The team:
The clinical operations team consists of more than 20 highly collaborative and engaging professionals. You will be working in an international cross-functional team, supporting the development of revolutionary bispecific antibody therapeutics. Joining Merus means joining our pursuit to develop advanced therapies that address unmet needs in cancer treatment. The successful candidate will be based in Cambridge, MA, and report to the VP of Clinical Operations

Your Role:

The Associate Director Clinical Operations will direct the Clinical Trial Lead, and any Senior and Expert Clinical Managers to properly conduct the clinical research projects on time, within scope and delivery according to plan within the requested quality specifications. 

  • Responsible for managing all key elements of clinical operations for the global Phase 3 clinical trial in coordination with the Executive Director of Clinical Operations;
  • Responsible for the execution of an inspection readiness program for GCP inspection of the Phase 3 program at Merus from the initial start-up phase of the study through to submission of the program;
  • Responsible to oversee continuous cross-functional data review (creation of outputs & coordination of review), facilitate the necessary cleaning processes internally and with the global CRO 
  • Responsible for creating and implementing global GCP policies and procedures within the program, including vendor oversight plans to ensure adequate documentation of clinical trial set-up and execution;
  • Responsible to keep the stakeholders informed on status and progress;
  • Responsible for facilitating eligibility and independent response data review; ensure oversight of the processes, provision of the necessary documentation to ensure patient eligibility and ensure integrity of the data for the primary and secondary endpoint reviews 
  • Maintains good working relationships with vendors, investigators, relevant site staff, consultants

Your profile:

The successful Associate Director Clinical Operations works well in cross-functional teams and is an excellent communicator. This will be backed up by the following:

·         A University Degree in biomedical sciences or related field
·         At least 10 years clinical research experience including relevant phase 3, oncology, inspection preparation and global trial experience
·         An ability to work both independently and in a collaborative team environment
·         Experience working with budgets and forecasts for clinical trials
·         Excellent knowledge of MS office word/excel/ projects.

Benefits

This is a unique opportunity to join a dynamic and innovative team with high visibility. We offer a competitive salary and benefits package, along with a collaborative and stimulating work environment. If you are skilled and motivated, we would love to hear from you!
For the Human resources team at Merus we are looking for a Recruiter/ HR Operations Assistant, located in Cambridge, MA (USA) 
 
The team:
The Human Resources Team within Merus is responsible for attracting, developing and retaining top talent to help us fulfill our mission. Every day we strive to be an employer of choice and to create and atmosphere in which professionals excel.  Our small, dedicated team is in charge of all the HR processes and policies for our fast-growing international organization and is always available to address HR needs from managers or individual employees. We like to get the job done, stay pragmatic and have fun while making sure our specialists can focus on what they do best.

Your Role:

The Recruiter / HR Operations Assistant will play a key role in the HR team, you will be coordinating the recruitment activities and act as first point of contact for our new hires in the US. Furthermore, you will be delivering operational and administrative support on all HR matters including working directly with employees and new hires to answer their HR-related questions. 

These will be your day-to-day tasks:

  • Coordinate the recruitment process in the US; in close cooperation with our recruiter in NL, hiring managers and external agencies you are able to find and attract talent for our company;
  • Coordinate onboarding activities, including benefits orientation and training, in such a way that our new employees feel welcome and have all the information and IT equipment they need;
  • Facilitate all training activities by booking locations, send out invites and report feedback afterwards;
  • Assist with employee benefits programs, including enrollment, changes, and terminations;
  • Administrative support on all HR policies and procedures;
  • Maintain records of personnel-related data in both paper and the database and ensure all employment and training requirements are met;
  • Facilitate annual performance evaluations and compensation reviews for all employees;
  • Support the HR team with data analysis, research and reporting;
  • Ensure compliance with federal, state, and local employment laws and regulations are posted;
  • Assisting the manager and IT with offboarding activities.

Your Profile:

We are looking for a candidate with a background in the industry- with a mix of HR and recruitment experience, who can operate individually on our Cambridge location. 

The successful Recruiter /HR Operations Assistant will meet the following requirements:

  • Relevant experience in a supporting role within an HR and/or Operations team;
  • Profound experience with talent acquisition in an international organization, preferable in Biotechnology / Life Sciences;
  • You are organized, precise and have oversight experience;
  • You are on top of your work and service oriented;
  • You have experience in working with various (HR) systems (preferable SuccessFactors);
  • Excellent skills in Excel and PowerPoint.

Why Merus?

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus. 
Merus is seeking an experienced Senior Statistical Programmer to join our Biometrics team. You will be responsible for performing daily statistical programming tasks for all phases of Merus clinical trials including oversight of CRO statistical programming activities and support other functional areas such as data management and biostatistics. You will be reporting to the Vice President of Biometrics. 

Your Role

In this role, you will leverage your expertise in statistical programming to support multiple facets of clinical development. You’ll ensure that data handling and analyses are conducted according to the highest standards, providing critical insights for strategic decision-making. 


As a Senior Statistical Programmer, you will: 

  • Develop and execute statistical programming tasks for internal and external purposes, including health authority interactions, such as briefing books and conference presentations. 
  • Provide oversight of CRO statistical programming activities, ensuring quality and adherence to timelines. 
  • Produce statistical outputs according to specifications for internal data reviews and clinical trial updates. 
  • Review SDTM and ADaM specifications and datasets, contributing to the development of internal specifications for analysis datasets. 
  • Program and update dashboards for ongoing studies, ensuring accurate and timely information flow. 
  • Engage in project management of programming activities across multiple trials, enhancing the efficiency and output of our biometrics functions. 

Your Profile

We are seeking a dynamic and skilled professional who can manage complex datasets and contribute effectively across different phases of clinical development. Your analytical skills and proficiency in statistical software will play a crucial role in the advancement of our clinical research.

We are looking for a candidate with: 

  • A University Degree in Science or a related field; an advanced degree is preferred. 
  • At least 5 years of experience in the pharmaceutical industry with a solid foundation in statistical programming. 
  • Proficiency in SAS, R, and familiarity with CDISC standards, including specific knowledge of RECIST 1.1. 
  • Demonstrated ability to work collaboratively across various teams, including Biostatistics, Clinical Data Management, Pharmacovigilance, and Clinical Operations. 
  • A proactive approach to risk management, with a track record of delivering high-quality clinical data on time and within budget. 
  • We prioritize recruitment within the EU and EEA, and currently do not support VISA applications.

This role is designed for a detail-oriented professional who excels in a dynamic environment and is eager to take on challenges in clinical trial programming. If you are driven by quality, efficiency, and the opportunity to advance cutting-edge pharmaceutical research, we encourage you to apply and join our team in pushing the boundaries of medicine. 

 

Why Merus?

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

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.