At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®), to discover and develop innovative new medicines for patients with cancer. Working at Merus will give you the opportunity to join us in our mission of closing in on cancer. We are a global and diverse team of highly qualified professionals who care deeply about making a difference in patients’ lives. We have bold aspirations, because the need is great and the patients are waiting. Join us and make an impact.

Your role:

We are seeking an Associate Director for our electronic Trial Master File (eTMF) team. This role involves leading the eTMF team and overseeing the management of all eTMF activities, ensuring that the Trial Master File is inspection-ready at all times.

In this role you will:

As Director eTMF, you will act as the TMF Subject Matter Expert for the clinical study team and support cross-functional departments to ensure high-quality documentation.
Lead and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert.
Be responsible for the setup, management, archiving processes, and execution of Vault, including naming conventions, processes, migrations, etc.
Ensure the TMF(s) for each program are compliant and ready for inspections by auditors and regulatory authorities (TMFs with CRO partners and the internal Veeva Vault system).
Drive and enforce timelines with a sense of urgency to meet clinical trial deadlines, as well as corporate/department goals and objectives.
Lead the development of procedural documents, SOPs, etc., and oversee the creation of individual project TMF management plans and related materials.
Act as a primary point of contact for project teams for guidance, oversight, metric creation, and review, as well as a key liaison for CROs, auditors, IT, and external parties.
Review and resolve discrepancies within eTMFs, ensuring timely reporting and internal reviews.
Participate in clinical operations meetings, audits, and inspection readiness activities, ensuring smooth preparation.
Identify and implement continuous process improvements in collaboration with stakeholders.
Manage budget proposals from third parties related to eTMF activities or systems, ensuring alignment with business needs.
Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements.
Guide and provide metrics for CRO and internal TMF systems to reflect TMF status and health accurately.
Oversee access management and ensure appropriate internal and external access to the eTMF system. Be the system owner and expert for Veeva Vault at Merus.
Ensure compliance with global regulations and guidelines for TMF management, staying current with changes in industry standards.

Your Profile:

The ideal candidate will have extensive experience with Veeva Quality systems and will be responsible for training and supervising eTMF staff.

Bachelor’s degree or international equivalent in information management, library science, clinical science, or a related field.
8-10 years of TMF management experience in global clinical trials.
Experience with computerized clinical trial records management technologies, particularly Veeva systems.
4-5 years of personnel management experience, with a proven track record of mentoring and developing teams.
Strong organizational, writing, and communication skills.
Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.

Our offer

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.

Merus is seeking a Senior/Principal Biostatistician with a robust background in statistics and relevant experience in clinical trials to join our team. To be based within our dynamic biostatistics function, you will be reporting to a Senior Director of Biostatistics. This position significantly impacts our clinical development activities, including leading the statistical aspects of clinical trials from design through to analysis, ensuring the delivery of high-quality data to support our clinical development programs.

Your Role

As a Senior Biostatistician at Merus, you will be responsible for all statistical aspects of clinical trials, ensuring methodologies and analyses are robust and aligned with scientific objectives. Your role involves strategic collaboration with cross-functional teams and oversight of CROs to guarantee high-quality statistical deliverables.

Areas of responsibility:

Serve as the lead statistician for at least one study within our clinical development programs, offering strategic statistical input from trial design to analysis.
Collaborate with cross-functional teams on study design, including sample size, randomization procedures, endpoint selection, and case report form design.
Develop, oversee, and ensure the alignment of Statistical Analysis Plans (SAPs) with study objectives and regulatory compliance.
Oversee CRO deliverables, ensuring the accuracy, quality, and integrity of statistical outputs, including the production of tables, listings, and figures.
Foster collaborative relationships within the clinical department and with external vendors to maintain effective communication and project integrity.
Provide comprehensive statistical support across all phases of clinical trial and project development, including the design of clinical study reports.

Your Profile:

For this role, we seek a candidate with an advanced degree in statistics or equivalent, with relevant experience pharma, biotech or CRO. You’ll bring a deep understanding of statistical principles applied to clinical research, proficiency in statistical software (e.g., SAS, R), and a proven ability to communicate complex statistical concepts clearly. Your expertise will be instrumental in driving our research forward, with strong knowledge of statistical principles in a regulatory environment .

Requirements:

A Master’s degree in statistics or a related field, with at least 5 years of relevant experience in clinical trial analysis.
Demonstrated expertise in statistical analysis within clinical or related subjects – experience in oncology is a plus.
Familiarity with international standards (ICH, GCP, CDISC) and clinical study regulations.
Proficiency in statistical software packages (e.g., SAS, R).
Excellent communication and interpersonal skills, with the ability to translate complex statistical concepts for non-technical audiences.
Strong leadership and collaboration skills, capable of working on multiple projects simultaneously and under pressure.

Benefits

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

We are seeking a Financial Controller for our Finance & Accounting team, based in our Utrecht office. Our team, consisting of five professionals, is dedicated to managing key financial accounting responsibilities for our two entities: the Dutch N.V. and the US Inc.

In this role, you will contribute to preparing and executing detailed monthly accounting transactions, journal entries (including PO and non-PO), ensuring compliance with SOX and US GAAP in predominantly the area of R&D, Clinical and CMC accounting . You’ll provide crucial support to colleagues in both the Netherlands and the US, working closely within the team to meet stringent timelines and requirements for both the N.V. and Inc. books. This position demands a deep understanding of accounting, the ability to oversee the bigger picture, and a commitment to continuous improvement and optimization in our financial operations.

Your role

· Accounting and Transactions: Prepare and execute monthly accounting transactions, including journal entries for Preclinical, R&D, clinical accruals, drug substance/product accruals, and pre-paid expenses, ensuring detailed tracking and reconciliation on a monthly basis.

· Collaboration and Oversight: Work closely with accounting peers, internal project managers (R&D, Clinical and CMC), and other stakeholders like, critical vendors, supply chain and vendor management to align on transactions and track purchase orders (POs) and contracts.

· Review and Approval: Oversee the accuracy of financial documents, including (Pre) Clinical and CMC trackers, and approve the work of others, ensuring compliance with accounting standards.

· SOX Controls and Internal Audits: Manage and execute SOX controls, ensuring adherence to internal control guidelines, and maintain documentation for audits.

· Continuous Improvement: Lead initiatives for internal control and process improvements, aiming to enhance efficiency and accuracy in financial operations.

· Stakeholder Engagement: Engage with both internal teams and external specialists, including auditors and SOX specialists, to support financial operations and compliance.

Your profile

We seek a detail-oriented and analytical individual with a proactive approach and a strong commitment to accuracy and quality. The ideal candidate is hands-on, results-driven, and excels in planning and organization, with advanced Excel skills. You should possess excellent interpersonal and communication abilities, as recognized by your peers, and have a knack for driving improvements and achieving high output.

· Relevant education on master level in Accounting or (Business) Economics

· Experienced to work with SOX 404b compliance in a US listed public company

· Experienced with integrated audits

· You are proficient in all areas of financial accounting

· SAP experience is an advantage

· Previous work experience in biotechnology or pharmaceutical industry or audit practice is advantageous

· You are fluent in Dutch and English

· You are able to work in an international environment across time zones

Our offer

We offer a competitive salary and flexible working hours. Our talented international team works in an inspiring area of Utrecht (Utrecht Science Park) in a brand new state-of-the-art facility. We also offer an excellent pension scheme, company bonus, and 30 days’ annual holiday based on a full-time position. We care about team spirit and organize several company events each year.

Your role

Merus is seeking an Associate Director/Director, Program Management responsible for providing program management to support global clinical development plans for clinical candidates in various stages of development. This position will be reporting to the Sr. Director Program Management / Head of PMO. The individual will work closely with the Program Lead and be responsible for the planning, monitoring and execution of significant cross-functional projects and identifying operational excellence initiatives to drive efficiencies for key corporate and development milestones.

The Associate Director/Director, Program Management works cross functionally partnering with executive leadership, technical leads and subject matter experts across the development, operations, regulatory and quality functions to support advancement of the Company’s pipeline and operations.

The individual will be responsible for management and delivery of the integrated project and program plans, tracking progress against goals with GANTT charts, working cross-functionally to identify risks, opportunities and mitigations. Setting regular meeting reviews, agendas, minutes and action items to ensure robust documentation and oversight will be core to this role. This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables. The role will require proven project leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to drive key initiatives across the organization.

In this role you will:

Align programs with business objectives and organizational goals
Manage complex, high-impact global programs in a matrix environment
Support development of the Program Management Office (PMO), and consistent implementation of Program Management (PM) tools and processes across portfolio to deliver improved business performance, higher efficiency, and excellence in execution
Foster best practices in communication and alignment across the program team, functional teams, and other key stakeholders
Responsible for ensuring effective, accurate, and timely communication of project information to the leadership team and other relevant stakeholders to ensure single source of truth for the development programs
Execute and drive long-term strategic direction for programs, work closely with relevant functions to translate strategy into robust and realistic program and development plans;
Take end-to-end ownership of program outcomes, keeping in mind budget, timelines and scope
Drive alignment to develop executive-level reports to peers and senior management
Organize and facilitate cross-functional program teams. Prepare, lead, and document team meetings
Develop high-level, and detailed schedules (GANTT charts) across functional teams, build program budgets, and anticipate resource constraints or process bottlenecks
Monitor and proactively manage program sub-team deliverables, track progress against milestones, flag resource or process bottlenecks, and adjust and correct as needed
Anticipate, identify, quantify and escalate issues and risks as appropriate; propose and develop enterprise-wide mitigation strategies; maintain program risk log

Your profile

We are looking for a candidate with:

MSc or PhD with 5+ years project management experience in Biotech/Pharma, with at least 2+ years as the lead PM on a program in Ph3 trials
Background in a relevant biomedical field (e.g., molecular biology, protein chemistry, cell biology, immunology)
PMP® certification and experience with MS Project
Strong leadership, communication, and interpersonal skills, with the ability to collaborate and coordinate across all levels of the organization
Demonstrated ability to develop trusted relationships and maintain integrity
Excellent program management and organizational skills, with experience managing multiple initiatives simultaneously
Located in Boston, MA area

Our Offer

We are seeking a detail-oriented and highly organized CMC and Supply Chain Assistant to join our team. The CMC and Supply Chain Assistant will support the Chemistry, Manufacturing, and Controls (CMC) and the Supply Chain department by providing administrative assistance. The ideal candidate will have strong administrative and good communication skills.

Your role

Providing day-to-day administrative support to the team, including calendar management, meeting scheduling, and document filing.
Supporting in processing legal documents (e.g. contracts and confidentiality agreements) in Veeva Vault.
Supporting in creating and updating of Purchase Orders in SAP.
Supporting in quarterly budget reporting activities
Assisting in preparing materials for CMC-related meetings, taking minutes, and following up on action items.

Your profile

Proven experience (1-3 years) in an administrative role, preferably within the pharmaceutical, biotechnology, or life sciences industry.
Strong organizational skills and attention to detail.
Excellent written and verbal communication skills both in Dutch and in English.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Proficiency in SAP and Veeva Vault (preferred).
Ability to manage multiple tasks and deadlines in a fast-paced environment.
Strong problem-solving skills and ability to work independently and as part of a team.
Affinity with finance and legal tasks.

Why Merus?

As a member of our CMC (Chemistry, Manufacturing & Control) Team you will play an important role in the cell line, process and formulation development and drug substance and drug product manufacturing of bispecific antibody leads, and contribute to the development of groundbreaking new medicines for the treatment of cancer.

Your Role:

Supporting early and late stage development activities through scientific and technical input to plans, reports and other critical documents of (outsourced) CMC activities;
Ensuring that process development and manufacturing activities are conducted in line with good scientific principles and design, in compliance with regulatory guidelines and according to GMP, GLP and/or GDP, where applicable;
Prepare/review technical documents including development/validation/transfer protocols and reports;
Evaluating change controls and deviations related to CMC activities;
Participating in cross-functional subteams;
Providing day-to-day expertise to CMC project teams on manufacturing and other development activities, manufacturing scale-up considerations and GMP operations;
Provide input and review support for regulatory submissions;
Reporting on status and planning of CMC activities on a pro-active basis.

Your Profile:

You hold at least a Master’s degree in a relevant biomedical field, and have at least 5 years of experience in CMC in the biotech or pharma industry;
Experience in antibody development as well as antibody drug substances and/or drug product manufacturing is a strong pre;
You have good understanding of various quality systems such as GMP, GLP and GDP;
You are known for your organizational skills, accuracy and drive to continuously improve your work;
You communicate well in English, both verbal and in writing.

Why Merus?

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody technologies (Multiclonics®) to discover and develop innovative medicines for cancer patients. Working at Merus offers you the opportunity to contribute to our mission of closing in on cancer. We are a global and diverse team of dedicated professionals who are deeply committed to making a difference in patients’ lives. Join us and make an impact.

Your Role

Merus is seeking a Senior Manager Supply Chain Management to develop and implement end-to-end supply chain strategies for investigational medicinal products (IMP), comparator drugs, and necessary equipment for clinical trials and future commercial activities. You will lead a small team of subject matter experts responsible for day-to-day supply chain operations in assigned clinical trials.

Key Responsibilities

Oversee monthly demand & supply planning, managing forecasting models, and providing analyses and reports for key stakeholders.
Ensure effective inventory management across the supply network, setting targets, monitoring execution, and identifying potential imbalances.
Develop and maintain the supply planning calendar, ensuring alignment with ongoing projects.
Procure and coordinate labeling of commercial supplies in collaboration with Clinical Operations.
Lead and manage a team to ensure smooth execution of day-to-day supply chain activities.
Drive improvement initiatives to enhance supply chain capabilities within Merus.
Provide support for clinical site supply issues, including shortages, recalls, and disruptions.
Contribute to vendor selection and management for supply chain services.
Support system development and testing of supply chain-related applications, including IRT.

Your Profile

We are looking for a candidate with:

A Master’s degree in Operations, Supply Chain Management, or a related field.
10+ years of relevant experience in clinical supply chain operations, preferably in Phase 3 trials.
5+ years of experience in a leadership role.
Strong knowledge of GxP regulations.
Excellent analytical and process-oriented skills with a proactive problem-solving mindset.
Strong stakeholder management and collaboration abilities.
Fluency in English (written and verbal).
Experience with supply chain software, ERP systems, and data analysis tools.
Ability to handle multiple priorities and work in a fast-paced environment.
Willingness to travel occasionally.

Our Offer

Are you ready to join our fight against cancer?

The team:

The Clinical Operations team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I/II studies in oncology, most of them first in class compounds.

This role is US based.

The role:

As a Senior Clinical (Trials) Manager, your main tasks and responsibilities are the following:

Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under management of the Executive Director of Clinical Operations . This includes the management of Contract Research Organizations (CRO’s);
Assist in authoring protocol and related documents, development of study tools, guidelines and training materials;
Manage clinical study material, oversee vendors and other third parties and assist in the implementation plan(s); risk management, oversight management plans, data review processes, TMF review plans and execution, oversight monitoring plans and execution in addition to start-up, execution and close out of clinical trials
Global clinical trial experience in Oncology across multiple countries / regions
Manage regular thorough clinical data review (at Merus and through CROs) to ensure it occurs on time, and there is timely query resolution at CROs and clinical sites
Drive enrollment and recruitment activities and initiatives and provision of information to management team through site enrollment meetings, board slide preparation, management reports and dashboards
Support the development, management and tracking of trial budgets with the appropriate partners internally and externally;
Lead internal Operations team meetings and co-lead Clinical Trial Team (CTT) meetings with the CRO
Participate in the organization and logistics of various trial-related committees;
Manage site-related issues and procedural questions, support Executive Director & Director of Clinical Operation development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, all plans etc.
Assist with program level activities (e.g., development of clinical sections of regulatory documents such as Investigators’ Brochures, DSUR/PSUR, IND/NDA submission documents) and provide support, as needed, for HA and/or IRB/IEC inquiries.
Participation in CRA calls to assist with site follow-up, recruitment, training, protocol deviation finding resolutions, trip report review findings and overall CRA training
Review of TMF and assistance with remediation of findings along with Clinical Trial Associates (CTAs)
Manage site engagement and site relationships through communications and visits with clinical sites and cross-functional collaboration with Medical Affairs and Clinical Development
Review of Monitoring Trip Reports and provision of timely tracking of comments and suggested remediation actions to the CRO
Participation in oversight monitoring visits at clinical trial sites

Your Profile :

When hiring new employees, we look for people who will fit in well with the collaborative, rigorous, and entrepreneurial spirit of our company – a spirit that drives us to develop advanced therapies that address unmet needs in cancer treatment.

Advanced (e.g. Masters) degree or equivalent education / degree in life sciences / healthcare;
4 – 5 years of experience in clinical development;
Experience with cross-functional clinical trials, capabilities in supporting operational aspects of clinical trial related activities (planning, executing and reporting) as well as the clinical/scientific aspects;
Clinical Research Associate experience is strongly preferred and knowledge of how to conduct source data verification (SDV) and how to execute all types of monitoring visits – Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Close Out Visits (COVs)
Knowledge of GCP (Good Clinical Practice), comprehensive knowledge of clinical trial design and a good understanding of the overall drug development process; Basic knowledge of oncology, is preferred.

Our offer :

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

The Senior Director, CMC Regulatory Affairs is responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for Merus’ product candidates, from the transition from Research to Development through to product licensure.

The role will be responsible for the oversight and leading the development and implementation of CMC regulatory strategies, ensuring timely and compliant regulatory submissions, and managing the coordination of internal and external CMC regulatory activities, including those related to co-development partnerships.

Your Role:

This role requires significant expertise in regulatory affairs for biologics and/or bio-pharmaceuticals, with a deep understanding of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP. The Senior Director will work cross-functionally to ensure seamless integration of CMC regulatory strategies into development programs, enabling the timely progression of clinical trials and product development. This position is based in Utrecht, the Netherlands.

Areas of Full Responsibility:

Preparation, Review, and Approval of CMC Regulatory Filings: Lead the preparation and regulatory submission of CMC sections for regulatory filings (e.g., IMPD/IND/MAA/BLA). Ensure all submissions are accurate, compliant, and submitted in a timely manner.
Oversee CMC Regulatory Affairs Strategy: Jointly develop and implement CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
Management and Coordination of CMC Regulatory Activities: Oversee and coordinate all internal and external CMC regulatory activities related to Merus’ product candidates, including activities with external partners and contractors, and those in co-development or partnership.
Contractor Selection and Performance Monitoring: Lead the selection, evaluation, and monitoring of contractors for CMC regulatory affairs activities. Ensure contractors meet quality and performance standards, managing relationships to ensure timelines and deliverables are met.

Areas of Support:

Defining CMC Regulatory Affairs Strategy: Jointly develop the CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
Regulatory Affairs Department Creation: Work in cooperation with Clinical Regulatory Affairs to establish and support a regulatory affairs department.
Approval of CMC Regulatory Affairs Contractors: Support the approval process for contractors and vendors involved in CMC regulatory activities.

Key Activities:

Status and Planning Reporting: Regularly report on the status and planning of CMC regulatory affairs dossiers and submissions to internal stakeholders, ensuring proactive communication of timelines, milestones, and potential risks.
Manage and coach: Lead and mentor the CMC- RA team, which consistst of 3 team members, working collaboratively with to achieve goals.
Conflict Management and Escalation: Ensure any conflicts between Merus and external contractors/vendors related to CMC regulatory affairs are identified, addressed, and escalated as necessary to ensure timely resolution and project success.

Your Profile:

MSc or PhD in Life Sciences, Bio-engineering, or a related field.
At least 12 years of relevant working experience within the (bio)pharmaceutical industry or in other relevant regulatory functions, with strong expertise in CMC regulatory affairs.
Proven experience in CMC regulatory submissions (IND/IMP/MAA/BLA) for both biologic products and small molecules.
In-depth knowledge of Regulatory Affairs in the EU and US markets, with a strong understanding of relevant regulatory frameworks.
Extensive knowledge of GMP, GLP, GCP, GDP, and GRP guidelines and regulations.

Skills and Competencies:

Strong leadership and project management skills with the ability to coordinate and manage multiple cross-functional teams, including external contractors and partners.
Ability to think strategically and contribute to the development of CMC regulatory strategies.
Excellent communication and interpersonal skills, with the ability to collaborate across functions and manage regulatory relationships with external stakeholders.
Strong problem-solving and decision-making skills, with the ability to handle complex regulatory issues effectively.
Ability to work independently and manage multiple priorities in a fast-paced environment.

Why Merus?

This is a critical role in a fast-growing company that offers the opportunity to influence the regulatory strategy for innovative biologics. As a Senior Director in CMC Regulatory Affairs at Merus, you will play a key role in advancing groundbreaking therapies to treat cancer and other serious diseases. You’ll have the chance to make a significant impact on both the development of new treatments and the long-term success of the organization.

The position is based in Utrecht, the Netherlands, offering a dynamic and supportive work environment with the opportunity to collaborate on a global scale.

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