Company Overview
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

We offer an exciting and dynamic work environment in the biotech industry. At Merus, you will collaborate with a diverse, international team passionate about advancing cancer treatments. Additionally, we provide:

  • A competitive compensation and benefits package.
  • Tailored training and development programs.
  • Career growth opportunities aligned with your ambitions.
  • The chance to contribute to groundbreaking research and innovative therapies.

Title: Associate Director – Director eTMF
Location: Cambridge, MA or Utrecht, NL
 
Company Overview
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 a competitive salary and flexible working hours. Our talented international team works in Cambridge, MA, USA and 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 on a full-time position. We care about team spirit and organize several company events each year. 

Location: Cambridge, MA; (Local Talent Preferred)
Work Schedule: Hybrid


Company Overview
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:


Merus is seeking a Finance Operations Manager who embodies a hands-on approach and thrives in an international setting, adept at navigating across time zones (Merus has offices in the Netherlands and US). This role is crucial to the success of Merus Finance Operations and is an exciting opportunity for a finance professional dedicated to innovation, collaboration and excellence. This position will be reporting to the Director of FP&A. 
 

In this role you will:  
  • Manage financial system SAP Business ByDesign, optimize the configuration and reporting needs, provide information to allow strategic and operational decision-making. This includes management of organizational structure, cost centers, projects, approval flow, Purchase Order review and approval etc.
  • Help business navigating through SAP i.e. give training to business on how to review and approve POs and supplier invoices, how to create a purchase order. Trouble shoot SAP issues for business or with the help of IT
  • Support quarterly accounting close process by directly interacting with business representatives
  • Identify opportunities for improvement, supports development and implementation of improved processes, tools and templates
  • Support the development of the annual budget and reforecast, long-range planning, ensure the ongoing tracking and management of these budgets/forecasts. 
  • Build relationships cross-functionally to foster collaboration both inside and outside of the Finance team
  • Play a key role in special projects, including cross Finance improvement initiatives or ERP system implementations driving financial efficiency and strategic growth

Your profile:


We are looking for a candidate with:
  • Bachelor’s degree in Finance or Accounting. (MBA is a plus)
  • 7+ years relevant experience in a financial planning and accounting role
  • Experience in the Pharmaceutical or Biotech industry (or similar) is required
  • Ability to understand and explain complex R&D financial underpinnings into clear and concise analysis and recommendations
  • Extensive experience in use of Excel and PowerPoint at an advanced level 
  • Strong collaboration skills to coordinate efforts and accomplish goals as a team 
  • Excellent interpersonal, verbal and written communication skills 
  • Ability to handle and (re)-prioritize multiple assignments and to meet deadlines in a fast-paced working environment 
  • Ability to work across departments and time zones.
 

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.


Company Overview

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics®, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients’ lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact. 
 

Your role:

Merus is seeking a Head of Clinical Pharmacology and Pharmacometrics to serves as the functional leader of the Translational Pharmacology, Clinical Pharmacology, and Pharmacometrics functions of the company. This position will be reporting to the VP of Clinical and Bioanalytical Sciences.

 
In this role you will:   

  • Serve as the functional leader of the Translational Pharmacology, Clinical Pharmacology, and Pharmacometrics functions of the company.
  • Be accountable for managing people, set the strategic direction of the group, and allocate resources.
  • Collaborate with other functions to integrate quantitative approaches throughout the product lifecycle, enhancing technical success and decision-making confidence. 
  • Partner with early research to provide foundational insights for optimization of key molecular attributes of mAbs and ADCs to inform prioritization from product concept to preclinical optimization.
  • Collaborate closely with clinical stage project teams to provide scientific insights that drive clinical development decisions and support regulatory submissions.

Your profile:

We are looking for a candidate with:
  • Ph.D. or equivalent degree with at least 15 years of industry experience.
  • Educational background in PKPD, pharmacometrics, chemical engineering, biomedical engineering, biostatistics, or mathematics.
  • Prior experience working with monoclonal and multispecific antibodies; experience with ADCs is preferred.
  • Demonstrated strong technical expertise in quantitative approaches to translational pharmacology, early research, and clinical development. 
  • Prior experience in using semi-/mechanistic modeling for target selection, target product profile optimization, and compound prioritization in early research.  
  • Track record in using modeling and simulation approaches to support regulatory discussions and Biologics License Application (BLA) submissions.
  • Experience in Oncology. 
  • Strong leadership skills with the ability to effectively influence cross-functional teams.
  • Strong work ethic, commitment to excellence, and openness to new ideas and feedback.

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.
Central US location preferred.

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 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. 

Job Title: Director – Senior Director, Benefits
Location: Cambridge, MA (This position requires candidates to be based in Massachusetts.)
Work Schedule: Hybrid

Company Overview

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. 

Merus is seeking an experienced Director/Senior Director of Global Benefits to join our Human Resources team. This leadership role will be pivotal in designing and continuously improving our benefits strategy and initiatives, positioning the company as an employer of choice within the industry. Reporting directly to the Chief People Officer, this position is based in our Cambridge, MA office. If you’re a seasoned benefits professional passionate about making a meaningful impact in the fight against cancer, we invite you to join our mission to close in on cancer.

In this role you will be responsible for:


Benefits Strategy Development & Implementation
  • Develop and implement region-specific benefits strategies that align with the organization’s global goals.
  • Design and manage the annual open enrollment process to ensure a seamless experience while maintaining competitive features and rates.
  • Analyze market trends and data to keep Merus competitive in the total rewards space and share insights with HR leadership to drive innovation.
Compliance & Governance
  • Ensure compliance with Leave of Absence, Workers Compensation, 401(k), and Non-Qualified Deferral Programs across all locations.
  • Oversee the administration of global compensation and benefits programs, ensuring adherence to local, regional, and country-specific regulations.
  • Maintain strong knowledge of benefits laws and regulations, including ERISA, ACA, FMLA, and international frameworks.
Stakeholder Partnership & Strategic Guidance
  • Partner with internal stakeholders to provide strategic guidance on total rewards programs and policies.
  • Collaborate with HR and Finance teams to ensure budget alignment and cost-effectiveness of total rewards programs.
  • Manage third-party and provider relationships to ensure effective service delivery and engagement.
Leadership & Team Management
  • Lead and mentor the global benefits team in both day-to-day operations and strategic initiatives.
  • Foster a collaborative environment to drive positive outcomes across the team and company.
Employee Wellness & Support
  • Design and implement comprehensive wellness programs that promote the physical, emotional, and mental well-being of employees.
  • Collaborate with HR to integrate wellness offerings into the benefits strategy, ensuring accessibility and inclusivity for all employees.
  • Provide support and resources to employees to help them navigate benefits offerings, balancing work and personal life, and maintaining overall health.
  • Drive initiatives that focus on long-term well-being, ensuring that Merus is fostering a healthy, resilient workforce.
Leave of Absence Management (U.S.)
  • Oversee the administration of Leave of Absence (LOA) programs in the U.S., ensuring compliance with federal, state, and local regulations.
  • Work with employees, managers, and HR to ensure seamless coordination of LOA requests and accommodations in accordance with applicable laws (e.g., FMLA, ADA).
  • Partner with internal teams to maintain accurate records and provide necessary support for employees on leave.

Required Skills, Knowledge, and Expertise


Educational & Professional Background
  • Bachelor’s degree in Human Resources, Business Administration, or a related field.
  • 10+ years of experience in total rewards or benefits, with at least 5 years in a leadership position.
  • Proven experience in global benefits administration and managing large-scale benefits programs.
Technical & Compliance Expertise
  • Deep expertise in vendor management, including leading RFPs, vendor negotiations, and oversight.
  • Strong understanding of benefits laws and regulations, including ERISA, ACA, FMLA, and international laws.
  • Ability to analyze and interpret complex data to make informed decisions.
Communication & Relationship Management
  • Excellent communication and interpersonal skills, with the ability to negotiate effectively and influence key stakeholders.
  • Strong relationship-building skills, both internally and externally, to drive positive business outcomes.

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.
Job Title: Director, HR Operations
Location: Cambridge, MA (This position requires candidates to be based in Massachusetts.)
Work Schedule: Hybrid

Company overview:
 
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. 

The Director of HR Operations will oversee HR operations in the Netherlands and Cambridge, MA ensuring alignment and effective coordination between global locations.

In this role, you will be responsible for:

  • HR Operations Leadership:
     
    • Oversee and manage all HR operations, including systems, processes, infrastructure, and data reporting across multiple global locations, ensuring operational excellence and efficiency. 
    • Collaborate with cross-functional teams to enhance HR systems, drive continuous improvement, and optimize workflows in line with business requirements.
    • Ensure alignment and effective collaboration with HR staff in the Netherlands through a dotted line reporting structure, providing guidance and support as needed.
  • Technology Strategy and Optimization:
     
    • Develop and execute a HR technology strategy that supports the company’s business objectives, ensuring technology enhances HR operations and aligns with evolving business needs.
    • Lead the evaluation, implementation, and continuous improvement of HR systems, ensuring the systems enable seamless, compliant, and efficient people operations.
  • Employee Onboarding & Offboarding:
     
    • Manage end-to-end employee lifecycle processes including onboarding new hires and offboarding exiting employees, ensuring a smooth and engaging experience while maintaining compliance with relevant regulations.
  • Data Management & Compliance:
     
    • Maintain accurate and up-to-date employee data, ensuring it meets legal requirements and supports business decision-making. This includes data around employee contracts, compensation, personal data, performance, and promotion records.
  • HR Metrics & Analytics:
     
    • Utilize HR data to analyze key metrics and identify trends that provide insights into workforce performance, engagement, and organizational health.
    • Develop actionable insights from HR data to drive continuous improvement, enhance employee experience, and inform key business decisions.
  • Employee Engagement & Retention:
     
    • Drive initiatives that increase employee engagement, retention, and alignment with company culture, contributing to a positive and productive workplace.
  • Collaborate with Leadership:
     
    • Support the Chief People Officer (CPO) with board-level materials and strategic presentations as needed.

Skills, Knowledge and Expertise

We are looking for a candidate who possesses the following:
  • Educational Background:
     
    • Bachelor’s degree in Human Resources, Business Administration, Finance, or a related field.
  • Professional Experience:
     
    • A minimum of 7 years of experience in HR operations, ideally within a global biotech or pharmaceutical company.
    • Proven success in leading HR operational initiatives and implementing solutions that enhance efficiency and performance.
  • HR Systems Expertise:
     
    • In-depth knowledge of HR technology platforms, data management, reporting tools, and industry best practices.
    • Experience in optimizing HR systems and driving innovation to improve processes and outcomes.
  • Analytical Skills:
     
    • Strong data analysis skills, with the ability to interpret HR metrics to drive decisions and create actionable insights.
    • Experience in using HR data to inform strategic decisions and improve overall HR operations.
  • Strategic Mindset & Communication Skills:
     
    • A strategic thinker who can develop HR operations strategies that align with broader business goals and organizational objectives.
    • Excellent communication and interpersonal skills, with the ability to collaborate effectively with both technical and non-technical teams across the organization.

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.

Company Overview
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics®, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients’ lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact. 

Your role:


 Merus is seeking a Sr/Exec Director, Pharmacovigilance (PV) Operations who will be accountable for overall PV operations for Merus, which includes all aspects of adverse event collection, processing and reporting from all sources, safety systems, alliance and vendor management, development and training activities, for the entire portfolio in clinical development and post approval.  The Sr/Exec Director leads the PV operations team and plays a critical leadership role in internal and external collaboration to ensure PV operational excellence and regulatory compliance.  
The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge, MA office location and will be expected to travel to the office as needed for meetings and other business needs.

In this role you will:
  • Lead, manage, and develop PV operations team
  • Work with the drug safety leadership team, to develop the strategy and implementation of PV system, processes and vendor deployment 
  • Manage the global PV processes to ensure compliance with all applicable laws and regulations
  • Responsible for all PV operational aspects for entire portfolio in clinical development and post approval 
  • Ensure that all safety reports received from any source are processed and reported according to ICH guidelines, regulatory requirements, and company SOPs and procedures
  • Mange PV team that oversees execution of ICSR collection, processing, reconciliation and reporting, including associated quality and training activities to ensure regulatory timelines and global standards are met
  • Facilitate and ensure communication with internal functions and external vendors and license partners involved with receiving, investigating, or reporting AEs
  • Oversee PV vendors performing case management and study support activities; oversees the development of maintaining of study-specific safety management plans
  • Lead the development of PV agreement with license partners and/or other parties as required
  • Operationally support signal detection, aggregate report preparation and safety labeling updates 
  • Support the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, IND/NDA/BLA/MAA and other regulatory submissions
  • Oversee PV audits, inspections, CAPA activities as required
  • Prepare and maintain drug safety departmental policies that address the processing, analysis and reporting of safety information to ensure proactive surveillance of compounds across life cycle.
  • Ensure awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOP
  • Oversee PV operational personnel that contributes to DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety label
  • Provide PV guidance and support for interdepartmental and/or corporate initiatives
  • Participate in the development and management of departmental budget planning, negotiation, and implementation including long-range department operational planning.

Your profile:

We are looking for a candidate with:
  • Bachelor’s Degree including a Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences and extensive drug safety experience in oncology highly desirable
  • Minimum 15 years of PV operations experience within the biotechnology or pharmaceutical industry is required, including 8 years in management position with direct reports
  • Previous demonstrated success in leading PV operations function in the industry
  • High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
  • Expert knowledge of global PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
  • Experience and extensive working knowledge of MedDRA and proprietary safety databases, PV processes for individual case medical review, signal detection and evaluation, aggregate data assembly, review and report, as well as clinical study safety management
  • Experience managing business process outsourcing vendors and relationships
  • Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
  • Experience with audits and inspection
  • Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
  • Proficient with Microsoft Office 
  • Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail
  • Experience with signal detection and risk management tools is a plus

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.
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.

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.

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