Data Management (Senior Director – Executive Director)
 
This role is US based.
 
The team
You will be working in our Clinical Development department, providing strategic direction and team development and report to the Vice President Biometrics.

Key Responsibilities

The role
As the Executive Director, Data Management, you will provide departmental leadership and organizational strategy to the Data Management function focusing on strategic direction and team development. Furthermore, your day-to-day tasks will include:
•      Support development of the resourcing model for DM and development informatics.
•      Coach and further develop internal talents.
•      Ensure the balance of internal and external (vendor) expertise to secure availability of the right talent.
•      Establish and monitor effective and efficient resourcing.
•      Establish a strategy for capability and skill development to meet current and future requirements.
•      Establish outsourcing strategies and execution of such strategies in support of business and financial objectives with accountability for functional budget.
•      Maintain an environment to foster creativity and transparency, and a framework for continuous improvement.
•      Drive standardization and innovation to ensure future fitness of the organization.

Skills, Knowledge and Expertise

Your profile
Required experience and skills:
–          15+ years of relevant work experience in biopharmaceutical industry, with
–          Demonstrated leadership experience, specifically managing teams in areas of data management, data governance, development informatics, data quality.
–          Domain knowledge and leadership experience in data management, development informatics, clinical programming, data platforms.
–          Strong leadership and team building skills, must be able to collaborate effectively with a group of high performing individuals.
–          Strong communication skills with ability to align the company on complex technical decisions.
–          Active coach and mentor whose goals are to grow and maximize the team’s potential.

Benefits

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.   
Statistical Programming (Senior Director – Executive Director)
 
This role is US based.
 
The team
You will be working in our Clinical Development department, providing strategic direction, team development and technical leadership. You will report to the Vice President Biometrics.

Key Responsibilities

The role
As the Executive Director, Statistical Programming, you will provide leadership and line management to Statistical Programming function, establish standards for statistical reporting, support resourcing, develop and maintain processes. Furthermore, your day-to-day tasks will include:
•      Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and Merus’ values.
•      Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables.
•      Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets.
•      Establish and monitor effective and efficient resource sharing.
•      Maintain strategy for capability and skill development to meet current and future requirements.
•      Establish outsourcing strategies and execution of such strategies in support of business and financial objectives with accountability for functional budget.
•      Maintain an environment to foster creativity and transparency, and a framework for continuous improvement.
•      Drive standardization and innovation to ensure future fitness of the organization.

Skills, Knowledge and Expertise

Your profile
Required experience and skills:
–          Advanced degree preferred. 15+ years of relevant work experience in biopharmaceutical industry and at least 5 years of experience managing a team.
–          Track record of leading and overseeing global regulatory submissions in oncology.
–          Superior knowledge and prior experience in setting strategy around the development of efficient analysis and reporting deliverables.
–          Solid experience with reporting proceses, regulatory requirements, and software development life cycle.
–          Strong leadership, interpersonal, and organizational skills, and ability to work within cross-functional teams.
–          Strong project management skills.
–          Strong communication skills with ability to align the company on complex technical decisions.
–          Active coach and mentor whose goals are to grow and maximize the team’s potential.

Benefits

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 seeking a Director QA / Qualified Person (QP) to oversee the quality assurance aspects of our biological products throughout their lifecycle.

Due to the holiday season, we will not be reviewing or responding to individual applications until January 6, 2025. We appreciate your understanding and patience during this time.

This role is crucial for ensuring compliance with GxP standards and regulatory requirements, thereby safeguarding the integrity and safety of our products. Positioned in a unique role as per EU legislation, you will be the end-responsible for the release of assigned Merus’ products, making pivotal decisions that impact GxP operations.

Your Role:

As the Director QA / QP, you will provide strategic oversight and hands-on management across various phases of product development  for selected products/clinical studies. Reporting to the Head of QA, and supported by a couple of direct reports, you will:
  • Oversee and manage all project-related QA activities for assigned projects, ensuring timely QA support to product development activities and compliance with internal quality management system (QMS) and GxP requirements.
  • Hold the end responsibility for the decision and approval on final product disposition as the Qualified Person, certifying batch release or rejection based on compliance with GMP.
  • Evaluate quality-related events such as deviations, complaints, and recalls to determine product impact, making decisions on material acceptance or rejection.
  • Maintain and update the Quality Systems in line with regulatory developments and company evolution.
  • Lead GMP/GDP audits as the Lead Auditor, ensuring contractor operations comply with GxP, regulatory filings, and quality agreements.
  • Act as a quality advisor, reviewing and approving project documentation, regulatory filings, and quality agreements.
 

Your Profile:

We are looking for a highly experienced and knowledgeable QA professional who can navigate complex regulatory environments with a strategic and proactive approach. Your ability to make critical decisions and lead quality initiatives will be key to your success in this role.

Requirements: 

  • A Master’s Degree in Pharmacy or Biosciences, PhD preferred, and eligibility for registration as a QP as defined in EU Directive 2001/83/EC.
  • At least 10 years of relevant GMP work experience in the biotechnology or pharmaceutical industry, including substantial QA experience and at least 5 years in quality leadership.
  • At least 5 years of experience as a QP, ideally for clinical products.
  • Expert knowledge of GMP/GDP, with a good understanding of GLP, GCP, and up-to-date knowledge of pharmaceutical laws and legislation.
  • Fluency in English, with excellent communication skills to interact effectively across all levels of the organization and with external stakeholders.
  • Demonstrated leadership in managing quality assurance teams and projects, with a track record of maintaining high standards of compliance and integrity.
This role offers the opportunity to take on significant responsibilities within a dynamic environment at Merus, driving the quality assurance strategy that supports the delivery of innovative treatments. If you are committed to excellence in quality and regulatory compliance and seek a challenging role where you can make a substantial impact, we encourage you to apply.

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! Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus. 
Due to the holiday season, we will not be reviewing or responding to individual applications until January 6, 2025. We appreciate your understanding and patience during this time.

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;
  • 6-8 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. 
Due to the holiday season, we will not be reviewing or responding to individual applications until January 6, 2025. We appreciate your understanding and patience during this time.

As a Financial Accountant reporting to the Director of Finance & Accounting, you will ensure accurate, timely, and complete execution of assigned tasks in compliance with internal guidelines, SOX, and US GAAP standards. You will work on both N.V. and Inc. books, collaborating seamlessly within the team to meet timelines and requirements.

Your Role

 This role demands deep accounting expertise, an ability to maintain oversight of the broader financial landscape, and a proactive approach toward continuous improvement and optimization. You will be responsible for :
  • Month-End, Quarter-End, and Year-End Close: Contribute to a seamless close process for assigned areas, ensuring timely and accurate financial reporting.
  • Accounting Transactions: Execute daily, weekly, and monthly journal entries, maintaining financial accuracy and compliance.
  • Cash and Investments Reconciliations: Perform monthly reconciliations to ensure alignment with financial records and comply with guidelines.
  • Fixed Assets Management: Manage tangible and intangible assets, including additions, disposals, impairments, and depreciations.
  • Manual Journal Entries: Execute manual journal entries including back up and evidence and conduct necessary adjustments through manual journal entries.
  • Accruals and Prepaid Expenses: Responsible for SG&A accruals, pre-paid expenses, and IP/legal accruals.
  • Payment Controls: Oversee weekly payment batch controls to ensure accuracy and compliance.
  • VAT Returns: Prepare and submit VAT returns accurately and timely.
  • Cross-functional Support: Provide hands-on support to other accounting areas as needed.
  • Reconciliations: Prepare reconciliations for month-end closing within your area of responsibility.
  • Process Improvement: Actively initiate and contribute to improvements in financial processes.
  • SOX Controls: Execute and document SOX controls in designated areas, ensuring regulatory compliance and contribute to process narratives.
  • Internal and External Audits: Serve as a liaison for internal and external auditors, supporting quarterly and annual audit processes.
  • Internal Controls: Perform routine internal controls and contribute to SOX controls on a regular basis to ensure adherence to financial policies and standards.

Your Profile

We are looking for someone with excellent interpersonal skills, with the ability to build strong working relationships. You will have an innate sense of urgency and strong attention to detail, with a high level of accuracy. You handle your cases and workload proactively, with a hands-on approach and a focus on continuous improvement. Ideal candidates will also meet the following requirements:

  •  Bachelor’s degree in Accounting, Finance, or a related field.
  • 5-7+ years of GL accounting experience or in similar function
  • Proficient in accounting principles, with proven technical and hands-on experience in financial accounting.
  • SAP experience is (highly) advantageous; advanced proficiency in Excel is essential.
  • Language Proficiency: Fluent in Dutch and English, with the capability to work effectively across international time zones

This full-time role offers an opportunity to bring your accounting expertise to an international team, drive impactful improvements, and contribute to high standards of financial integrity and operational efficiency.

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.   

Equal Employment Opportunities

Merus is an equal employment opportunity employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, age, ancestry, disability or perceived disability, qualified handicap, gender identity, military status, veteran status, certain criminal records, genetic information or testing, HIV testing, or any other characteristic protected by applicable federal, state or local laws (each, a "Protected Characteristic"). We are dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

Fraudulent Recruiting Activities

Please be cautious of scam recruitment offers claiming to be from Merus. Such scams may come from various sources, including unsolicited email using Gmail of other non-Merus email addresses or via text. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. If you have been the victim of such a scam, please report it to Internet Crime Complaint Center(IC3) | Home Page if you are living in the US or report it to the police Aangifte of melding doen | politie.nl if you live in the Netherlands.