The Quality Systems department is responsible for the development, maintenance, and evolution of the Quality Management System of Merus to ensure compliance with international regulations and support the achievement of quality objectives. As Quality Systems Associate you act as Business Administrator of Merus eQuality Management System.
The Role:
In this position, you will be responsible for overseeing, supporting, and coordinating various aspects of the Quality Management System. Your key responsibilities will include:
- Act as Business Administrator and coordinate all aspects of the full operation of Merus eQMS including:
- Document Management
- Learning Management System (including study specific training)
- QMS (Change Control, Deviation handling, CAPA, Complaints, Supplier Management, Audit & Inspection)
- Manage GxP documents and ensure training is assigned appropriately
- Foster a quality mindset around Good Documentation Practices
- Collaborate with all GxP departments to provide customer service, analyze system incidents, and introduce system optimization
- Contribute to continuous development of Merus’ Quality Management System to address changing needs of Merus
- Compile, monitor and trend Merus quality indicators for weekly, monthly, and quarterly Quality Reviews
- Participate in and prepare for (internal) audits and inspections as SME.
In addition, you will support in several other areas, such as inspection activities, contractor qualification audits and assessing changes/new developments in GXP regulatory in order to roll them out internally.
Your Profile:
Your Profile
We are looking for a highly organized and detail-oriented individual with experience with Document Management Systems. The ideal candidate will have a background in document control and quality management processes. It is a big plus if you have had any experience participating in audits and inspections. Effective communication skills, ability to collaborate and a proactive approach to continuous improvement are essential.
Requirements:
- Degree in Biosciences or related field
- Minimum of 2-3 years relevant GMP work experience within biotechnology/ pharmaceutical /medical device industry, in a manufacturing or quality environment.
- Experience with MS Office (Word, Excel in particular)
- Proficient in an eDMS/LMS system, experience as business administrator is a plus.
- Knowledge of GMP; working knowledge of GCP, GDP
- Fluency in English (written and verbal)
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 in the Netherlands). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.
Merus is looking for a Senior QA Associate -Quality Systems/ CSV.
The Quality Systems department at Merus ensures compliance and quality across all GxP processes and systems. They maintain and improve the Quality Management System, oversee computerized system validation, and ensure compliance with regulations and data integrity. The team collaborates with various functional areas to support regulatory compliance and drive process improvements.
Your Role:
In this role, you are responsible for the QA oversight on Computerized System Validation (CSV) activities for GxP systems at Merus, ensuring compliance with regulations and data integrity. You will be a strong contributor to the maintenance and development of Merus’ Quality Management System, ensuring the successful application of Quality and Regulatory Standards.
Your key responsibilities will include:
- Quality oversight on CSV and Computerized System Lifecycle activities to ensure GxP computerized systems are and maintain properly validated
- Quality assessment and approval of deviations, change controls, CAPA
- Contribute to continuous improvements and the Regulatory Intelligence program to maintain and develop the Quality Management System and improve business processes
- Identify, assess, and mitigate risks on data integrity (DI) in projects / data handling processes
- Develop training material and train end users on QMS processes, CSV, and Data Integrity.
Areas of Support:
- Collaborate and advise cross-functionally to ensure compliance and initiate process improvements
- Support functional areas (Clinical, CMC, IT, Research) and develop necessary procedures and validation documents
- Participate in the Regulatory Intelligence Program and assist in the Business Administration of Merus eQMS
- Audit external parties and internal Quality Systems, focusing on – but not limited to- Computerized System Lifecycle Management
- Supplier Qualification including review of Quality Agreements
- Contribute to preparation and management of inspections as CSV/DI Expert and Quality Systems SME
Your Profile:
We are seeking a detail-oriented individual who excels in driving change and promoting a quality culture. The ideal candidate will have strong analytical and critical thinking skills, capable of managing multiple projects independently. Excellent communication skills and the ability to collaborate effectively at all levels are essential. Persuasiveness and a proactive approach to continuous improvement are key attributes.
Requirements
- At least 6 years of QA-related GXP working experience, within (bio)pharma
- Master in life sciences
- Knowledge of GMP and/or GCP
- Solid experience in Computerized System Validation and Data Integrity principles in GMP and GCP
- Experience with Project Management
- Experience in Lean Six Sigma methodology
- Fluent in English
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 in the Netherlands). 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.
The Senior Director, CMC Regulatory Affairs is responsible for managing all Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities for Merus’ product candidates, from the transition from Research to Development through to product licensure.
The role will be responsible for the oversight and leading the development and implementation of CMC regulatory strategies, ensuring timely and compliant regulatory submissions, and managing the coordination of internal and external CMC regulatory activities, including those related to co-development partnerships.
Your Role:
This role requires significant expertise in regulatory affairs for biologics and/or bio-pharmaceuticals, with a deep understanding of global regulatory frameworks (EU/US), GMP, GLP, GCP, GDP, and GRP. The Senior Director will work cross-functionally to ensure seamless integration of CMC regulatory strategies into development programs, enabling the timely progression of clinical trials and product development. This position is based in Utrecht, the Netherlands.
Areas of Full Responsibility:
- Preparation, Review, and Approval of CMC Regulatory Filings: Lead the preparation and regulatory submission of CMC sections for regulatory filings (e.g., IMPD/IND/MAA/BLA). Ensure all submissions are accurate, compliant, and submitted in a timely manner.
- Oversee CMC Regulatory Affairs Strategy: Jointly develop and implement CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
- Management and Coordination of CMC Regulatory Activities: Oversee and coordinate all internal and external CMC regulatory activities related to Merus’ product candidates, including activities with external partners and contractors, and those in co-development or partnership.
- Contractor Selection and Performance Monitoring: Lead the selection, evaluation, and monitoring of contractors for CMC regulatory affairs activities. Ensure contractors meet quality and performance standards, managing relationships to ensure timelines and deliverables are met.
Areas of Support:
- Defining CMC Regulatory Affairs Strategy: Jointly develop the CMC regulatory strategies for Merus’ product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
- Regulatory Affairs Department Creation: Work in cooperation with Clinical Regulatory Affairs to establish and support a regulatory affairs department.
- Approval of CMC Regulatory Affairs Contractors: Support the approval process for contractors and vendors involved in CMC regulatory activities.
Key Activities:
- Status and Planning Reporting: Regularly report on the status and planning of CMC regulatory affairs dossiers and submissions to internal stakeholders, ensuring proactive communication of timelines, milestones, and potential risks.
- Manage and coach: Lead and mentor the CMC- RA team, which consistst of 3 team members, working collaboratively with to achieve goals.
- Conflict Management and Escalation: Ensure any conflicts between Merus and external contractors/vendors related to CMC regulatory affairs are identified, addressed, and escalated as necessary to ensure timely resolution and project success.
Your Profile:
- MSc or PhD in Life Sciences, Bio-engineering, or a related field.
- At least 12 years of relevant working experience within the (bio)pharmaceutical industry or in other relevant regulatory functions, with strong expertise in CMC regulatory affairs.
- Proven experience in CMC regulatory submissions (IND/IMP/MAA/BLA) for both biologic products and small molecules.
- In-depth knowledge of Regulatory Affairs in the EU and US markets, with a strong understanding of relevant regulatory frameworks.
- Extensive knowledge of GMP, GLP, GCP, GDP, and GRP guidelines and regulations.
Skills and Competencies:
- Strong leadership and project management skills with the ability to coordinate and manage multiple cross-functional teams, including external contractors and partners.
- Ability to think strategically and contribute to the development of CMC regulatory strategies.
- Excellent communication and interpersonal skills, with the ability to collaborate across functions and manage regulatory relationships with external stakeholders.
- Strong problem-solving and decision-making skills, with the ability to handle complex regulatory issues effectively.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Why Merus?
This is a critical role in a fast-growing company that offers the opportunity to influence the regulatory strategy for innovative biologics. As a Senior Director in CMC Regulatory Affairs at Merus, you will play a key role in advancing groundbreaking therapies to treat cancer and other serious diseases. You’ll have the chance to make a significant impact on both the development of new treatments and the long-term success of the organization.
The position is based in Utrecht, the Netherlands, offering a dynamic and supportive work environment with the opportunity to collaborate on a global scale.
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/Director, Pharmacovigilance (PV) Scientist who will be accountable for overall PV science support for pharmacovigilance department at Merus, which includes working in collaboration with the Global Safety Physician(s) to lead signal detection activities conducted in the safety governance model within the company. This includes review of adverse event and laboratory data as applicable, Serious Adverse Events reported in clinical trials, and literature relevant to the products assigned. The ideal candidate will play a critical role in further developing and enhancing PV processes and procedures relative to the PV scientist role.
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:
- Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products at Merus.
- Works in collaboration with the Global Safety Physician to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
- Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
- Leads the collaboration with Safety and Clinical representatives, and authors the Reference Safety Information (RSI) for assigned products based on the developed benefit-risk profile.
- Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
- Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the Global Safety Physician and other functional experts.
- Contributes to pharmacovigilance and risk management planning for Merus products, including preparation of the safety aspects of Risk Management Plans with the applicable License Partners as appropriate and REMS if applicable.
- Supports multidisciplinary Safety Management Team and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the Global Safety Physician.
- Additional projects as assigned
- Participates in PV audits, inspections, CAPA activities as required
- Contributes to drug safety departmental policies and procedures that address signal detection and management, safety governance, and periodic reporting as applicable.
Your profile:
We are looking for a candidate with:
- Bachelor’s in sciences/pharmacy/nursing degree or related field Bachelor’s degree in health-care related discipline or equivalent, RN, R.Ph., or Pharm D. degree is highly preferred
- 8+ years of proven pharmacovigilance experience preferably in oncology
- Experience working in safety &/or scientific activities in the setting of Product Safety Team/Safety Management Team model
- Experience with Early and Late Phase development clinical trials and safety surveillance and signal detection processes
- High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
- General knowledge and understanding of US and EU 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 reporting, as well as clinical study safety management
- 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
- Previous MAA/BLA experience including contributing to the preparation and authoring of the safety related aspects of the Common Technical Document
- Experience with audits and inspection
- Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
- Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail
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.
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.
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 Senior Medical Director to serve as the global safety officer for the pharmacovigilance and risk management of assigned investigational and/or marketed oncology products at Merus. This person will be responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. The global safety officer plays a critical leadership role in the program team through the product life-cycle, working in close collaboration with Pre-clinical Safety, Clinical Development, Biostats, Medical Affairs, Regulatory Affairs and other functions at Merus. They will work effectively with key stakeholders and business partners on strategy and tactical safety issues, and keep senior management informed of evolving safety profiles, plans, and execution issues. May represent Merus at internal and external meetings, including interactions with global regulatory authorities.
The successful candidate will have demonstrated accountability and a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders either verbally or in writing with impact.
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:
- Chair Safety Management Team for assigned products at Merus
- Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with Pharmacovigilance staff, to include the following:
- Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
- Design, implement and ensure routine signaling activities, assessments and investigations are effectively completed and documented in a timely manner
- Respond to product safety queries from all sources including ethics committees and regulatory authorities
- Lead product benefit-risk assessment and presentation to the Safety Management Team and Executive Safety Committee and any needed actions, for example, IB update, update to patient safety information, or modifications to protocols
- Lead Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams with critical roles which include:
- Strategic advisement on clinical development plans, design of clinical protocols
- Responsible for safety content of IB and ICFs and support of DSMBs
- Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
- Content of Risk Management Plan/ REMS (as required)
- Advisement on the design of post-approval safety studies
- It is expected that the global safety officer will establish a high level of trust and collaboration with cross-functional counterparts in carrying out these activities
- Ensure development and implementation of other department goals, policies and strategies in collaboration with the VP Pharmacovigilance, consistent with regulatory requirements and industry best practices
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
- Other job duties that may be assigned according to business needs
Your profile:
We are looking for a candidate with:
- MD, or MD PhD, or MD MPH required
- Minimum 8-10 years of PV MD experience within the biotechnology or pharmaceutical industry is required
- Strong background and previous experience in Product Safety/Safety Management Team (or similar model) lead (PST/SMT Lead) with strategy oversight is preferred
- Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
- 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 individual case medical review, signal detection and evaluation, and clinical study safety management
- 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
- Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail
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.
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 Director, Pharmacovigilance (PV) Operations who will implement and coordinate PV department procedures at Merus, provide strategic direction and oversight of day-to-day operations, and ensure compliance with adverse event collection and reporting requirements. This role will also be responsible for the operational management and oversight of case processing activities performed externally by vendors, working across internal stakeholders to contribute PV support to clinical trials, contributing to case management database strategy, and quality and compliance including inspection readiness and training.
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:
- Provide effective vendor management strategies for PV for both pre and post market products
- Manage all PV vendor related activities including scope of work, safety management plans, contracts, training, and oversight of outsourced case processing work
- Support and oversee all vendor activity related to individual case safety reports (ICSR), aggregate reports (DSUR, PSUR, and PADERs), compliance metrics, and expedited reporting
- Serve as lead for Quality and Compliance within PV and ensure PV department inspection readiness
- Provide PV Operational support to clinical trial study teams including the development and review of core safety documents such as ICFs, IBs, protocols, and supporting other study activities such as SAE reconciliations and authoring safety sections of clinical study reports
- Work closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, and Medical Affairs, to maintain robust pharmacovigilance practices in line with global regulatory standards
- Contribute to PV agreements with license partners and/or other parties as required, and support such alliances from operational perspective
- 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
- Serve as PV lead for escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed
- Manage the creation and the periodic review of PV procedural documents such as SOPs to support pre and post market products
- Ensure awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOP
- Provide PV guidance and support for interdepartmental and/or corporate initiatives
- Participates in the development and management of departmental budget planning
Your profile:
We are looking for a candidate with:
- Bachelor’s degree in science area, pharmacy, nursing, or a related field
- Minimum of 8 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical/biotech industry
- Minimum of 4 years managing PV vendors
- In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, GVP)
- Proficiency with safety databases (e.g., Argus, ArisG) and coding dictionaries (MedDRA, WHO-DD)
- Knowledge of pre and post marketing PV regulations including GVP regulations
- Demonstrated track record of experience and successfully managing business process outsourcing vendors and relationships
- Highly innovative and self-motivated, with excellent time management and organizational skills
- Ability to proactively assess department risk related to process/procedure and provide remediation
- Experience with quality and compliance function within PV, including inspection readiness strategy development and implementation, and previous inspection experience required
- Experience with reviewing of safety documents such as DSURs, IB, PBRERs/PADERs
- Ability to work collaboratively with cross-functional teams
- Experience with signal detection and risk management tools is a plus
- Proficient with Microsoft Office
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.