This document is a job description for Lasse Eggers Pedersen as a Research Scientist at Novo Nordisk. It outlines his educational qualifications which include a PhD, MSc, or BSc in a relevant field as well as years of professional experience depending on degree.
The key responsibilities of the role include conducting bioanalytical assays and analyses for drug development projects, acting as a sponsor's monitor or study director on studies, developing and validating bioanalytical methods, and providing input to regulatory documents and meetings. The job requires coordinating bioanalytical aspects of development projects and communicating regularly with project teams and management.
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NOVO NORDISK JOB DESCRIPTION
Name: Lasse Eggers Pedersen
Dept. no.: 2431.04
Init.: LPDS
Dept. Name: Development Bioanalysis 4
Job title: Research Scientist (Job level B)
Immediate superior: Head of Development Bioanalysis 4
Qualifications (minimum requirements):
Education:
PhD or MSc or BSc in “relevant field”
Professional experience:
PhD with at least 0-2 years experience
within the areas of “relevant field”
MSc with at least 3-4 years experience
within the areas of “relevant field”
BSc with 5-7 years experience within
the areas of “relevant field”
Or equivalent knowledge through
relevant experience
Job content (purpose of the job) Stipulated
% of total
Key areas of responsibility:
Responsible for bioanalysis within development projects at Novo Nordisk
according to current assignments by supplying:
Scientific and project tasks
o Act as Sponsor´s Monitor on CRO studies (upon achievement of relevant
competences and approval by LOB)
o Act as Study Director on in house studies (upon achievement of relevant
competences and approval by LOB)
o Act as Principal Investigator or Contributing Scientist (upon
achievement of relevant competences and approval by LOB)
o Develop, set-up and validate bioanalytical assays for drug compounds,
biomarkers and/or drug metabolites
o Analysis of samples from non-clinical and clinical studies
o Reporting of bioanalytical data
o Design, plan and conduct state-of-the-art bioanalysis studies internally
or at CRO
o Participation in non-clinical team and clinical study/trial groups
o Prepare the bioanalytical part for safety evaluation
o Provide input to regulatory documents and meetings
o Provide input to Non-clinical Development plans (NCDP) and Exploratory
Safety Profile report, Clinical Development Plan (CDP) upon request
o Provide input to Design Review, Critical Decision and Safety Committee
meetings
o Share knowledge between projects
Department task:
o Participate actively in departmental meetings, seminars and working
85%
15%
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groups, e.g. cLEAN, e-voice action planning
o Contribute to implementation of new technology
Main job tasks:
Responsible for timely deliverables of high quality in accordance with the
project milestones as defined in Product Business Plans, Balance Score
Card and in line with the overall Novo Nordisk project portfolio priority
(key deliverables and critical activities)
Participate actively in non-clinical and clinical project teams
Responsible as contact and coordinator for all aspects of bioanalysis in
appointed development projects
Ensure continuous communication of data and progress of deliverables to
the NCPM
Ensure proper review and coordination of input to project documents
(e.g. Non-clinical Development Plan, IBs, IMPDs)
Ensure that project tasks are given priority, conducted and reported
according to customer needs
Provide regularly and upon request project activity overview to LoB and
inform LOB of critical issues.
Prepare and review reports and ensure that studies are properly finalised
and reported
Actively participate in scientific discussions within the department
Ensure compliance with relevant current regulations (GLP and GCP)
Continuously challenge that techniques used in the department are state-
of-the-art and contribute to timely implementation of new techniques to
meet future demands
Keep updated on bioanalysis by reading literature/attending scientific
meetings
Ensure good professional relationship with CROs and stakeholders
Ensure that the technician involved in the scientists current tasks get
timely and relevant information. In addition, a proper workload for the
technician must be ensured. Inform LoB if the workload is inappropriate.
Other individual assignments: -
Supplementary job description:
Level of Contribution
Often set directions and deliver results in own role which have a significant impact within
the context of a wider operational area (cross-functional area impact).
Often handle/responsible for complex scientific job tasks. Independently designs complex
protocols. Expert in optimisation/troubleshooting.
Drives complex reporting (e.g. study reports).
Independently plan and coordinate tasks in accordance with project plan and overall
objectives,. e.g. as cross-functional project task coordinator.
Independently function as key bioanalytical member in cross-functional project teams
e.g.: medical & science teams, due diligence teams.
Independently function as key bioanalytical member in cross-functional project teams
during registration of new drugs.
Level of Knowledge/ Independence
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Occasionally demonstrate subject matter expertise or often manages NCD issues in projects
typically covering several parts of the organization and/or an international scope.
Might mentor/coach more junior colleagues.
Primary supervisor for technicians, Master/PhD students and potentially Post docs if
relevant.
Monitor and capture trends and developments within relevant scientific field.
Often make and execute decisions within area of responsibility and with impact across VP
areas.
Communication skills
Often required to convince others with a divergent interest to accept new concepts,
practices and approaches.
Regularly involved in negotiation of agreements with external parties.
Often have international collaboration/interactions, e.g. Key Opinion Leaders.
Present complex interdisciplinary scientific issues at internal/external meetings and prepare
sections for regulatory applications.
Communicate to ensure efficient knowledge sharing and collaboration across areas (e.g.
GR, CMC, RA & GD).
Communicate and interpret complex scientific issues in relation to recommendation to
cross-organisational decision boards.
Level of Innovation and Complexity
Demonstrated ability to identify better practice and create improvements in methods,
techniques, approaches etc.
As an AKA often included in cross-functional projects and/or often requirement to work
internationally. The complexity of the projects can also demands high innovation to deal
with completely new situations and sometimes in an international context.
Recognized as an innovative person capable of identifying/implementing solutions within
complex projects and/or technologies.
Drive generation and evaluation of new ideas/ technologies.
Evaluate and implement state-of-the-art technology base.
Personal qualifications
Structured and overall overview capabilities
Ability to communicate professionally
Ability to take initiative
Ability and willingness to adjust quickly to new situations in a continuously developing
environment
Ability to work independently
Team oriented personality with high degree of flexibility
Sense of responsibility
Quality minded
Fluent in written and spoken English
Approval
This document is signed electronically in novoDOCS. Signatures appear on a separate page
4. Novo Nordisk A/S Electronic Signature Page
Documentum ObjectID :
This is a representation of an electronic record that was signed electronically and this page is the
manifestation of the electronic signature.
Document signed by:
Initials Full Name
Meaning Date and Time of Signature
(Server Time)
12 Apr 2016 06:08:57
LPDS Job Description
090239b78115ade9
psga PSGA - Pia Søndergaard Galle
Management Approval 11-Apr-2016 15:09 GMT+0000
lpds LPDS - Lasse Eggers Pedersen
Owner Approval 12-Apr-2016 06:09 GMT+0000