Groundbreaking Biotech – Towards Better Treatment

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs.  Using cutting-edge antibody technology, Genmab's world class discovery, development and manufacturing teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders.  As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options.

Genmab's goal is to go all the way from biotechnological ideas to biomedical products. From research to patient we want to develop medicine that revolutionizes the treatment of cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions.

Genmab has over 500 employees in Denmark, the Netherlands, the United Kingdom and the United States who exercise their knowledge and skills in an inspirational environment with rapid business and development processes. We have the freedom to develop new ideas - and the conviction to pursue them. This creates a foundation for research, development and production which benefits all of our employees through high-level international partnerships combined with attractive salary packages including pension, insurance, health care and warrants.

Our Career Opportunities are listed by Geographic Location


Denmark

The Netherlands Career Opportunities

For all positions: You are offered excellent, competitive working conditions. If you want to become part of a dynamic, rapidly growing international company, and your ambitions lie within the area of immuno-therapy, please forward your application, stating the vacancy name, with full CV to:

Genmab BV,
Attn. Alwineke Bakker
Yalelaan 60,
3584 CM Utrecht
The Netherlands

or by e-mail to: A.Bakker@genmab.com - preferably as a Word-file.

Open Positions:

Research Technician, Translational Medicine

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Contribute to developing therapeutic antibodies

The Translational Research & Pharmacology department (TR&P) affects both research and treatment of patients in hospitals. We deal with setting up and performing “in vivo” models in order to test antibodies on therapeutic effectiveness. Besides that we perform translational research. The results of these research activities are used as a template for clinical studies/trials. The activities you perform are diverse: performing “in vivo” activities, preparing and implementing specific assays (ELISA, FACS, PCR, etc.) analyzing clinical samples and implementing new techniques.
You are a Research Technician with a Higher Laboratory Education (HLO) qualification. You are all-round and have the ambition to perform research that is very dense to the patient. You have an Article 12 license (required for this position) and preferably knowledge about immunology, cell biology and physiology. You are a good candidate when your goal oriented attitude and team working skills are combined with efficient and accurate working skills. Thereby you have a personal drive to increase your knowledge and skills, and your sense of quality results in frequent proposals for improvement of your work. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office.

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Judith Oprins, J.Oprins@genmab.com.
Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@Genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement

Research Technician, Molecular Biology (2)

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Contributing to increased understanding in molecular biology

The Molecular Sciences Unit is responsible for all molecular biology work within Genmab: from constructing expression vectors and setting up new technologies for antibody development to validating new antibody targets. This is established using a wide range of modern techniques in molecular biology, cell biology and protein biochemistry. These activities and associated recommendations are crucial for the development of new antibodies and technologies.
You cooperate intensively with scientists and Technicians in small project teams. You will be a Research Technician with a Higher Laboratory Education (HLO) qualification and have working experience in applying molecular and cell biology techniques. Any knowledge and/or experience of immunology or protein biochemistry will be an advantage. You will be enthusiastic, creative and will work efficiently and in an organised manner. You have the ambition to further develop yourself in molecular biology and to work together with colleagues on the development of new medicines. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office.

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Tom Vink, T.Vink@genmab.com. Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement

Research Technician, Analytical Chemistry

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.
 

Analyzing Genmab antibodies

The Protein Separations Department is primarily concerned with chromatographic separation techniques. The department purifies antibodies and other proteins produced at Genmab BV using column chromatography and analyses them using various different analytical HPLC- and MS- methods. Besides performing existing assays, you will work on setting up new techniques.
You will be an Technician with a Higher Laboratory Education (HLO) qualification and 1 to 3 years' work experience in biochemistry. You are experienced in performing HPLC analyses and, preferentially protein analyses. Knowledge of mass spectrometry or glycan analyses is an advantage. You will be a team player with your own contribution to make, and you will deal with your work quickly and in a structured way. You will also work accurately and document results reliably. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Gerrard Perdok, G.Perdok@genmab.com.
Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement

Research Technician, Immunology

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Contribute to developing therapeutic antibodies

As a Research Technician in Immunology you will be part of a project group. The activities vary from assay development to creative scientific research. As a Research Technician you will report directly to a Scientist.
You will be a Research Technician with a Higher Laboratory Education (HLO) qualification, and have ambition to develop yourself in the field of immunology and a desire to work on developing a new generation of medicines. A knowledge of and/or experience in the field of immunology, cell biology, molecular biology and protein biochemistry is desirable. You will be goal-oriented, enjoy working with others and be able to work efficiently and accurately. You will also be interested in learning and developing new skills. You will have a proactive attitude, setting high standards for quality, and you will make regular suggestions for how to improve your work. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Edward van den Brink, E.vandenBrink@genmab.com.
Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@Genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement

 

Scientist, Lead Identification

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Finding the leads
As a Scientist you will be part of the Lead Identification group in which you will work with colleagues and internal research groups to create our products. The work is focused on applying High Throughput screening Technologies for the developing of antibodies for therapeutic purposes and varies in practice from providing technical expertise relating to High Throughput screening assays and developing those assays. You will also be giving guidance on result interpretation. You will take care of the reporting of the assays and contribute to writing reports, scientific publications and patents. You will be a post-doctoral scientist with a wide knowledge and work experience in the field of HTS,  immunology, cell biology(Cell based asays) and wanting to put this knowledge to use in the development of medicines. You will have at least two years’ relevant work experience as a post-doc with developing cell based assays and databases including data capture and analysis preferably within a business environment. You will be results-oriented, thinking and acting with a focus on solutions and quality consciousness, and you will have a goal-oriented and team-focused attitude. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office.

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Arnout Gerritsen, A.Gerritsen@genmab.com.
Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement

Scientific Writer

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Science without lab work

The registration of new antibodies requires the relevant scientific research to be reported very clearly and completely. As a Scientific Writer you will be looking after the reading, thinking and writing phase of pre-clinical research, in close collaboration with the research team. In addition you will draw up summaries of the literature, provide support for the drawing up of patents and you will play a role in internal and external scientific communications. The Scientific Writer is immediately involved with the substantive scientific aspects of antibody development projects, without carrying out lab work themselves.
You will have wide experience in immunology or cell biology (you will have received your doctoral degree recently, or have at least three years’ research experience). You will have a passion for writing as well as experience of writing high-quality scientific documents. You will be focused on giving service and you will be a team player. You will have a flexible, positive attitude and excellent communication skills. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office.

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Sigrid Ruuls, S.Ruuls@genmab.com.
Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@genmab.com.
Agencies and other interested businesses are asked not to respond to this advertisement.

Laboratory Assistant

Genmab is a leading, extremely successful international biotechnology company working with a highly committed and enthusiastic team of managers, scientists and support staff to develop a new generation of medicines. The human antibodies Genmab develops are intended for use in the treatment of chronic and life-threatening diseases such as cancer, rheumatic conditions and infectious diseases. Due to the success of our company, a large increase in the number of medicines being developed and our expansion to a second location in Utrecht, a number of immediate job openings have arisen.

 

Supporting our lab work

As a lab assistant you and your fellow lab assistant will be part of the Facilities Team (5 FTE). You will ensure that our laboratories function properly. You will be responsible for collecting and inactivating lab waste from the different labs, using the destruction autoclave. You will also be responsible for receiving goods and distributing them to the different departments and locations, processing the details using the computer programme.

You will fill the nitrogen vessels, wash used lab glassware and ensure an adequate supply of clean lab coats. As a lab assistant you will carry out minor technical tasks. You will be approachable in dealing with people and you will have a service-oriented, flexible attitude. You will be handy, see for yourself what needs doing and be able to deal with work pressure and stress. You will have a Category B (passenger car) driving licence. Finally, you are fluent in Dutch, which is spoken in the office.

 

A dynamic and innovative environment

If you want to find out more about the job before sending your application, please contact Cora Frijters, C.Frijters@genmab.com

Genmab offers a pleasant, enthusiastic environment to work in, with excellent working conditions and good opportunities for personal growth and development. If you would like to be part of a very successful international biotechnology company, and if you enjoy working with lots of different enthusiastic and involved colleagues in producing great immunotherapy products, then send your application in, together with your CV, stating which post you are applying for, to Genmab B.V., Yalelaan 60,  Utrecht, for the attention of Alwineke Bakker. E-mail to A.Bakker@genmab.com.

 

Agencies and other interested businesses are asked not to respond to this advertisement.

Research Technician, Biochemistry

Biochemical determinations in a professional manner The unit Biochemical Analysis is responsible for the biochemical characterization of Genmab's antibodies and uses various immunological and biochemical techniques, such as nephelometry, electroforesis, and ELISA. Furthermore, immunochemical techniques are employed to conjugate antibodies and other proteins, and to prepare antibody fragments. The activities are carried out and reported according to standard operating procedures. We are searching for a technician with a B Sc degree and work experience at an immunological or biochemical laboratory. You have good communication skills, a service-oriented attitude and can handle varying and unexpected work load. You are accurate in your practical work and reporting of methods and results. As the various recurring activities rotate between colleague 5 technicians, we are searching for a real team player. 

 

Goal oriented team players You are a potential Genmab employee when your goal oriented attitude and team working skills are combined with efficient and accurate working skills. Thereby you have a personal drive to increase your knowledge and skills, and your sense of quality results in frequent proposals for improvement of your work. Finally, you are fluent in both English - our corporate language - and Dutch, which is spoken in the office.

 

Respond to this vacancy Mark your application with "Research Technician, Biochemistry" and send it to Alwineke Bakker at Genmab B.V., Yalelaan 60, 3584 CM, Utrecht, Nederland or via email to werving_en_selectie@genmab.com - preferably as a Word document. If you want to find out more about the job before sending your application, please contact Barbara Brpuwer / 030-2123123, B.Brouwer@genmab.com , or read more at www.genmab.com. A Dutch version of this vacancy is published on www.laboratorium.nl and www.bcfjobs.nl

United Kingdom Career Opportunities

Genmab is entering an exciting final development phase that includes further recruitment of key employees, especially within Clinical Development.  This is a unique opportunity to join the small enthusiastic team in the UK subsidiary.  With an attractive location outside London in Stevenage, Hertfordshire, we offer a friendly, supportive and sociable working environment.

Please mark your application with job title for each position and send it to:

Genmab Ltd.
Middlesex House
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
United Kingdom

Or by e-mail to: genmabltd@genmab.com

Open Positions:

Clinical Project Manager

Clinical Project Manager

 

Exciting Opportunity

Genmab is entering an exciting final development phase that includes further recruitment of key employees, especially within Clinical Development.  This is a unique opportunity to join the small enthusiastic team in the UK subsidiary.  With an attractive location outside London in Stevenage, Hertfordshire, we offer a friendly, supportive and sociable working environment.

 

Your Role

A new and exciting opportunity has arisen for an experienced Clinical Project Manager to work in collaboration with the Associate Director of UK Clinical Trial Operations.  You will be managing agreed Phase II and III clinical trials from start up to database lock.  You will also have Line Management responsibility for relevant Trial Team members.

Your role will include, but is not limited to the following:- preparation of ethics submissions or protocols and amendments, on-site monitoring and co-monitoring with Genmab and freelance CRA(s), telephone and online communication with Genmab staff and sites as required, training on trial documents, SOPs and literature and participation in any relevant Investigator and CRA meetings.

 

Experience/Attributes

You will have proven experience in a similar project management role, either from the biotect/pharmaceutical industry or CRO.  You will be educated to degree level in a relevant subject.  You are able to work independently and make decisions on your own with a positive attitude and good people skills, making it easy for you to interact with many different people.  You must also be competent and an experienced user of most MS Office programmes.

Clinical Research Associate

Clinical Research Associate 

 

Exciting Opportunity

Genmab is entering an exciting final development phase that includes further recruitment of key employees, especially within Clinical Development.  This is a unique opportunity to join the small enthusiastic team in the UK subsidiary.  With an attractive location outside London in Stevenage, Hertfordshire, we offer a friendly, supportive and sociable working environment.

 

Your Role

A newly created role for a CRA with proven monitoring experience is required to join the UK team.  In close collaboration with the Project Manager and other members of the trial team, you will ensure start up, recruitment and monitoring of agreed clinical trials within the Genmab portfolio in the UK.  All trials will involve monoclonal antibodies being tested in a wide variety of diseases.

Your role will include, but is not limited to:- preparation and submission of ethics submissions, preparation and collection of essential documentation, on-site monitoring, participation in relevant Investigator and CRA meetings and reporting of SUSARS.

 

Experience/Attributes

You will have proven experience in a similar role, either from the biotech/pharmaceutical industry, NHS or CRO.  You will be educated to degree level in a relevant subject.  You are able to work independently and make decisions on your own with a positive attitude and good people skills, making it easy for you to interact with many different people.  You must also be competent and an experienced user of most MS Office programmes.


 

Senior Clinical Research Associate

Senior Clinical Research Associate


Exciting
Opportunity

Genmab is entering an exciting final development phase that includes further recruitment of key employees, especially within Clinical Development.  This is a unique opportunity to join the small enthusiastic team in the UK subsidiary.  With an attractive location outside London in Stevenage, Hertfordshire, we offer a friendly, supportive and sociable working environment.

 

Your Role

A Senior CRA with proven monitoring experience is required to join the UK team.  In close collaboration with the Project Manager and other members of the trial team, you will ensure start up, recruitment and monitoring of agreed clinical trials within the Genmab portfolio in the UK.  All trials will involve monoclonal antibodies being tested in a wide variety of diseases.

Your role will include, but is not limited to:- feasibility studies, preparation and submission of ethics submissions, preparation and collection of essential documentation, on-site monitoring, participation in relevant Investigator and CRA meetings and reporting of SUSARS, training and mentoring of Junior CRA’s and acting as back-up for Project Manager in their absence.

 

Experience/Attributes

You will have proven experience in a similar role, either from the biotech/pharmaceutical industry, NHS or CRO.  You will be educated to degree level in a relevant subject.  You are able to work independently and make decisions on your own with a positive attitude and good people skills, making it easy for you to interact with many different people.  You must also be competent and an experienced user of most MS Office programmes.

New Jersey, United States Career Opportunities

Please mark your application with job title for each position and send it via mail to:

Genmab, Inc.
457 North Harrison Street
Princeton, NJ 08540
USA
Attn: Human Resources

Or via email to: careers@us.genmab.com

 

Open Positions:

Project Manager

Responsibilities:

  • Monitor study progress to assure compliance with protocol requirements, FDA regulations, Good Clinical Practices, ICH guidelines, and Genmab SOPs
  • Manage Phase I/II clinical trials in North America
  • Manage local study timelines in accordance with global timelines
  • Monitor and track patient enrollment and study/site progress
  • Collaborate with International Clinical Trial Manager to establish a working team atmosphere
  • Schedule and conduct team meetings and approve meeting minutes
  • Negotiate contracts and manage budgets
  • Review and approve contract CRA timesheets, vendor invoices, Investigator payments, etc.
  • Review draft protocols, ICFs and CRFs
  • Organize and conduct Investigators’ Meetings in collaboration with international team members
  • Identify, evaluate and select investigator sites in collaboration with local Clinical Trial Team
  • Pursue Regulatory Green Light (RGL)
  • Supervise study CRAs ensuring that the study monitors adhere to the study guidelines with regard to site management, data collection and query resolution and all protocol, CRF or other issues are resolved appropriately
  • Review Monitoring Reports
  • Review overall data quality issuing DCFs/resolve data queries as needed

Education/Experience:

  • Bachelors degree or equivalent required; Masters degree preferred
  • At least two years experience as a Project Manager in biotech/pharmaceutical industry

Knowledge/Skills: 

 

  • Ability to seek out potential problems and provide creative solutions to issues surrounding clinical operations (i.e., slow recruitment, site conflicts, etc.)
  • Good communication and leadership skills
  • Independent worker with ability to function in a team atmosphere
  • Knowledge of all aspects of running a clinical trial for phase I-IV.
  • Full knowledge of FDA regulations, ICH-GCP Guidelines, etc.

International Clinical Project Leader

Position Summary: 

 

Lead the worldwide clinical development of HuMax-CD-4 (zanolimumab), currently in Phase III development for the treatment of cutaneous T-cell lymphoma (CTCL) and in Phase II development for non-cutaneous T-cell lymphoma (NCTCL), and take it through the clinical development phase until registration in one or more indications.  Besides beings the clinical project leader, the position involves line management of operational staff.  This position will be based out of Genmab, Inc.’s Princeton, New Jersey office.


Responsibilities:

  • Act as the project leader for the clinical development of one or more products (HuMax-CD-4) within one or more therapeutic areas.
  • Define and update the clinical development plan (CDP) for a given product within a given indication involving Genmab colleagues within relevant professional areas.
  • Compile trial concept sheet (trial synopsis and rationales) for each individual trial in the CDP.
  • Interact with the Core Team, upper management and line management to ensure timely and ample information on the CDP.
  • Establish contact and interact with external experts to collect input, as needed, for clinical development plans and individual protocols.
  • Compile, update and follow up on the clinical project budget.
  • Ensure timely availability, proper resource allocation and quality of clinical trial protocols.
  • Provide input to relevant documents such as Clinical Study Reports, Investigator Brochure, applications to health authorities, annual safety reports, etc.
  • Act as line manager for International Clinical Trial Managers (ICTMs) and ensure that they are appropriately qualified and trained.
  • Perform other duties as assigned.

Qualifications: 

 

The following combination of education, experience and knowledge/skills are necessary to perform the duties of this position:


Education:

  • Bachelors’ degree or equivalent in life sciences or a related field; Masters degree preferred.

Experience:

  • Three plus years experience in a similar position with the health science industry.
  • Experience working with FDA and EMEA preferable.

Knowledge/Skills:

  • Excellent interpersonal, verbal, written and presentation skills
  • Outstanding organizational skill and the ability to motivate, organize and lead the team.
  • Demonstrated project management ability.
  • Team player with ability to collaborate with others to accomplish goals.
  • Ability to be flexible and positive. 
  • Proficient in use of Microsoft Office Suite.

 

Medical and Scientific Director

Position Summary: 

 

Medical Doctor to work as the Medical and Scientific Director out of Genmab's Princeton, New Jersey office that will have key impact on the local organization while maintaining a close relationship with colleagues in the Medical Department of Genmab in Copenhagen, Denmark performing highly-diversified tasks throughout the entire drug development process.  Additionally, this individual will provide medical input and support to the local Clinical Department during the preparation and organization of clinical trials and act as Medical Advisor throughout the trials.

 

Qualifications: 

 

The following combination of education, experience and knowledge/skills are necessary to perform the duties of this position:


Education:

  • PhD or Doctorate in Medical Science required

Experience:

  • Solid biological insight and clinical experience from a previous position at a university, a hospital and/or pharmaceutical industry
  • Experience in drug development is essential
  • Strong research background as reflected by publication listing

Knowledge/Skills:

  • Open to significant challenges in the development of groundbreaking biomedical products
  • Work independently and be responsible for successfully handling crucial issues relating to US clinical trials
  • Excellent communication and interpersonal skills
  • Outstanding organizational skills and the ability to motivate, organize and lead a team of colleagues
  • Ability to be flexible and positive

Drug Safety Manager

Responsibilities:


  • Data entry of SAEs including initial coding of SAEs reported during specific US trials
  • Regulatory compliance of SAE reporting to FDA
  • Facilitation of DMC meetings
  • CRA training
  • Assessment of listedness according to IB
  • Training internally
  • IND Annual Safety Reports in collaboration with CDS
  • Document management (coordination) of SOPs, Guidelines, Internal Working Documents
  • Perform other duties as assigned.

Education/Experience:

  • Bachelors' degree or equivalent and RN required
  • Two to four years experience within the biotech/pharmaceutical industry and safety required

Knowledge/Skills

  • Regulatory knowledge
  • Excellent communication and interpersonal skills
  • Good time management and organizational skills
  • Team player with ability to collaborate with others to accomplish goals
  • Ability to be flexible and creative
  • Proficient in use of Microsoft Office Suite

Clinical Trial Assistant

The Clinical Trial Assistant is a member of the local clinical team and assists the team to ensure effective study management and coordination of clinical trials.


Responsibilities:
  • Patient Tracking (this may include implementation of tracking procedures to document patient visits and overall study progress)
  • Design/implement study management tools
  • Compile regulatory documents and assemble/distribute regulatory packages (as well as Confidentiality Agreements and Clinical Trial Agreements)
  • Track incoming and outgoing regulatory documents
  • Recommend Regulatory Green Light
  • Filing of essential documents and maintaining the TMF (trial master file)/local TMF up to date
  • Track CRFs
  • Process Investigator payments
  • Organization and coordination of internal and external meetings (this includes taking minutes/preparing agendas)
  • Assist in organization of Investigators’ Meetings and participate, as needed
  • Make domestic/international travel arrangements and maintain travel file for Project Manager
  • Distribute trial-related materials to Investigator sites
  • Type correspondence/memos (e.g. using mail merge) and distribute
  • Initiate preparation and subsequent distribution of newsletter
  • Prepare ISF (investigator site file)/Pharmacy Binder for review by CRA/PM
  • Enter study and/or site information into the IMPACT system
  • Prepare study documents for import into document management system
  • Other tasks as delegated by team leader

Education/Experience:

  • Associates degree or equivalent required; Bachelors degree preferred
  • 1 – 2 years experience from similar work within a pharmaceutical company or CRO is preferable, but you can also be a research coordinator

Knowledge/Skills:

  • Good communication skills
  • Strong work ethic
  • Team player with a positive attitude
  • Excellent organizational skills
  • Proficiency with computer particularly MS Office

 

 

International Clinical Trial Manager

Position Summary:

 

As an International Clinical Trial Manager (ICTM), you will be responsible for leading global clinical trials with a fully human monoclonal antibody used to treat immunological diseases and specific types of cancer.


Responsibilities:

  • Overall responsible for the planning and conduct of a clinical trial
  • Establish and lead the trial team
  • Write the clinical trial protocol and other key documents
  • Participate in the CRF design and approve the final CRF
  • Provide clinical documents required for regulatory submission
  • Participate in the selection of CROs and central laboratories
  • Organize and present at Investigator’s meeting
  • Ensure that both internal and external parties are adequately trained in study specific procedures Coordinate monitoring and co-monitoring
  • Work closely with local project managers, CRAs and colleagues at HQ
  • Line manager for CRA(s)
  • The job requires some international and domestic travel

Qualifications: 

 

The following combination of education/experience and knowledge/skills are necessary to perform the duties of this position

 

Education/Experience:

  • Bachelor’s or Master’s degree in life science or RN with appropriate industry experiencE
  • 5+ years experience in the pharmaceutical industry and/or CRO
  • Proven ability to efficiently manage global clinical trials
  • Project Management experience preferable

Knowledge/Skills: 

  • The ability to work in a dynamic and flexible team environment is essential
  • Excellent organization and time management skills
  • Outstanding oral and written communication skills
  • Strong interpersonal skills
  • Attention to detail and follow-through
  • Experience in a supervisory role an asset
     

Food Services/Facilities Assistant

Position Summary:

 

Assist Food Services/Facilities Manager with food preparation, service and clean up in connection with an employer-sponsored lunch daily for employees and perform other tasks as needed with matters concerning the facility.

 

Responsibilities:

 

Food Services:

  • Prep and maintain the salad bar
  • Assist the manager when needed in lunch preparation
  • Help maintain a stocked line during service hours
  • Stock beverage coolers with soda, water and milk
  • Fill and maintain all coffee machines
  • Run dishwashing machine and three bay sink
  • Stock all dishes, flat ware and glasses
  • Make routine checks daily in both pantries and upstairs break room for dirty dishes
  • Able to follow standardized menus to cover for manager while out
  • Stock all snacks
  • Keep fruit display full and appetizing
  • Clean and wipe down all tables and chairs after service
  • Sweep and mop café and kitchen
  • Remove all garbage
  • Clean and sanitize kitchen equipment, prep tables and refrigerators
  • Sanitize all counter tops daily
  • Assist the manager with any and all jobs required to make the employee lunch as satisfying as possible
  • Assist in full break down and clean up of café and kitchen

Facilities:

  • Various repairs and replacements throughout the facility, i.e., changing ceiling tiles and lights, painting, hanging artwork, etc.
  • Provide support to employees with office moves, deliveries, etc.
  • Assist with miscellaneous projects as assigned

Qualifications:

  • The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent

Education:

  • High school diploma or equivalent required; Associates degree or equivalent preferred

Experience:

  • 1-3 years experience in food service required; 1-3 years facilities/handyman experience helpful

Knowledge/Skills:

  • Ability to interact at all levels both internally and externally
  • Good communication skills and professional image/presentation
  • Ability to perform multiple tasks simultaneously
  • Perform work priorities and activities with minimal supervision
  • Good time management and organizational skills
  • Team player with ability to collaborate with others to accomplish goals
  • Ability to be flexible and creative
  • Must be able to lift up to 50 lbs.
  • Knowledge/use of Microsoft Office suite including Word and Excel

Clinical Research Associate

Responsibilites:

 

Monitor assigned investigational sites ensuring adherence to Genmab SOPs, ICH-GCP guidelines, FDA GCP regulations and other applicable guidelines. This includes, but is not limited to, the timely completion of the following tasks:

  • Serve as primary contact for assigned investigational sites
  • Assist in the recruitment of investigational sites
  • Assist in the preparation and review of regulatory packages to be distributed to selected sites
  • Prepare Institutional Review Board submissions
  • Conduct pre-study, initiation, routine monitoring and close-out visits to investigational sites
  • Assist in maintenance of in-house files
  • Maintain and update Investigator files
  • Assist in organization and conduct of Investigator’s meetings as well as other relevant meetings
  • Generate and resolve data queries
  • Follow up on serious adverse events
  • Ensure that all current information about site status and patient status are captured in-house or in the electronic files
  • Review ISF (investigator Site File)/PSF (Pharmacy Site File) before submission to Investigational site
  • Write site visit reports
  • Use IMPACT’s monitoring portal
  • Enter info into and maintain clinical tracking database
  • Review of draft and final ICF (Informed Consent Form)
  • Ongoing training of sites, as needed
  • Participate in audits
  • Assist in response to audit findings
  • Other duties as delegated

Education/Experience:

  • Associates desgree or equivalent required; Bachelors degree preferred
  • At least one to two years experience as a CRA in the pharmaceutical industry or CRO

 

Knowledge/Skills:

  • Ability to work independently but also in close collaboration with a Project Manager and other team members
  • 50% travel across the US and Canada
  • Thorough knowledge of ICH-GCP and FDA regulations relating to clinical trial conduct

 

 

 

Minnesota, United States Career Opportunities

Please mark your application with job title for each position and send it via mail to:

Genmab MN, Inc.
9450 Winnetka Avenue North
Brooklyn Park, MN 55445
USA
Attn: Human Resources

Or via email to: d.kahl@genmab.com

Open Positions:

SAP Basis and Security Specialist

Position Summary:

 

As part of the SAP team, the SAP Basis and Security Specialist will be responsible to perform Basis and Security functions that include application support, monitoring and tuning, planning, designing, managing existing SAP ECC 6.0 environment including BI, Portals and Solution Manager as well as administration and maintenance of security across the SAP landscape.

 

This position reports to the SAP Sr. Business Analyst and works directly with business users and other team members to provide solutions for SAP issues.

 

Essential Functions:  

  • Designs, monitors and reports on security-related issues with an emphasis on maintaining the overall SAP security infrastructure.
  • Performs system refreshes across the SAP landscape which includes database refresh, client copy and system copy.
  • Maintains the integrity and quality of production system through operational procedures.
  • Ensures systems are maintained at the highest level of support plan, set procedures and provide reliable and secure system for business applications.
  • Designs and configures SAP security roles, maintains SAP user IDs and access rights assigned to roles.
  • Performs SAP Basis & Authorization administration and technical tasks including SAP profile parameter changes, system error analysis and security monitoring.
  • Implements SAP change control process & procedures.
  • Works with SAP and other software/hardware vendors to resolve problems.
  • Participates in design solutions, architecture recommendations, and strategies for continuous improvement.
  • Provides technical support for SAP production issues/escalations.  

Education and/or Experience:

 

Required Skills:

  • Bachelors and/or a Masters degree in Engineering or Computer Science or related discipline.
  • 8+ years overall IT experience.
  • 4+ years SAP Basis and Security experience.
  • Solid knowledge about SAP ECC landscape architecture, network, backup and hardware.
  • Good understanding of SAP Single Sign-on.