CareersLegal Notice © 2008 Genmab A/S
 Hot News
Careers » Career Opportunities 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
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.
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
|
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
|
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
|
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
|
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
|
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.
|
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.
|
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
|
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
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
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
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.
|
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
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:
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.
|
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:
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.
|
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:
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
|
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:
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
|
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
|
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
|
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:
Education:
Experience:
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
|
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
|
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
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.
|
|