from external warehouses (3PL).
- **Collaboration with Logistics Management:**  Work in close partnership with the **Logistics & Distribution Manager** to align master data parameterization with physical material handling, stock movements, and storage requirements for SUT components.

**External Warehouse Alignment:**  Coordinate with external 3PL facilities to ensure material availability, correct labeling, and smooth staging of SUT components for R&D and clinical supply needs.

**4. Continuous Improvement & Operational Enablement**

- **Standardization:**  Support the local implementation of global Sanofi Core Model SAP workflows and standard operating procedures (SOPs).
- **Operational Assistance:**  Provide operational support for procurement order issues, GMP receiving alignment, and labeling master data verification.
- **RFID Project Support:**  Support the operational deployment and daily maintenance of RFID tracking solutions within US facilities and external 3PL warehouses.
- **User Training:**  Deliver hands-on training and guidance to local end-users on SAP master data entry, best practices, and new digital tools.

**About You**

**Basic Qualifications**

- **Education:**  Bachelors degree required, or Masters degree preferred in Supply Chain Management, Information Systems, Business, or Engineering, or related disciplines.
- **Experience:**  Minimum 4 years of relevant experience in Supply Chain operations, preferably within Pharmaceutical, Biotech, Healthcare, Life Sciences, or other industries, with a focus on SAP Master Data Management and digital tools implementation
- **SAP Expertise:**  Solid hands-on experience with SAP S/4HANA or ECC (Supply Chain / Master Data modules). Ability to accurately navigate and update Material Masters, BOMs, and master records.
- **GMP & Data Integrity:**  Clear understanding of cGMP regulations and ALCOA+ data integrity principles in a regulated biopharma environment.
- **Supply Chain Fundamentals:**  Understanding of MRP (Material Requirements Planning) parameters and lifecycle management from development to clinical/commercial GMP stages.

**Soft Skills**

- **High Attention to Detail:**  Demonstrates strong rigor and a "right-first-time" mindset in data entry and technical parameter setup.
- **Collaborative & Customer-Oriented:**  Ability to work effectively in a cross-functional matrix team and interface constructively with local ops, global digital teams, and external vendors.
- **Problem-Solving Skills:**  Pragmatic approach to troubleshooting system error messages, master data discrepancies, or process delays.
- **Communication:**  Clear communication skills, both written and verbal, for technical documentation, user training, and daily stakeholder coordination.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
- Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
- Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#LI-Onsite

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Deputy Director of DS Manufacturing Quality Systems

**Job Title**: Deputy Director of DS Manufacturing Quality Systems

**Location:** Pearl River, NY

**About the job**

As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization spanning Principal Investigators, Technical Writers, and Quality Systems Support Associates responsible for the full lifecycle of manufacturing quality records: deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates. You'll keep investigations on track, products moving, and patients supplied, all while driving a culture of continuous improvement and operational excellence. You'll be a key voice in audits and regulatory inspections, a coach to your team, and a connector across functions. If you thrive in a fast-paced, regulated environment where your decisions carry real business and patient impact, this role is for you.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

**About Sanofi**

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

**Main responsibilities**

- Lead and develop an agile Quality Systems team including Principal Investigators, Technical Writers, and Quality Systems Support Associates coordinating work assignments to meet fluctuating business needs while sustaining a strong learning and development culture
- Own on-time closure of Drug Substance Manufacturing deviation investigations, CAPAs, effectiveness checks, and periodic reviews of departmental quality documents to meet site performance metrics and product release timelines
- Identify and resolve roadblocks by coordinating with support groups to ensure the Manufacturing Quality System Matrix remains current and comprehensive
- Review deviations, CAPAs, and other quality records for completeness, and conduct management-level review of minor, major, and critical events ahead of Quality Assurance review
- Oversee timely and accurate document updates within the Quality Management System (QMS), ensuring documentation remains current, compliant, and audit-ready
- Coach and develop the Quality Systems team, providing continuous feedback and challenging growth opportunities while reinforcing Sanofi's culture, values, and cGMP compliance standards
- Lead cross-functional engagement with key stakeholders (Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance) to build consensus and drive timely closure of quality records
- Partner closely with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy, audit readiness, and regulatory compliance priorities
- Serve as the site representative during internal and external audits and regulatory inspections, confidently defending investigation write-ups and quality documentation on behalf of the team
- Champion a continuous improvement culture by identifying and driving new tools, process changes, and cost-reduction initiatives that reduce deviations and improve cycle time efficiency across the Quality System
- Communicate progress, updates, and escalations accurately and effectively in writing and verbally across multiple levels of the organization and to regulatory agencies
- Ensure all Quality System operations are conducted in full compliance with cGMPs
- Available to work extended and flexible hours, including weekends, as business needs require

**Decision-Making Matrix (DAI)**

The Deputy Director, DS Manufacturing Quality Systems plays a leadership role in decision-making processes across quality systems, manufacturing operations, and regulatory compliance. Responsibilities are defined as follows:

**Deviation, CAPA, and Quality Record Closure**

- **D (Decider)**

Decides on investigation scope, risk classification, and closure readiness for deviations, CAPAs, and effectiveness checks in partnership with QA.

Approves final quality records prior to Quality Assurance review.

**Quality Systems Team Development and Work Assignment**

- **D (Decider)**

Assigns work, prioritizes investigations and quality documentation tasks, and determines team development plans and coaching strategies.

**Cross-Functional Consensus Building and Escalation**

- **A (Accountable)**

Accountable for facilitating cross-functional alignment with Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance to resolve roadblocks and drive closure.

Escalates unresolved issues to senior leadership and support groups as needed.

**Site Quality Strategy, Audit Readiness, and Inspection Defense**

- **A/I (Accountable/Informed)**

Partners with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy.

Accountable for representing the site and defending quality records during audits and inspections.

Informed of broader site quality strategy and regulatory intelligence.

**Continuous Improvement Initiatives and Process Changes**

- **D/A (Decider/Accountable)**

Identifies, proposes, and decides on process improvements, new tools, and cost-reduction initiatives within the Quality Systems organization.

Accountable for driving implementation and measuring impact on deviation reduction and cycle time efficiency.

**QMS Document Updates and Periodic Reviews**

- **A (Accountable)**

Accountable for ensuring timely and compliant updates to departmental quality documents and periodic reviews within the QMS.

Delegates execution to team members but retains accountability for completeness and compliance.

**cGMP Compliance and Regulatory Communication**

- **A (Accountable)**

Accountable for ensuring all Quality Systems operations are conducted in compliance with cGMPs.

Communicates progress, updates, and escalations to regulatory agencies and senior leadership.

**About You**

**Basic Requirements:**

- Bachelor's degree in Life Sciences, engineering, Business or any related field.
- 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment, with demonstrated experience leading cross-functional initiatives, projects, or quality systems.
- Strong track record making risk-based decisions independently and managing multiple high-priority, high-visibility deadlines in a dynamic setting
- Demonstrated ability to lead cross-functional consensus-building with stakeholders across Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance
- Excellent written and verbal communication skills, with the ability to engage and influence stakeholders across all levels of the organization and with regulatory agencies.

**Nice to Have:**

- Prior experience managing direct reports or technical teams in a regulated environment is preferred but not required. Equivalent experience leading quality systems, project teams, or independent contributors will be considered.

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#VHD

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

New York

Clinical Supply Chain Project Leader

**Job title**: *Clinical Supply Chain Project Leader*

- *Location: Cambridge, MA*

**About the Job**

The Clinical Supply Chain Project Leader (CSC-PL) is accountable for IMP supply with respect to timelines, quality and budget for a given project.

The CSC-PL is responsible to:

- Defines and implements the CSC Strategy at project level.
- Oversees study management activities ensuring adherence to plan.
- Represents CSC at project level.

The CSC-PL will also ensure clear, concise, consistent, and timely communication with stakeholders and act as a change agent through the leadership of global initiatives targeting process improvement and engaging all partners throughout the clinical supply chain.

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main responsibilities:**

**CSC Strategy & Implementation**

- Define and implement clinical supply chain strategy aligned with CSC KPIs and project objectives
- Assess study design feasibility (ID study card, Abbreviated Protocol stages) and optimize project delivery
- Influence Label &Pack outsourcing and distribution network strategy decisions
- Monitor supply chain performance (cost, lead times, quality) using KPIs and digital tools
- Drive continuous improvement and innovation across clinical supply chain operations

**Study Management Oversight**

- Lead CSC-Study Leaders and oversee all operational activities ensuring compliance with GCP/GMP standards
- Ensure CSC strategy harmonization across multiple trials with adherence to timelines and budget
- Monitor plan execution, identify risks, and implement mitigation plans
- Identify opportunities to streamline processes and reduce lead times and costs
- Serve as primary point of contact for project team and coordinate PAI preparation

**CSC Representation & Stakeholder Communication**

- Provide CSC expertise and contribute to project decision-making in project meetings.
- Escalate IMP/device/AxMP/comparator issues and propose mitigation strategies
- Interact with GPH, CMC leaders, and Clinical leaders to integrate CSC requirements into project strategy
- Report progress and issues to CSC Leadership Team
- Facilitate knowledge sharing and provide feedback on contractor performance

**About You**

Education:

- Bachelors degree with at least 5+ years OR Master's degree with at least 3+ years preferably in Health Sciences or related disciplines (Engineering, Pharmacy, Chemistry, Biology, etc.)

Experience & Technical Skills:

- Experience in pharmaceutical industry, preferably within clinical supply chain, clinical operations, or manufacturing environments.
- Project Management experience

Preferred Qualifications:

- Experience with GxP regulations and IMP requirements
- Any experience with N-SIDE forecasting systems, IRT systems preferred
- Risk management experience.

Soft Skills:

- Demonstrated leadership experience in engaging and ensuring collaboration across different functions.
- Excellent workload prioritization within a dynamic, timeline-driven, culturally diverse organization.
- Advanced organizational, planning, and prioritization skills with effective problem-solving and decision-making abilities.
- Excellent communication (written and oral), negotiation, and influencing skills.
- Ability to build and maintain efficient professional relationships with partners and stakeholders.
- Experience operating in cross-cultural and complex organizational matrices.
- Self-driven with effective time management skills.

**Why Choose Us**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SA

\#LI-SA

\#vhd

\#LI-Hybrid

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Global Safety Officer

**Job title:** Global Safety Officer

**Location:** Cambridge, MA / Morristown, NJ

**About the job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

In this role you will be active in five main areas

**Internal & External Safety Expert**

- Provide PV and risk management expertise to internal and external customers
- Safety expert for product
- Maintain knowledge of product, product environment, and recent literature
- Maintain PV expertise, and understanding of international safety regulations and guidelines
- Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
- Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
- Provide strategic and proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements

**Signal Detection & Assessment**

- Responsible for signal detection and analysis
- Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
- Identify and implement proactive safety analysis strategies to further define the safety profile
- Lead aggregate safety data review activities and coordinate safety surveillance activities

**Risk Assessment/Risk Management/Benefit-Risk Assessment**

- Provide proactive risk assessment
- Co-lead benefit-risk assessment with other relevant functions
- Develop risk management strategies and plans and monitor effectiveness
- Collaborate with Center of Excellence for Risk Management and Safety Epidemiology

**Submission Activities**

- Represent safety position in cross functional submission teams
- Ensure generation, consistency, and quality of safety sections in submission documents
- Write responses or contributions to health authorities questions
- Support preparation and conduct of Advisory Committee meetings

**Report Writing**

- Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
- Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products

**About You**

**Qualifications/Education & Work Experience:**

- M.D. Degree or equivalent
- For MD, Board Certified/Board eligible, or equivalent, is preferred
- Minimum 3 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered.Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience

**Competencies:**

- Excellent clinical judgment
- Capability to synthesize and critically analyse data from multiple sources
- Ability to communicate complex clinical issues and analysis orally and in writing
- Able to develop and document sound risk assessment
- Demonstrates initiative and capacity to work under pressure
- Demonstrates leadership within cross-functional team environment
- Excellent teamwork and interpersonal skills are required
- Fluent in English (written and spoken)

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Global Safety Officer, I&I

**Job title:** Global Safety Officer, I&I

**Location:** Cambridge, MA / Morristown, NJ

**About the Job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities:**

**Internal & External Safety Expert:**

- Provide PV and risk management expertise to internal and external customers
- Safety expert for product
- Maintain knowledge of product, product environment, and recent literature
- Maintain PV expertise, and understanding of international safety regulations and guidelines
- Lead cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs)
- Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
- Provide strategic and proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements

**Impact:**

- Ongoing assessment of the safety status of the product
- Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling
- Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners
- Management of product safety alerts
- Ensuring the GPE position is well articulated to and understood by its internal and external customers
- Establishment of credibility of GSO function and of GPE

**Signal Detection and Assessment:**

- Responsible for signal detection and analysis
- Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group
- Identify and implement proactive safety analysis strategies to further define the safety profile.
- Lead aggregate safety data review activities and coordinate safety surveillance activities

**Risk Assessment/Risk Management/ Benefit-Risk Assessment:**

- Provide proactive risk assessment
- Co-lead benefit-risk assessment with other relevant functions
- Develop risk management strategies and plans and monitor effectiveness
- Collaborate with Center of Excellence for Risk Management and Safety Epidemiology

**Submission Activities:**

- Represent safety position in cross functional submission teams
- Ensure generation, consistency, and quality of safety sections in submission documents
- Write responses or contributions to health authorities questions
- Support preparation and conduct of Advisory Committee meetings

**Report Writing:**

- Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report
- Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.

**About You**

**Knowledge and Skills:**

- Excellent clinical judgment
- Capability to synthesize and critically analyze data from multiple sources
- Ability to communicate complex clinical issues and analysis orally and in writing
- Able to develop and document sound risk assessment
- Demonstrates initiative and capacity to work under pressure
- Demonstrates leadership within cross-functional team environment
- Excellent teamwork and interpersonal skills are required
- Fluent in English (written and spoken).

**Formal Education And Experience Required:**

- M.D. Degree or equivalent.
- For MD, Board Certified/Board eligible, or equivalent, is preferred
- For M.D., minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

**Why Choose Us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

The salary range for this position is:

$178,500.00 - $297,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the [LINK](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>).

\#GD-SA

\#LI-SA

\#LI-Hybrid

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Daiichi Sankyo

Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations &

Job Description

Job Title: Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance

Job Requisition ID: 2057

Posting Start Date: 8/19/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

Lead the Global Clinical Operations Team by providing strategic and tactical guidance and support for clinical staff with high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Deliver Evidence Generation projects in preparation for launch activities in Oncology Business unit countries as well in other Regions. Responsible for all primary data generation in GMA studies (i.e. Company Initiated Interventional Studies (CIS), Non-interventional Studies (NIS), Expanded Access Programs (EAP), Investigator Initiated studies (IIS) and External Collaborative Study Research projects (ECSR)). Ensure successful execution, timelines and clinical milestones. Accountable for overall Clinical Operation performance against key metrics Accountable for all budget related management

**Responsibilities**

- Clinical Operations Study/ Program Management
  Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
  Ensure preparation and execution and reporting of all clinical trial activities, ensuring adherence to timelines, budgets, quality plans, and relevant ICH/GCP Guidelines
  Provide strategic input into the development of the protocols to ensure designs are implementable to efficiently achieve the objectives.
  Provide strategic input in the development of CRFs, ICFs, Monitoring Plans, final reports and publications as applicable.
  Develop, implement and ensure adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.
  Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, safety updates/ notifications etc
  Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership
  Have a robust management plan in place before starting a study/ program to ensure optimal control and monitoring, to minimize risks and ensure timely response to treating physicians
  Investigator Initiated Studies (IIS) and External Collaborative Research Studies (ECSR)
  Provide oversight of the overall IIS process related to third-party Investigator Initiated Studies IIS and External Collaborative Research Studies (ECSR) as per the Standard Operating Procedure (SOP)(regional review, Global review, tracking of milestones as per contract)
  Ensure the IIS process is revisited regularly to adhere to the (SOP) and identify and remediate/correct any gaps on a timely manner to ensure robust preparation and review by the Global IIS committee as well as proper documentation of decisions and document repository
  Oversight of the IIS system for management of IIS review and approvals (IMPACT)

- Oversight of Study Teams (ST) for GMA Medical Programs
  Develop an overarching project management plan
  Lead (or delegate to a team member) and manage the global multidisciplinary team to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance; chair ST meetings, report study progress and issues with their resolution plan; lead trial level interactions with relevant functions including Drug Supply Management and local medical organizations
  Anticipate and efficiently mitigate risks

**Responsibilities Continued**

Collaborate with cross-functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, Regulatory Affairs, and Quality Assurance, HEOR if applicable). Lead team to develop functional center of excellence in clinical trial execution by identifying and implementing best-in-industry practices. Accountable for overall management of clinical trial team when applicable. Ensure clinical operations teams regulatory and Good Clinical Practice (GCP) compliance. Comply with applicable regulations, GCP and corporate policies and procedures

- Vendor/CRO/Supplier Management
  Develop clinical outsourcing specifications incorporation with respective line functions to facilitate bid templates and selection of CROs; provide strong oversight of CROs.
  Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level
  Identify and evaluate potential clinical partners which may include CROs, investigators, and other vendors necessary to execute the medical program.
  Ensure selection of experienced CRO; and internal resources for proper oversight and management internally
- Managerial responsibilities
  Establish annual objectives for the Clinical Operation group according to GMA priorities and individual development needs. Participate in the hiring, on-boarding, training and mentoring of new staff. Identify individual training needs to foster high levels of performance, support career development through quality development plans and proactively manage performance issues. Manage all budgets, contracts, agreements, vendor payments related to clinical trial programs in an effective and transparent manner. Manage and report on study budgets to include addressing variances, payments and revisions, as applicable.
- Regional Support
  Work with the Regional Teams to ensure concepts and protocols are reviewed at the GMAT level with documented minutes and actions
  Ensure synopsis and protocols are reviewed at the PRG. Liaise with the Regional Operation manager to ensure alignment on the proper infrastructure to put in place as well as the expertise of the CRO. Ensure regular updates provided to GMAT on trial metrics and data. Establish strong partnership with Regional Operational managers to drive operational excellence in regions and countries for medical affairs clinical activities.
- GMA LT responsibility
  Member of the GMA LT Oncology. Coordinate with the Global Medical Affairs Oncology Leadership team (GMA LT) to ensure efficient and transparent allocation of Clinical operation resources, assignment of activities in support of program/trial deliverables and individual development needs. Develop a hiring plan for GMA and oversee the hiring process.
  Accountable for keeping a resource model adapted to GMA to optimize resource allocation and reallocation according to growth of portfolio and change in strategies
  Align across franchise to ensure consistency in execution for all activities (CIS, EAP, IIS management). Interface optimally with QA, legal/compliance, Clinical Supply Organization, R&D CE, to seek input or feedback or alignment on a timely manner when needed
- Process/Policies
  Develop and implement process standards and tools to achieve excellence in trial operations and management. In collaboration key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance within GMA across compounds and projects. Serve as knowledge source for clinical operations staff on processes related to trial deliverables and coordinate knowledge sharing. Author/reviewer for clinical SOPs. Support the development of clinical operations related Corrective and Preventative Action (CAPA) plans for issues of non-compliance if applicable

**Qualifications**

**Education Qualifications**

Bachelor's Degree required; degree in life science/healthcare preferred. Advanced degree preferred.

**Experience Qualifications**

10 or More Years of related overall experience required

4 or More Years of pharmaceutical clinical research experience preferred

4 or More Years people management and development experience, this may include management in a matrix environment. Global people management required

Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs preferred

mindset of putting the patient first, as well as have a values-driven leadership style where integrity drive all behaviors, decisions, and actions preferred

Strong management, interpersonal and problem solving skills preferred

Extensive knowledge of clinical development process, regulatory requirements and GCP. preferred

Proven capabilities in clinical operations process improvements preferred

Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation preferred

Understand the importance to involve and include key stakeholders on a timely manner to ensure transparency, awareness in order to optimize the decision making process and timelines of implementation preferred

Medical/scientific knowledge of Oncology and/or Haematology preferred

Forward thinker looking to advance the mission and values of the company preferred

Demonstrated vendor and project management experience preferred

Ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions preferred

Proven ability to work with minimal supervision in a cross-functional matrix environment preferred

Demonstrate the ability to lead and influence others and work successfully in a matrix environment with internal and external team members preferred

highly organized and detail-oriented preferred

**Travel Requirements**

Ability to travel up to 20% of the time. Standard office based physical demands, minimal travel.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$271,500.00 - USD$452,500.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

New Jersey

Senior Director Clinical Safety MD

Job Description

Job Title: Senior Director Clinical Safety MD

Job Requisition ID: 1964

Posting Start Date: 8/4/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).

**Responsibilities**

Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally. Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact. Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products. Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time. Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).

**Qualifications**

**Education Qualifications**

MD Board certification or eligibility required

**Experience Qualifications**

6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology is required Experience in clinical development, submission and post marketing, is strongly recommended.

**Physical Requirements**

N/A N/A% of the time.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$280,350.00 - USD$467,250.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Senior Director, Clinical Safety MD

Job Description

Job Title: Senior Director, Clinical Safety MD

Job Requisition ID: 1041

Posting Start Date: 5/11/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).

**Job Description**

**Responsibilities**

- Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
- Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact.
- Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals.
- Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
- Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
- Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
- Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).

**Qualifications**

**Education Qualifications**

MD. Board certification or eligibility required

**Experience Qualifications**

6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$280,350.00 - USD$467,250.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Director, Global Labeling Strategist

Job Description

Job Title: Director, Global Labeling Strategist

Job Requisition ID: 2166

Posting Start Date: 9/10/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

**Job Summary**

The Director, Global Labeling, Labeling Strategy, plays a crucial leadership role in Global Labeling by coordinating and managing labeling activities for a major product with multiple indications. This role oversees the development, maintenance, and implementation of labeling content for an existing product under a global alliance partnership. The position could also be responsible for new products under development. The position leads activities of Global Labeling Strategists (GLSs) and steps in as a GLS when needed. Acting as a subject matter expert, this role guides labeling strategy for Global Product Teams and its functions.

Key responsibilities include driving the creation and maintenance of the CCDS, US, and EU labeling, as well as overseeing the review of country-specific labeling deviations for Daiichi Sankyo products to ensure compliance with Health Authority regulations, internal procedures, and business goals. The position works closely with Labeling Operations & Compliance, cross-functional labeling working teams, alliance partners, and regulatory agencies to develop effective labeling strategies and maintain ongoing compliance.

**Job Description**

**Responsibilities**

- Labeling Leadership: Lead the development and execution of global regulatory labeling strategies for assigned portfolio, ensuring alignment with organizational priorities and alliance partner needs as appropriate. Be the Labeling Strategy subject matter expert to the Global Product Team(s) (GPT). Serve as a role model for less experienced members of GRA labeling,
- Labeling Content Management: Manage the preparation, review, and approval of labeling content (including target labeling) for new product submissions, variations, and updates for marketed products, ensuring accuracy, consistency, and regulatory compliance. Oversee the management of company core data sheet(s), patient labeling, and product labeling for the US and EU, and support global implementation as needed. Support China and Japan through global labeling governance process as needed.
- Labeling Negotiations: Strategize and plan for health authority negotiations, lead cross-functional labeling working teams through negotiations while ensuring alignment with senior management.
- Cross-functional Collaboration: Serve as the regulatory labeling lead on cross-functional teams, working closely with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial to enable timely achievement of labeling milestones and project objectives. Build cross-functional and cross-regional relationships
- Labeling Governance Support: Contribute subject matter expertise to labeling governance committees and facilitate feedback collection and resolution prior to committee review. Provide expert feedback on labeling strategy on all DS development products prior to governance.
- Alliance Partnership Coordination: Key point of contact for alliance partner on assigned product(s). Ensure mutually agreed ways of working are aligned with DS processes and alliance agreements. Collaborate with alliance partners to address regulatory labeling matters, ensuring transparent communication and alignment on labeling strategies and deliverables.

**Responsibilities Continued**

- Compliance Monitoring: Track and interpret changes in global regulatory requirements related to product labeling, ensuring all activities remain current with applicable regulations, guidelines, internal and industry standards. Ensure compliance with internal processes for record keeping and tracking of labeling milestones. Collaborating with Global Labeling Operations and Compliance leads to produce high quality labeling documentation.
- Process Improvement: Identify and implement process enhancements to increase labeling efficiency, quality, and compliance, leveraging industry best practices and technological advancements. Contribute to/Lead process improvement initiatives as needed.
- Actively support Global Labeling’s strategic objectives by fostering collaboration, sharing expertise and driving high standards of performance through feedback, aligning priorities, mentoring labeling strategists, facilitating effective communication between team members and leadership.

**Qualifications**

**Education Requirements**

- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field required.
- Advanced degree (Master’s, PharmD, or PhD) in a relevant scientific discipline preferred.

**Experience Requirements**

- 10 or more year pharmaceutical industry experience required
- 4 or more years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required
- Experience with country labeling a plus (outside the US/EU) preferred
- Track record of leadership in global regulatory labeling , preferably for oncology products.
- Proven experience with global regulatory agencies (e.g., FDA, EMA, PMDA) and international product labeling requirements
- Strong verbal and written communication skills, with the ability to interact effectively with internal and external stakeholders.
- Experience working within global alliance partnerships is a plus.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

**Salary Range:**

USD$193,040.00 - USD$289,560.00

[Download Our Benefits Summary PDF](<https://dmscdn.successfactors.com/886bee122c7aa5b9923a39bc71a2674d43c27f80448c122562765b1812b407af/static_content/1659df144cbb4da8ae09/2026_BenefitsHighlightsForPublicPosting.pdf>)

Professionals

Dyne Therapeutics

Associate Director, Clinical Operations Study Lead

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Clinical Operations Study Lead ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies ad SOPs.

This individual may be responsible for one highly complex or multiple medium complexity clinical studies. This role is expected to require up to 20% travel, including international travel.

This role is based in Waltham, MA.

**Primary Responsibilities Include:**

- Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
- Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP
- Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
- Support the selection, oversight, and management of CROs and other vendors
- Perform and document sponsor oversight activities for outsourced trial activities, including oversight of CRO performance, KPIs, KRIs, protocol deviations, quality events, risks, and CAPAs to ensure compliance with regulatory expectations and company standards.
- Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
- Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track
- Lead cross-functional teams and manage study team in partnership with the CRO
- Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
- Responsible for planning and conducting investigator meetings together with the CRO
- Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
- Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
- Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
- Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
- Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
- Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready”
- Prepare high-quality reports (financial, project, etc.) for senior management on program status and issues as required
- Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams
- Contribute to clinical operations functional initiatives, including process improvement, inspection readiness, department standards, lessons learned, and implementation of operational best practices.

**Education and Skills Requirements:**

- Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable
- 8+ years of clinical trial management experience in conducting Phase I-III global clinical trials, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline and budget expectations. Prior site and/or monitoring experience is advantageous
- Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred. Experience with rare disease and/or pediatric trials also preferred
- Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws
- Understand clinical study budgets, accruals and forecasting
- Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
- Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships
- Experience in vendor selection and overseeing studies being managed by a CRO
- Ability to successfully engage and work collaboratively with clinical operations team members/colleagues and other functions, including Medical Affairs and Commercial, as necessary
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
- Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality)
- Excellent communication skills

\#LI-Onsite

MA Pay Range

$165,000 - $200,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Associate Director, Talent Acquisition Operations & Programs

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Associate Director, Talent Acquisition Operations & Programs leads the systems, programs, processes, and operational infrastructure that enable Dyne to hire efficiently, consistently, and compliantly as the organization grows. This role builds scalable recruiting practices, improves the experience for candidates, recruiters, hiring managers, and interview teams, and strengthens TA technology and reporting, data, governance, and operational ways of working. The Associate Director partners closely with Talent Acquisition, Human Resources, Finance, Legal, IT, Communications, and business leaders to translate hiring priorities into effective execution, drive process improvement, and support a high-quality, data-informed recruiting experience across Dyne.

This position is based in Waltham, MA.

**Primary Responsibilities include:**

*Talent Acquisition Operations, Systems & Infrastructure*

- Develop, execute, and evolve the talent acquisition operations strategy to support organizational growth, hiring quality, operational consistency, and scalability
- Own end-to-end TA operations infrastructure from requisition creation through candidate handoff to onboarding, ensuring workflows, approvals, templates, interview stages, documentation, and system processes are clear, efficient, and consistently followed
- Own and optimize the Talent Acquisition technology ecosystem, including applicant tracking systems, workflow configuration, integrations, reporting capabilities, data integrity, user support, and ongoing enhancements
- Serve as the primary operational partner for TA system administration and enhancements, partnering with HRIS, IT, HR Operations, and vendors to ensure data flows, integrations, automation, and reporting support TA execution and decision-making
- Partner with HR leadership to develop and implement a TA technology and automation roadmap, including AI-enabled capabilities that improve efficiency and scalability, candidate experience, hiring team enablement, and operational quality
- Design, implement and continuously improve scalable recruiting systems, processes, governance models, and operating frameworks, and standard operating procedures that support consistent hiring practices across functions and geographies
- Support management of Talent Acquisition vendors, contracts, budgets, purchase orders, invoicing, renewals, service expectations, and strategic partnerships
- Ensure recruiting practices, systems, workflows, and documentation comply with applicable laws, regulations, company policies, audit standards, and data integrity expectations

*Talent Programs, Candidate Experience & Process Excellence*

- Own and evolve Dyne’s core Talent Acquisition programs, including candidate experience, structured interviewing and assessment, hiring manager and hiring team enablement, recruiter enablement, referral programs, early talent programs, and extended workforce-related TA processes
- Translate hiring strategy and business needs into scalable, repeatable programs that improve consistency, quality, speed, candidate experience, and stakeholder accountability
- Design, implement, and continuously improve end-to-end recruiting, interview, assessment, offer, and candidate experience programs
- Establish and maintain candidate and internal stakeholder experience standards, communications, templates, interview materials, hiring team resources, and best practices
- Partner with TA leadership, recruiters, coordinators, HRBPs, HR Operations and hiring managers to identify gaps, friction points, and process pain points, and implement practical solutions that simplify and scale the recruiting process
- Lead talent acquisition programs, including interview experience, employer branding support, recruiter enablement, referral programs, and early talent programs, including internships and co-ops
- Drive adoption and accountability for TA programs across recruiters, coordinators, hiring managers, interview teams, and cross-functional partners
- Drive consistency in job descriptions through clear governance, standardized templates, role intake expectations, leveling partnership, and a structured review process
- Develop compliant, audit-ready recruiting processes, including dispositioning practices, documentation standards, and regulatory requirements
- Identify, prioritize, and lead TA process optimization and operational excellence initiatives opportunities to improve efficiency, effectiveness, scalability, and user experience across the recruiting lifecycle

*Data, Analytics & Operational Reporting*

- Establish, maintain, and continuously improve Talent Acquisition dashboards, reports, and metrics that enable operational transparency, accountability, and informed decision-making
- Develop executive-level reporting and translate recruiting data into actionable insights, recommendations, risks, trends, and business outcomes
- Monitor recruiting performance indicators, service levels, capacity, pipeline health, time-to-fill, aging requisitions, candidate and hiring team experience, process adherence, and other operational metrics to support accountability and continuous improvement
- Ensure TA data accuracy, accessibility, governance, and integrity across systems, reports, dashboards, and recurring leadership updates
- Partner with TA leadership and HR to support hiring prioritization and operational readiness through clear TA insights and reporting
- Leverage data to identify trends, risks, opportunities, and process improvement recommendations across TA operations

*Leadership & Cross-Functional Partnership*

- Provide guidance, operational support, training, and service standards for Talent Acquisition Coordinators and other TA operational resources
- Establish clear workflows, SLAs, quality expectations, escalation paths, and accountability to support consistent, and high-quality execution across the recruiting process
- Develop tools, training, process documentation, and enablement resources that help recruiters, coordinators, hiring managers, and interview teams execute effectively
- Partner closely with HR Operations & Onboarding, HR Business Partners, Finance, Legal, IT, Communications, and business leaders to ensure seamless execution across the candidate-to-employee lifecycle
- Drive strategic Talent Acquisition initiatives and cross-functional projects that enhance organizational effectiveness and support Dyne’s continued growth
- Act as a change leader for new TA programs, tools, workflows, and processes, driving adoption through clear communication, stakeholder engagement, training, and practical implementation support
- Foster a culture of operational excellence, innovation, accountability, collaboration, and continuous improvement

**Education and Skills Requirements:**

- Bachelor’s degree in Human Resources, Business Administration, Organizational Development, or a related field preferred
- 8+ years of related experience in Talent Acquisition, Recruiting Operations, Talent Programs, Human Resources Operations, or a related discipline
- Experience leading programs, projects, workstreams, or cross-functional initiatives in a Talent Acquisition or HR environment
- Experience providing operational guidance, training, and support to recruiting coordination or TA operations teams preferred
- Experience in biotechnology, life sciences, or a similarly fast-paced, high-growth environment preferred
- Deep hands-on expertise with applicant tracking systems, recruiting technologies, system integrations, reporting tools, and talent acquisition analytics; Greenhouse experience strongly preferred
- Demonstrated systems-oriented mindset with experience leveraging technology, automation, reporting tools, and AI-enabled solutions to improve operational performance
- Strong knowledge of recruiting compliance requirements, hiring processes, audit readiness, documentation standards, and dispositioning best practices
- Experience designing, implementing, and scaling recruiting processes, programs, and governance models
- Proven ability to lead complex projects, manage competing priorities, and drive outcomes through influence and collaboration
- Strong analytical, problem-solving, and business acumen with the ability to synthesize data into actionable recommendations
- Excellent stakeholder management, communication, and change management skills across multiple organizational levels
- Demonstrated ability to build strong cross-functional partnerships and align stakeholders around shared goals
- Experience developing dashboards, operational reports, and executive-level TA reporting
- Embodies Dyne’s values through accountability, collaboration, purpose-driven leadership, and continuous improvement

\#LI-Onsite

MA Pay Range

$175,000 - $200,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Director, People Operations

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director, People Operations is responsible for leading and executing Dyne’s HR Operations strategy, operating model, and roadmap across onboarding, HRIS administration, benefits coordination, HR compliance, vendor management, reporting and analytics, service delivery, and process optimization. This hands-on role balances day-to-day HR operational execution with strategic ownership of scalable, data informed processes that improve efficiency, consistency, compliance, and the employee experience. The Director, People Operations serves as a trusted partner to HR leadership, managers, employees, and cross-functional stakeholders, ensuring that people processes are practical, data-informed, compliant, and aligned with Dyne’s culture, values, and business priorities. This role will provide leadership across HR systems, employee lifecycle operations, onboarding, vendor governance, service delivery, analytics, and process transformation, helping to build a scalable People Operations function that supports Dyne’s continued growth and commercialization readiness.

This role is office-based in Waltham, MA.

**Primary Responsibilities include:**

- Lead the strategy and operating priorities for core People operations while directly conducting and supporting day-to-day activities across onboarding, HRIS administration, benefits coordination, employee life-cycle administration, reporting, vendor management, and compliance
- Lead the operational execution of annual and recurring HR programs, including compensation cycles, performance management, talent processes, employee lifecycle events, and related communications, timelines, tools, data preparation, reporting, and issue resolution in close partnership with HR Business Partners, Total Rewards, Talent Acquisition, Finance, Legal, and HR leadership
- Execute and manage day-to-day HR operations tasks as needed, including responding to employee and manager inquiries, resolving operational issues, ensuring accurate employee data, coordinating process steps, and ensuring timely completion of recurring HR operational activities including benefit audits, employee onboarding, and compliance-driven reporting
- Lead and support the People Operations Team with New Employee Orientation, including attending and presenting at orientation sessions, providing relevant onboarding details to new hires and fielding questions from new hires, managers, and hiring teams
- Provide strategic ownership and governance for ADP Workforce Now and related HR technology platforms configuration, ensuring data integrity, scalable workflows, effective integrations, automation, and reliable reporting
- Lead the strategy, design, governance, and continuous improvement of Dyne’s onboarding experience, ensuring programs, systems, and manager enablement support a consistent, engaging, and values-aligned new hire experience
- Serve as a functional expert for complex HR operational inquiries, providing practical guidance to employees, managers, HR partners, and leaders on policies, processes, systems, and service delivery expectations
- Develop, govern, and continuously improve scalable HR service delivery processes, including inquiry intake, knowledge resources, service expectations, issue resolution, and operational metrics that improve responsiveness, consistency, accountability, and employee experience
- Serve as a key partner and stakeholder in developing Dyne’s HR IT & Technology Roadmap, bringing insights and perspectives into how Dyne’s HR technology evolves over time, including the review, governance, and appropriate use of AI-enabled tools to improve efficiency, decision support, service delivery, data quality, and enhance the employee experience
- Establish governance for HR documentation, process maps, standard operating procedures, decision rights, and process ownership to enable consistency, efficiency, accountability, and adoption across the organization
- Lead HR operational compliance practices related to employment documentation, recordkeeping, employee data, audits, and operational controls required reporting, privacy, and policy administration in partnership with Legal, Compliance, Payroll/Finance, and HR leadership
- Partner with Talent Acquisition, IT, HR Business Partners, Payroll/Finance, Procurement, Facilities, Legal, and external vendors to define scalable employee lifecycle processes, resolve operational interdependencies, and improve cross-functional execution
- Oversee key HR vendor relationships, Service Level Agreements, contracts, purchase orders, invoicing, renewals, vendor performance, and operational spend, ensuring services, costs, and timelines align with business needs and procurement policies
- Define, prioritize, and lead the HR operations automation and process transformation initiatives, reducing manual work, strengthening controls, improving scalability, and enabling the HR team to balance daily execution with more strategic work
- Contribute to HR policy strategy, development, implementation, and adoption, ensuring policies and related processes are practical, scalable, aligned with Dyne’s culture, and compliant with applicable laws and regulations
- Lead HR operations reporting, dashboards, and operational insights to support leadership decision-making, compliance, workforce planning, service delivery effectiveness, and continuous improvement
- Manage immigration-related processes, documentation, tracking, vendor coordination, and internal stakeholder communication in partnership with external counsel and HR leadership
- Provide strategic and operational leadership for benefits administration activities, including employee support, vendor coordination, data accuracy, escalations, annual processes, and process improvements
- Lead, coach, and develop People Operations team members or functional workstream owners, setting priorities, clarifying accountability, supporting professional growth, and ensuring high-quality execution across operational priorities

**Education and Skills Requirements:**

- Bachelor’s degree in Human Resources, Business Administration, or a related field; advanced degree or HR certification preferred
- 10+ years of progressive HR operations, people operations, HR shared services experience, or related HR experience preferably within biotech, pharmaceutical, life sciences, or high-growth environments, including experience in hands-on operational execution as well as strategic process leadership
- Deep experience leading HRIS, ATS, HR technology, automation, reporting, and data governance initiatives; experience with ADP Workforce Now and Greenhouse ATS strongly preferred
- Experience evaluating, implementing, and governing AI-enabled HR technology solutions where appropriate, with attention to data privacy, compliance, bias mitigation, change management, and practical adoption by HR teams and people managers
- Demonstrated ability to operate as both a strategic leader and hands-on executor in a lean, fast-paced, and evolving organization
- Demonstrated experience setting strategy and scaling onboarding, employee lifecycle, HR operations, service delivery, and HR technology processes across a growing organization
- Strong working knowledge of HR compliance, employment documentation, employee data management, benefits administration, vendor management, recordkeeping, audit readiness, leave coordination, and immigration processes, and HR operations best practices
- Proven ability to lead complex cross-functional initiatives, influence senior stakeholders, manage change, and drive adoption of new processes, systems, governance models, and ways of working
- Strong analytical and business judgment with the ability to translate HR data, service delivery metrics, operational insights, and workforce trends into recommendations, dashboards, and executive-ready narratives
- Excellent communication, judgment, discretion, and relationship-building skills, with the ability to advise employees, managers, vendors, senior leaders, and cross-functional stakeholders
- Experience leading people, functional workstreams, or cross-functional teams, with the ability to set expectations, build capability, and drive accountability through others
- Demonstrated strategic thinking, curiosity, continuous improvement mindset, and ability to identify opportunities for automation, simplification, operational excellence, and long-term scalability
- Resourceful, proactive, and solutions-oriented, with a strong sense of ownership, urgency, confidentiality, accountability, and follow-through

\#LI-Onsite

MA Pay Range

$215,000 - $235,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Senior Director, Business Strategy & Operations - Office of the CCO

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

As Dyne advances toward commercialization, we are seeking a Senior *Director, Business Strategy & Operations – Office of the CCO* to work at the center of the Commercial organization and help shape how it sets priorities, makes decisions, and executes.

This role reports directly to the Chief Commercial Officer (CCO) and works in close daily partnership with the Commercial Leadership Team. Working directly with the CCO, this leader will serve as a trusted strategic thought partner and force multiplier to the CCO and Commercial Leadership Team. The role will help frame and resolve the most important strategic, organizational, and operational questions facing Commercial, lead high-priority initiatives, and ensure critical decisions translate into coordinated action.

This is a broad, highly visible role for a leader who combines strategic rigor with strong execution. The successful candidate will be comfortable tackling ambiguous problems, influencing senior stakeholders without formal authority, simplifying complexity, and moving fluidly between enterprise-level questions and hands-on delivery.

The role offers the opportunity to help build a Commercial organization at a pivotal stage in Dyne's evolution, with direct exposure to the CCO, Commercial Leadership Team, Executive Committee, and Board.

This is a full-time position based in Waltham, MA.

**Primary Responsibilities Include:**

*Strategic Partnership to the CCO:*

- Serve as a trusted strategic advisor to the CCO, helping identify, frame, and resolve the highest-priority issues facing the Commercial organization.

- Partner with the CCO and Commercial Leadership Team to assess priorities and trade-offs, prepare key decisions, and translate those decisions into clear action.

- Develop clear, decision-oriented insights and recommendations for the CCO and Commercial Leadership Team.

*Strategic & Enterprise Initiatives:*

- Lead high-priority strategic and cross-functional initiatives on behalf of the CCO, particularly where the stakes are high, ownership is unclear, or coordination spans multiple functions.

- Structure complex and ambiguous business problems, establish decision frameworks and workplans, and drive initiatives from problem definition through resolution and execution.

*Commercial Leadership & Operating Model:*

- Help shape and evolve the Commercial operating model as Dyne builds toward launch and future growth.

- Establish an effective leadership operating rhythm, including strategic planning, governance, business reviews, and decision-making processes.

*Executive & Organizational Effectiveness:*

- Develop Executive- and Board-level materials that distill complex issues into clear strategic narratives, choices, and recommendations.

- Help build a high-performing Commercial leadership culture characterized by clarity, collaboration, accountability, and effective decision-making.

- Support organizational planning and capability-building as the Commercial organization grows and evolves.

**Education and Skills Requirements:**

- 15+ years of experience, including demonstrated experience operating as a strategic advisor to C-suite executives.
- Bachelor’s degree required; advanced degree (MBA, PharmD, PhD) preferred.
- Strategy consulting background within life sciences preferred.
- Exceptional strategic problem-solving and analytical capabilities, with a demonstrated ability to structure ambiguous questions and translate insights into actionable recommendations.
- Proven ability to lead cross-functional initiatives and influence effectively without formal authority.
- Exceptional written and verbal communication skills, including the ability to simplify complexity for senior audiences.
- Strong judgment and the maturity to navigate complex, sensitive, and often confidential business issues.
- Commercial strategy, rare disease, or product launch experience.
- Experience supporting an organization through late-stage development, significant growth, organizational transformation, or commercialization.
- Strong prioritization, organizational awareness, and follow-through.
- Highly self-directed and comfortable operating in a dynamic environment with evolving priorities.

\#LI-Onsite

MA Pay Range

$233,000 - $280,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Director, Drug Safety & Pharmacovigilance Scientist

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne’s development programs. This role characterizes and communicates the safety profiles of investigational therapies, contributes to regulatory safety strategies and submissions, and ensures pharmacovigilance activities are conducted in compliance with applicable global regulations and company procedures. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making. The role applies expert scientific judgment to complex safety data, drives continuous improvement of pharmacovigilance processes, and contributes to a culture focused on patient safety, scientific excellence, and operational rigor.

This position is based in Waltham, MA.

**Primary Responsibilities Include:**

*Safety Surveillance, Signal Detection & Risk Management*

- Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, individual case safety reports (ICSRs), nonclinical studies, scientific literature, and other relevant sources.
- Support medical and scientific review of ICSRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.
- Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.

*Safety Reporting, Documentation & Regulatory Support*

- Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical study reports, integrated safety summaries, briefing documents, and regulatory submissions.
- Prepare and present safety data, analyses, recommendations, and risk management strategies to cross-functional teams and governance committees.
- Maintain complete, accurate, and inspection-ready documentation of safety surveillance activities, safety decisions, and associated deliverables.

*Cross-Functional Leadership & Safety Governance*

- Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external vendors to integrate safety considerations into study conduct and program strategy.
- Participate in safety governance forums and cross-functional program teams, providing scientific insight and recommendations to support decision-making.
- Influence safety-related discussions across development programs through clear communication of complex safety data and benefit-risk considerations.
- Foster a culture of collaboration, accountability, scientific excellence, and continuous improvement across Drug Safety & Pharmacovigilance and the broader organization.

*Pharmacovigilance Operations, Compliance & Continuous Improvement*

- Develop, maintain, and enhance pharmacovigilance SOPs, work instructions, templates, and processes in alignment with global regulatory requirements and industry best practices.
- Provide pharmacovigilance training and guidance to internal colleagues and cross-functional partners on safety surveillance, reporting requirements, documentation practices, and inspection readiness.
- Support pharmacovigilance vendor oversight activities, including review of deliverables, quality assessments, issue escalation, and process improvements.
- Monitor evolving pharmacovigilance regulations, guidance, and industry standards and implement appropriate process enhancements to ensure continued compliance and operational effectiveness

**Education and Skills Requirements:**

- Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline required; MD, PharmD, PhD, or equivalent advanced degree preferred.
- 10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience.
- Demonstrated expertise in safety surveillance, signal detection, signal evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage development programs.
- Experience authoring or contributing to DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related sections of clinical or regulatory documents.
- Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements.
- Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations.
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and pharmacovigilance vendor oversight practices.
- Demonstrated ability to apply sound scientific and medical judgment to complex safety information and communicate implications effectively to diverse stakeholders.
- Strong analytical, problem-solving, technical writing, presentation, and project management skills.
- Ability to manage multiple priorities and deliver high-quality work in a dynamic, fast-paced environment.
- Proven success collaborating within matrixed organizations and influencing stakeholders without direct authority.
- Strong attention to detail, accountability, integrity, and commitment to patient safety.
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology is preferred.

\#LI-Onsite

MA Pay Range

$220,000 - $240,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*