At Merus, we are clinically advancing leading-edge, targeted treatments to address the unmet needs of patients with various types of cancer. Utilizing our proprietary technology platforms, we are developing innovative multispecific antibody therapeutics, referred to as Multiclonics®. Our therapeutic candidates engage cancer antigens and harness the power of the immune system to kill tumor cells in unique and powerful ways by utilizing our proprietary technology platform and deep expertise in oncology. We are currently developing a broad pipeline of wholly owned and licensed Biclonics® drug candidates in the clinic with compelling target combinations and unique mechanisms of action.
Medical Affairs is a new function at Merus and you have an opportunity to join us on the ground floor and build a high-functioning medical affairs organization. You will be working in an international cross-functional team, supporting the development of novel bispecific antibody therapeutics. Joining Merus means joining our pursuit to develop advanced therapies that address unmet needs in cancer treatment. The successful candidate will report to the Field Medical Director.
Your Role:
The Medical Science Liaison (MSL) will be responsible for engaging with Healthcare Professionals (HCPs) in their territory through appropriate high-level scientific support for education and scientific exchange. The MSL will be a conduit for medical affairs communications and interactions for their assigned HCPs. Knowledge of oncology is required; knowledge of NGS testing and companion diagnostics is preferred.
In this role you will:
- Support study start-up though review of competitive trial landscape, precedent trials; leveraging contacts in medical community w/ prospective PIs, engagement and follow-up with potential sites
- Expand company knowledge of investigational sites, both current and new, in order to build company network to include knowledge of site capabilities and past performance
- Inform Clinical Operations when an investigator expresses an interest in becoming a site
- Develop and execute field medical affairs plan for the assigned territory level in alignment with medical affairs strategies and tactics
- Serve as a liaison for clinical and scientific information exchange with regional oncologists, pathologists, oncology nurses, NPs, PAs and pharmacists
- Deliver high quality education and awareness presentations to ensure optimal patient care
- Obtain, assimilate, organize and report field insights in a concise, clear and compliant manner
- Provide timely, accurate, specific and balanced responses to professional requests for information in collaboration with medical communications
- Provide complete and timely documentation of interactions and contacts
- Administrative reports such as expense reports and status reports completed in a timely manner
- Provide reports, assessments and HCP insights in a clear, succinct and timely fashion
- Maintain and continually develop scientific knowledge of the relevant competitive landscape
- Attend and participate in all required compliance trainings
- Follow all laws, rules, regulations, guidance documents, codes, etc. associated or attributed the pharmaceutical industry
- Attend national, regional and local conferences and symposia in coordination with overarching company objectives
- Follow all company policies and procedures as well as those of applicable to collaborators and institutions
Your Profile:
The successful Medical Science Liaison is a proven self-starter with excellent problem-solving skills that meets the following requirement:
- M.D., Ph.D., Pharm.D. or NP/PA with appropriate clinical experience and scientific background
- 2+ years’ oncology clinical experience and 1+ years’ MSL experience in pharmaceutical industry
- Knowledge of pharmaceutical rules, regulatory law, guidelines and codes (e.g., PhRMA Code)
- Strong collaboration skills to coordinate efforts and accomplish goals as a team
- Demonstrate ability to develop trust and maintain integrity with internal and external partners, peers, and others
- Ensure the attainment of individual objectives and results as well as those for the assigned team
- Excellent interpersonal, verbal and written communication skills
- Ability to learn new scientific and technical information quickly
- Strong computer skills, proficiency in on-line data searches, MS Word, PowerPoint & Excel
- Ability to handle and prioritize multiple assignments and to meet deadlines in a fast-paced working environment
- Travel approximately 50% (car, plane, etc.)
Benefits
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, 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 and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
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 NL 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 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.
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 a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, 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 and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
Join our mission to close in on cancer.
The team:
As a member of our CMC (Regulatory Affairs team you will play an important role in managing, writing, preparation and review of RA-CMC regulatory filings for submissions of Merus’ product candidates in compliance with the applicable regulatory and quality requirements, as well as providing biopharmaceutical CMC-content related regulatory advice to the rest of the CMC team.
The role:
As Regulatory Affairs CMC Officer, your main tasks and responsibilities are the following:
- Preparation and co-review of CMC sections of regulatory filings;
- Managing Regulatory Affairs CMC-related projects of Merus’ product candidates both internally (with Merus colleagues) and externally (third parties);
- Ensuring that CMC regulatory filings are in compliance with internal procedures, regulatory guidelines and according to GMP, GLP and/or GDP, where applicable;
- Provide regulatory advice on CMC technical and quality matters to the rest of the CMC team, such as manufacturing process development, specifications, in process controls, and change control management;
· Managing the communication and follow-up with Competent Authorities on CMC regulatory related feedback received;
Your profile:
We are looking for a Regulatory Affairs CMC Manager, with the following knowledge and expertise:
- You hold a Master’s degree in a relevant biomedical field, and have at least 3 years of relevant working experience within the (bio)pharmaceutical industry, or other relevant regulatory experience;
- You have a good understanding of Regulatory Affairs (EU/US/ROW)
- You have good understanding of various quality systems such as GMP, GLP and GDP;
- You are a team player focused on results;
- You have an analytical mindset and attention for details;
- You are known for your organization skills and drive to continuously improve your work;
- You communicate well in English, both verbally and in writing.
Why Merus?
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.
The team
We are seeking a Senior Financial Controller for our Finance & Accounting team, based in our Utrecht office. Our team, consisting of four professionals, is dedicated to managing key accounting responsibilities for our two entities: the Dutch N.V. and the US Inc.
The Role
In this role, you will lead in preparing and executing detailed monthly accounting transactions, journal entries (including PO and non-PO), ensuring compliance with SOX and US GAAP. 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.
- Financial Reporting and Compliance: Ensure timely, accurate financial reporting for month-end, quarter-end, and year-end processes, in alignment with Nasdaq Global Market requirements for a large accelerated filer.
- Accounting and Transactions: Prepare and execute monthly accounting transactions, including journal entries for R&D, clinical accruals, drug substance/product accruals, and pre-paid expenses, ensuring detailed tracking and reconciliation.
- Collaboration and Oversight: Work closely with US accounting, internal project managers (Clinical and CMC), and other stakeholders like 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.
Requirements:
- Relevant education on master level in Accounting or (Business) Economics
- Strong knowledge of US GAAP and IFRS accounting principles related to a wide variety of topics;
- Experienced to work with SOX 404b compliance in a US listed public company
- You are proficient in all areas of financial accounting
- SAP experience is an advantage;
- Previous work experience in biotechnology or pharmaceutical industry is advantageous
- You’re fluent in Dutch and English
- You are able to work in an international environment across time zones
Why Merus?
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 on the lookout for an experienced Clinical Quality professional, GCP.
In this role you will support the Clinical Quality team that focuses on understanding the evolving regulatory landscape to build and enhance fit for purpose quality foundations that enable Good Clinical Practice (GCP) excellence. The Clinical Quality team strives to ensure that the clinical quality management system (QMS) is optimized to foster a culture where quality innovation matches the company’s cutting-edge and patient-centric science.
This role that will implement and optimize the risk-based quality strategy in coordination with the Clinical and the Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence.
Key Responsibilities
As Clinical Quality Senior Manager/Associate Director, GCP you will:
- Provide global GCP guidance for cross-functional development teams in order to build robust internal processes that ensure GCP/GVP compliant Sponsor oversight of the conduct of clinical trials. Partner with functional departments (e.g., Biometrics, Clinical Operations, Clinical Development, Safety) to enhance culture of quality.
- Participate in GCP inspections by regulatory authorities. Manage proactive GCP inspection readiness activities globally; Support questions from regulators, review boards, ethics committees, development partners, etc.
- Support issue management and corrective/preventive action management activities within company and with external service providers.
- Develop and implement risk-based audit plans which may include but are not limited to internal audits, clinical investigator audits, system audits, and vendor audits; Conduct and/or oversee audits in accordance with audits plans.
- Support efforts to identify and implement new technologies to optimize quality (e.g., electronic trial master file safety tools).
- Instill a culture for cross-functional review, ownership, management and filing of all documentation (internal and external) within the eTMF that is supportive of a clinical trial
Your Profile :
Our ideal candidate will have experience conducting and managing GCP/GVP audits and directly supporting Clinical Study Teams.
This is then backed up by following experience:
- 5 years of GCP quality experience.
- Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive).
- Understanding of GVP (e.g., European Union Directive 2010/84/EU and current modules) is a plus.
- Understanding of global clinical and safety regulations. As well as the clinical development lifecycle, ideally for large molecules.
- Experience managing GCP audit programs.
- Ability to effectively escalate quality concerns to Clinical Quality leadership
- Ability to manage multiple simultaneous projects.
- Commitment to diversity, equity, and inclusion.
Please note – we can support this role as a fully remote position – depending on location/state.
Our offer :
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, 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 and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
Merus is a clinical stage company striving to develop best-in-class therapeutics to treat and potentially cure cancer patients. Our most advanced development programs use the Biclonics® format to discover and develop therapeutic antibodies. Biclonics® are capable of simultaneously attacking tumors in multiple ways. For example by activating the immune system to kill tumor cells and directly inhibiting tumor cell growth and survival pathways!
The team:
In this role you have an opportunity to join us on the ground floor and build a high-functioning medical affairs organization. You will be working in an international cross-functional team, supporting the development of scientific communication platforms for novel bispecific antibody therapeutics. Joining Merus means joining our pursuit to develop advanced therapies that address unmet needs in cancer treatment. The successful candidate will report to the VP of Medical Affairs.
Your role:
We are seeking a medical affairs professional to build our scientific communications capabilities. The Head of Global Scientific Communications is a key leader on the Medical Affairs team and will oversee the development of our scientific narrative, communications strategies, medical publications, medical training, CME needs assessments, and medical information in support of Merus clinical programs.
In this role you will:
- Develop and implement medical affairs communication’s strategy for key oncology compounds
- Lead publications planning and execution
- Develop and execute global congress plan
- Develop innovative medical communications strategies, including digital medical communications
- Lead training for medical affairs and cross-functional colleagues
- Develop medical information capabilities and oversee the Zenocutuzumab call center
- Provide high quality medical and scientific communications content to internal and external stakeholders in various forums (e.g. MSL slide sets, advisory boards, trainings)
- Facilitate publication of data from Merus Clinical programs, RWE/HEOR analyses, Investigator-Sponsored Trials (IST), and other programs
- Manage vendors involved with key projects; manage project timelines and budgets
- Ensure compliant medical communications; following all Merus policies and ensuring that all communications are highly scientific and credible
- Oversee medical review, and MLR process for external materials and other internally planning documents
Your profile:
We are looking for professionals who:
- Hold an Advanced Degree (MD, PharmD, or PhD in relevant field) and have 10-15 years of professional experience in the pharmaceutical industry
- Have excellent interpersonal and teamwork skills
- Highly independent and proactive
- Experience with late-stage oncology development and product launch
- Excellent writing and oral communication skills (including presentations)
- Solid judgment and decision making
- Will comply to all required regulatory and GCP guidelines
- Excellent project and time management skills
- Ability to travel up to 30% travel, domestic and international
Our offer :
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, 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 and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
Join our mission to close in on cancer.
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.
Key Responsibilities
As Associate Director eTMF you we acting as TMF Subject Matter Expert for the clinical study team and supporting cross-functional departments to ensure high quality documentation.
- Oversee and manage the setup and ongoing review of studies within the Veeva system, acting as a Veeva Vault Expert. Be responsible for the set-up, management and archiving processes and execution of Vault including naming conventions and processes, migrations etc.
- Ensure the TMF is compliant and ready for inspections by auditors and regulatory authorities.
- Lead the development of procedural documents, TMF management plans, and related materials.
- Act as a point of contact for project teams, 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.
- Identify and implement process improvements in collaboration with stakeholders.
- Manage the budget proposals from third parties related to eTMF activities or systems.
- Lead and direct staff to ensure documentation activities comply with GCP, SOPs, and regulatory requirements.
- Oversee access management and ensure appropriate internal and external access to the eTMF system. Be a complete system owner and expert for Veeva Vault at Merus.
- Ensure compliance with global regulations and guidelines for TMF management.
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.
- 7-9 years of TMF management experience in global clinical trials.
- Experience with computerized clinical trial records management technologies, particularly Veeva systems.
- 3-5 years of personnel management experience.
- Strong organizational, writing, and communication skills.
- Advanced knowledge of ICH/GCP guidelines, FDA regulations, and international TMF regulatory requirements.
Our offer :
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part or Merus, 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 and a company bonus structure. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
This position can be based either in the US or Europe.
