Senior Clinical Project Manager_January 2023

Senior Clinical Project Manager


Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

KLIFO Clinical Operations Solutions (COS) ensures operational and strategic advise and support to our clients with tasks of varying complexity. Our team of highly skilled Project Managers work at our offices in Denmark, Sweden and Germany and manages global clinical phase 1-3 trials and medical device studies in multiple indications and therapeutic areas. In addition we also provide advise and sponsor oversight to a diverse segment of clients (pharma, biotech and medtech industries) and we work from the client´s office on occasions if required.

In the role as Senior Clinical Project Manager, you’ll contribute by:

  • Delivering clinical trial(s)/medical device studies as defined in the trial outline/protocol, to the agreed quality, budget, timelines and resources
  • Leading the clinical trial team(s), coordinate and manage all activities related to clinical trials/medical device studies
  • Communicating timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and COS management team
  • Possible participation in global development teams on compound level giving input to clinical development plans and operational strategies across a clinical program and taking on a main role in larger programs
  • Being mentor for Project Manager colleagues within COS

Your background and qualifications:

You have a positive, proactive, flexible and self-driven personality and like to work in a consulting environment with a high variety of tasks and responsibilities. Your communication skills and ability to listen to clients needs will be a substantial asset in the collaborations.

Furthermore, you have:

  • M.Sc./B.Sc. in the life science field and a minimum of 7 years in a similar position in the pharmaceutical industry/CRO
  • Extensive experience within clincial trial management and understanding the principles of clincial drug development incl. solid knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clincial trial processes
  • Ability to translate client´s need into a solid project plan
  • Ability to work independently without supervision of a colleague
  • Are skilled in supervising and coaching of non-senior personnel

Why join KLIFO?       

  • Join an organisation where we value people and their expertise as the greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry
  • Contribute with your expertise across different therapeutic areas
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked Senior Clinical Project Manager no later than 15th of March 2023. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Stefan Ingelsson, Team Manager at moc.ofilk@nosslegni.nafets or +45 44 226 345 for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Location

This position can be located in our office in Denmark, Sweden or Germany

Employment

Full time

Deadline for application

15 March 2023

Contact

Stefan Ingelsson
Team Manager
+45 44 226 345
moc.ofilk@nosslegni.nafets


About KLIFO   

  • 200+ employees
  • Offices in Denmark, Sweden, Germany and The Netherlands
  • Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug and device development consultancy with significant experience in partnering with biotech, pharmaceutical and medtech companies. We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.


Clinical Trial Assistant_January 2023

Clinical Trial Assistant


Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

KLIFO Clinical Operations Solutions (COS) ensures operational and strategic advise and support to our clients with tasks of varying complexity. In our Global Documentation team, 5 highly skilled CTAs/eTMF managers work at our offices in Denmark and Germany managing the TMFs, Clinical Trial Management Systems, study documentation and other administrative tasks to support management of global clinical phase 1-3 studies and medical device studies. In addition we also provide work from clients offices with TMF management and document oversight and support to sponsor teams if required.

In the role as Clinical Trial Assistant, you’ll contribute by:

  • Supporting the study team in the filing process and guiding in optimal setup of the TMF including preparation and review of relevant plans
  • Setting up and maintaining the TMF and Investigators Files
  • Performing periodic QC review and completeness check of the TMF
  • Supporting the Project Manager and the Clinical Research Associates in the management of clinical trials
  • Managing shipment/retrieval of study materials
  • Supporting the Project Manager in meeting organization

Your background and qualifications:

You have a positive, proactive, flexible and self-driven personality and like to work in the consultant environment with a variety of tasks. In addition, you are service minded and a collaborative team player with solid planning skills, attention to detail and is fluent in English, both spoken and written.

Furthermore, you have:

  • Preferably a minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within Business Administration, Librarian or equivalent will also be considered
  • Possess experience in management and filing of clinical trial documentation according to industry standards
  • Understand regulatory requirements, guidance’s, and industry standards that govern TMF practices
  • Possess excellent knowledge of GCP guidelines, medical terminology and clinical trial processes
  • Preferably have knowledge about the Veeva clinical vault system (eTMF and CTMS)
  • Ability to work independently without supervision of a colleague

Why join KLIFO?       

  • Join an organisation where we value people and their expertise as the greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry
  • Contribute with your expertise across different therapeutic areas
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked “Clinical Trial Assistant” no later than 28 February 2023. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Lykke Oldenburg, Team Manager, Global documentation at moc.ofilk@grubnedlo.ekkyl or +45 44422931 for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Location

Munich, Germany

Employment

Full time

Deadline for application

28 February 2023

Contact

Lykke Oldenburg
Team Manager, Global documentation
+45 44422931
moc.ofilk@grubnedlo.ekkyL


About KLIFO   

  • 200+ employees
  • Offices in Denmark, Sweden, Germany and The Netherlands
  • Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug and device development consultancy with significant experience in partnering with biotech, pharmaceutical and medtech companies. We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.


Clinical Research Director_JOB 231222

Clinical Research Director


Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

You will be part of a dynamic and well collaborating leadership team in an expansive and exciting company where we are working within different therapeutic areas for a heterogeneous client pool (pharmaceutical companies/biotech/investigators/academia). You will work in an interactive, flexible and trustful environment, where your competences and experience are highly appreciated along with the opportunity to develop even further among highly spezialised colleagues.

In the role as Clinical Research Director, you’ll contribute by:

  • Providing strong leadership of COS team and managing staff
  • Maintain and develop a positive client relationship with COS clients
  • Provide input to contracts and client proposals in collaboration with proposal managers
  • Contact to client, develop solutions, ensure delivery on contracts and generate re-sale to clients in co-operation with other business units
  • Ensure and demonstrate development of COS employees
  • Be self-driven in finding and improving organizational and procedural gaps and weaknesses

Your background and qualifications

You have strong leadership and organizational skills spiced with strategic thinking and planning. You are solution oriented and it is natural for you to motivate individuals as well as teams. You have the ability to listen and seek understanding of other points of view in both own team and client relationships. Your communication skills will also be a substantial asset in interactions with current and potential new clients.

Furthermore, you have:

  • M.Sc. in the life science field and at least 12 years’ experience in the CRO/pharmaceutical/biotech industry
  • 7-10 years of leadership experience
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, clinical trial processes and drug development
  • Deep understanding of business development and to perform work in accordance with agreed contracts
  • Experience in clinical project management, monitoring and document handling

Why join KLIFO?       

  • Join an organisation where we value people and their expertise as the greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry
  • Contribute with your expertise across different therapeutic areas
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Share your application

Share your application with us at moc.ofilk@boj marked “Clinical Research Director” no later than 18 January 2023. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Klas Rådberg, Vice President at moc.ofilk@grebdaar.salk or +45 44 222 935 for more information.

Location

Denmark, Sweden, Germany or The Netherlands

Employment

Full-time

Deadline for application

18 January 2023

Contact

Contact
Klas Rådberg
Vice President
+45 44 222 935
moc.ofilk@grebdaar.salK


About KLIFO   

  • 200+ employees
  • Offices in Denmark, Sweden, Germany and The Netherlands
  • Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug and device development consultancy with significant experience in partnering with biotech, pharmaceutical and medtech companies. We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.


KLIFO Controller_Job

Controller


Join an international drug and device development consultancy contributing with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

Our Controller team supports our 7 well-established service areas within all relevant financial disciplines in close cooperation with the rest of the Finance team. This includes sparring on financial topics with management, project controlling, monthly reporting, forecast, budgets and invoicing.

In Finance & Admin, we are a team of highly competent colleagues, including 5 controllers, proactively supporting management and project managers navigating the financial landscape within each service area.

You will report directly to the CFO and you will be located at our office in Glostrup together with the rest of the Finance & Admin team.

In the role as Controller, you’ll contribute by:

  • Acting as a strong business partner to the service area management and project managers
  • Controlling and continously having financial overview of projects and contracts
  • Manage monthly invoicing process
  • Prepare monthly reporting including analysis, comments and closing process
  • Prepare estimates in collaboration with management
  • Prepare analysis to support the yearly business plan and budget process
  • Financial sanity check of client contracts
  • Enable decision-making through Analysis, BI, presentations and xls models

You will also be involved in the development of finance related policies, BI and our upcoming Navision upgrade.

Your background and qualifications

You possess a collaborative mindset and enjoy working in a structured way with an eye for detail. You thrive just as well with daily hands-on work as with analysis on future business. You want to contribute to a culture of trust and transparency.

Furthermore, you:

  • Have experience as Controller preferably in a project-based organisation
  • Hold a relevant education such as cand.merc or HD
  • Thrive in a growing organisation
  • Are able to handle large data sets and complex information and turn this into overviews for decision making
  • Are comfortable maintaining a financial overview and communicate clearly with both Finance and Business teams
  • Are used to work independently, and come across as a dedicated team player who values collaboration
  • Are a strong user of Excel and BI, and have experience with Navision
  • Are fluent in Danish and English

Why join KLIFO?       

  • Join an organisation where we value people and their expertise as our greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked “Controller” no later than 25 November 2022. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Pia Riise, CFO, Finance and Administration at moc.ofilk@esiiR.aiP or + 45 44 22 29 00 for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Location

Glostrup, Denmark

Employment

Full-time, permanent

Deadline for application

25 November 2022

Contact

Pia Riise
CFO, Finance and Administration
+ 45 44 22 29 00
moc.ofilk@esiiR.aiP


About KLIFO   

  • 200+ employees
  • Offices in Denmark, Sweden, Germany and The Netherlands
  • Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug and device development consultancy with significant experience in partnering with biotech, pharmaceutical and medtech companies. We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.


Controller_JOB

Controller


Join an international drug and device development consultancy contributing with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

Our Controller team supports our 7 well-established service areas within all relevant financial disciplines in close cooperation with the rest of the Finance team. This includes sparring on financial topics with management, project controlling, monthly reporting, forecast, budgets and invoicing.

In Finance & Admin, we are a team of highly competent colleagues, including 5 controllers, proactively supporting management and project managers navigating the financial landscape within each service area.

You will report directly to the CFO and you will be located at our office in Glostrup together with the rest of the Finance & Admin team.

In the role as Controller, you’ll contribute by:

  • Acting as a strong business partner to the service area management and project managers
  • Controlling and continously having financial overview of projects and contracts
  • Manage monthly invoicing process
  • Prepare monthly reporting including analysis, comments and closing process
  • Prepare estimates in collaboration with management
  • Prepare analysis to support the yearly business plan and budget process
  • Financial sanity check of client contracts
  • Enable decision-making through Analysis, BI, presentations and xls models

You will also be involved in the development of finance related policies, BI and our upcoming Navision upgrade.

Your background and qualifications:

You possess a collaborative mindset and enjoy working in a structured way with an eye for detail. You thrive just as well with daily hands-on work as with analysis on future business. You want to contribute to a culture of trust and transparency.

Furthermore, you:

  • Have experience as Controller preferably in a project-based organisation
  • Hold a relevant education such as cand.merc or HD
  • Thrive in a growing organisation
  • Are able to handle large data sets and complex information and turn this into overviews for decision making
  • Are comfortable maintaining a financial overview and communicate clearly with both Finance and Business teams
  • Are used to work independently, and come across as a dedicated team player who values collaboration
  • Are a strong user of Excel and BI, and have experience with Navision
  • Are fluent in Danish and English 

Why join KLIFO:

  • Join an organisation where we value people and their expertise as our greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry 
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success 

Share your application:
Share your application with us at moc.ofilk@boj marked “Controller” no later than 18th November 2022. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Pia Riise, CFO at +45 44 222 900 for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


CTS Clinical Supply Manager_JOB

KLIFO is looking for a Clinical Supply Manager for our Glostrup office


Would you like to use your experience within the pharmaceutical industry to join our highly skilled Clinical supply department as Clinical Supply Manager?

We are growing and we need more dedicated colleagues to help us assist our highly valued and very professional clients.

The position:

As Clinical Supply Manager you will be working with a diversity of tasks from planning and coordinating clinical trials in close dialogue and cooperation with our clients. Preparation and approval of labels texts according to Annex 13/Annex VI, packaging materials, designs and blinding setups, coordinating return & destruction of IMP and cooperate with our distribution team in preparing distribution set ups.

You will also coordinate and collaborate with other CMO/CRO’s and ensuring a very highly quality level.

Qualifications:

The ideal candidate is a person committed to create and deliver solutions that meet individual customer needs.
Also, the person must have an independent, positive, proactive and flexible personality.
Our candidate is experienced with GMP and experienced within the pharmaceutical industry.
Fluent in written and spoken Danish is a requirement.

We offer:

As our new Clinical Supply Manager you will be part of an inspiring working environment in a growing
company. You will work with exciting customers among highly competent colleagues where your knowledge, experience and contribution is valuable and highly appreciated.

  • High job variation
  • High level of influence
  • Great social working environment and committed colleagues
  • A highly flexible, free and trustful culture

Location:

KLIFO has offices in both Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

Contact:
For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Manager at +45 44 222 986

Applications should be sent to: moc.ofilk@boj marked Clinical Supply Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 22 NOV 2022 (although applications are reviewed on an ongoing basis).

View job post as a PDF.


KLIFO JOB AD TEMPLATE_12092022

Regulatory Affairs Officer


Join an international drug and device development consultancy and contribute with strategic advice and operational support to clients based in Europe, the US and Asia.

At KLIFO, you’ll be part of a highly specialised team of experts who value workplace flexibility and collaborate to help our life-science clients across different therapeutic areas realise their unique projects.

Become part of an experienced and dedicated team

KLIFO Regulatory Affairs Solutions (RAS) ensures that expert regulatory advice and insight are embedded in our clients’ drug and device development projects. In RAS, we are a team of 15 highly specialised experts working across different regulatory areas to assist our clients in navigating the regulatory landscape. Our clients come from the pharma, biotech and medtec industries, and we work from client sites when required.

In the role as Regulatory Affairs Officer, you’ll contribute by:

  • Leading RAS projects from A-Z
  • Liaising with clients and competent authorities
  • Managing regulatory procedures
  • Preparing and submitting CTA and other regulatory documents, e.g. briefing packages, IMPD, IND, MAA/NDA, variations, renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Supporting projects in other departments based on your experience and skills

Your background and qualifications

You possess a collaborative mindset and work in a structured way with an eye for detail. You enjoy working within different thera­peutic areas and with tasks of varying complexity, and you thrive in a client-focused and supportive role. You want to contribute to a culture of trust and transparency.

Furthermore, you:

  • Have a M.Sc. in the life sciences field or RA specific diploma/master
  • Have a minimum 2 years of experience with regulatory affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Possess excellent knowledge of regulatory requirements and ICH-GCP
  • Have excellent communication skills (written and verbal)
  • Are fluent in German and English
  • Are an experienced user of Microsoft Office Package and good understanding of databases

Why join KLIFO?       

  • Join an organisation where we value people and their expertise as the greatest asset
  • Enter a flexible workplace with a culture based on trust, transparency and respect
  • Work with some of the most experienced and dedicated colleagues in the life-science industry
  • Contribute with your expertise across different therapeutic areas
  • Develop tailor-made solutions based on cross-disciplinary collaboration
  • Cultivate successful relationships with our clients
  • Be part of an organisation that sees knowledge-sharing as the road to success

Share your application

Share your application with us at moc.ofilk@boj marked “Regulatory Affairs Officer” no later than 15 September 2022. Interviews will be carried out continuously.

If you have questions about the position, please reach out to Anne Tingsgård, VP, Regulatory Affairs Solutions at moc.ofilk@draagsgniT.ennA for more information.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Location

Munich, Germany

Employment

Full-time, permanent

Deadline for application

1 October 2022

Contact

Anne Tingsgård
VP, Regulatory Affairs Solutions
moc.ofilk@draagsgniT.ennA


About KLIFO   

  • 200+ employees
  • Offices in Denmark, Sweden, Germany and The Netherlands
  • Headquarter in Glostrup, Denmark

KLIFO is a leading North-European drug and device development consultancy with significant experience in partnering with biotech, pharmaceutical and medtech companies. We provide end to end solutions and support our clients with strategic advice and operational support across therapeutic areas and disciplines.


DDC Project Director_JOB

KLIFO is looking for a Project Director for our office in Denmark


Would you like to use your extensive experience leading drug development projects in a consultancy business? KLIFO has an increasing number of biotech and pharma clients who are in need of strategic project leadership to effectively progress their drug development projects.

We’re looking for a new colleague to become part of our highly experienced team of Project Directors reporting to VP Drug Development Counselling and CMC, Hanne Wulff Nielsen.

We welcome your application if you are seeking new drug development and project leadership challenges and share our passion for understanding client’s needs and objectives.

The position:
The Project Director is responsible for leading and managing KLIFO clients’ development projects intended for EU, US and other markets within small molecules, biologics, Advanced Therapy Medicinal Products (ATMPs),  medical device and drug-device combinations.

You would become part of an international and growing company with a flexible and trustful working climate, respectful leadership and strong focus on and interest in people. We believe that our way of collaborating with each other and with clients is key to our success and we have therefore described it in KLIFO’s “Way of Working”, which we use in our daily work.

Your tasks would be to:

  • Lead development projects on behalf of KLIFO clients
  • Proactively identify strategic opportunities and needs for solutions and services
  • Identify and secure relevant competences within the project team
  • Ensure cross-functional collaboration and stakeholder management with the client and potential partners, within KLIFO and with external consultants
  • Serve as the single point of contact between KLIFO, the client and third parties
  • In collaboration with the line functions, prepare and negotiate proposals and commercial contracts
  • Prepare overall product development strategies and  plans and ensure team progressPrepare and facilitate risk assessments and gap analyses
  • Identify the need for and manage scope changes
  • Manage project budgets, estimates and reporting

Qualifications and requirements:

  • M.Sc. in life sciences and a minimum of 15 years of experience within pharma and/or biotech and 10 years of pharmaceutical drug development project leadership experience from preclinical to late stage
  • Extensive experience with international development projects in one, or preferably more, of the following areas: small molecules, biologics, Advanced Therapy Medicinal Products (ATMPs), medical device or drug-device combinations
  • High level of pharma business understanding preferably a business degree
  • Strong leadership and organizational skills with attention to details
  • Experience with stakeholder management at all levels, incl. senior and executive management
  • Experience with EU and/or US regulatory requirements, processes and agency interactions
  • Consultancy role and/or sales role experience is desirable
  • Experience with contracting or CRO/CDMO management is desirable
  • PhD in life sciences is an advantage
  • Excellent social and engagement skills
  • Excellent communication and presentation skills (written and verbal)
  • Local language and English, written and spoken at minimum at professional level
  • Travelling is limited, however, you should be willing to work from client’s sites

For you to thrive and be successful in this role you:

  • Enjoy contributing to many different projects
  • Seek solutions
  • Engage in to connecting with people and you listen to understand
  • Have a commercial mind-set
  • Maneuver respectfully and curiously in different cultures and with different stakeholders
  • Maintain the overview and have a systematic and pro-active approach to your work
  • Have a collaborative mindset and you are a flexible team player
  • Are comfortable with changing environments

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. You will be working out of our office in Glostrup, Denmark.

Contact:
For more information, please contact VP Drug Development Counselling and CMC, Hanne Wulff Nielsen:

moc.ofilk@neslein.ennaH

+45 4422903

 

Applications should be sent to: moc.ofilk@boj marked Project Director

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Senior Project Manager_JOB

KLIFO is looking for talented Senior Project Managers


KLIFO is expanding and wants to engage Senior Project Managers into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment with a positive, proactive, flexible and self-driven personality.

We offer a highly flexible, free and trustful working climate with very competent colleagues and exciting clients.

The position as Senior Project Manager:

The Senior Project Manager (SPM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines.
The SPM may take a main role in larger programs and can also have a mentor role for other employees within the Clinical Operations group:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team
  • Providing advice to clients within the areas of responsibility
  • May participate in global development teams on compound level giving input to clinical development plans and operational strategies across a clinical program

The qualifications of the Senior Project Manager:

  • BSc/MSc in the life sciences field or related discipline and a minimum of 7 years in a similar position in the pharmaceutical industry/CRO
  • Extensive experience within clinical trial management and understanding the principles of clinical drug development
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Experience with multi-country and multi-centre studies
  • Ability to translate client’s needs into a solid project plan
  • Ability to work independently without supervision of a colleague within the group
  • Ability to supervise and coach non-senior personnel within the group
  • Excellent communication skills (written and verbal) in English
  • Microsoft Office skills

We offer:

  • Work within different therapeutic areas and with 
tasks of varying complexity
  • Work with a heterogeneous client pool 
(pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment with highly competent colleagues

Location:

KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position can be located in any of our offices or be home-based.

Contact:

For more information, please contact Stefan Ingelsson, Team Manager, at 004544226345

Applications should be sent to: moc.ofilk@boj marked Project Manager

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: Applications are reviewed on an ongoing basis.

View job post as a PDF.


Project Director

Project Director


KLIFO is looking for a Project Director for our office in Denmark or Germany or Sweden

Would you like to use your extensive experience leading drug development projects in a consultancy business? KLIFO has an increasing number of biotech and pharma clients who are in need of strategic project leaderhip to effectively progress their drug development projects. 

We’re looking for a new colleague to become part of our highly experienced team of Project Directors reporting to VP Drug Development Counselling and CMC, Hanne Wulff Nielsen. 

We welcome your application if you are seeking new drug development and project leadership challenges and shares our passion for understanding client’s needs and objectives. 

The position:

The Project Director is responsible for leading and managing KLIFO clients’ development projects intended for EU, US and other markets within small molecules, biologics, Advanced Therapy Medicinal Products (ATMPs), medical device and drug-device combinations. You would become part of an international and growing company with a flexible and trustful working climate, respectful leadership and strong focus on and interest in people. We believe that our way of collaborating with each other and with clients is key to our success and we have therefore described it in KLIFO’s “Way of Working”, which we use in our daily work. 

Qualifications: 

  • M.Sc. in life sciences and a minimum of 15 years of experience within pharma and/or biotech and 10 years of pharmaceutical drug development project leadership experience from preclinical to late stage 
  • Extensive experience with international development projects in one, or preferably more, of the following areas: small molecules, biologics, Advanced Therapy Medicinal Products (ATMPs), medical device or drug-device combinations 
  • High level of pharma business understanding, preferably a business degree 
  • Strong leadership and organizational skills with attention to details 
  • Experience with stakeholder management at all levels, incl. senior and executive management 
  • Experience with EU and/or US regulatory requirements, processes and agency interactions 
  • Consultancy role and/or sales role experience is desirable 
  • Experience with contracting or CRO/CDMO management is desirable 
  • PhD in life sciences is an advantage 
  • Excellent social and engagement skills 
  • Excellent communication and presentation skills (written and verbal) 
  • Local language and English, written and spoken at minimum at professional level 
  • Travelling is limited, however, you should be willing to work from client’s sites

For you to thrive in this role you: 

  • Enjoy to contribute to many different projects 
  • Seek solutions 
  • Enjoy to connect with people and listen to understand 
  • Have a commercial mind-set 
  • Maneuver respectfully and curiously in different cultures and with different stakeholders 
  • Maintain the overview and have a systematic and pro-active approach to your work 
  • Have a collaborative mindset and are a flexible team player 
  • Are comfortable with changing environments 

Your tasks would be to:

  • Lead development projects on behalf of KLIFO clients 
  • Proactively identify strategic opportunities and needs for solutions and services 
  • Identify and secure relevant competences within the project team 
  • Ensure cross-functional collaboration and stakeholder management with the client and potential partners, within KLIFO and with external consultants 
  • Serve as the single point of contact between KLIFO and client and third parties 
  • In collaboration with the line functions, prepare and negotiate proposals and commercial contracts 
  • Prepare overall product development strategies and plans and ensure team progress 
  • Prepare and facilitate risk assessments and gap analyses 
  • Identify the need for and manage scope changes 
  • Manage project budgets, estimates and reporting

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. You will be working out of our office in Glostrup, Munich or Lund.

Contact:

For more information, please contact VP Drug Development Counselling and CMC, Hanne Wulff Nielsen: +45 44222903,moc.ofilk@neslein.ennah . If you want to meet one of your future Project Director colleagues and learn more about their experience working in KLIFO, then we’re happy to arrange for that. 

Applications should be sent to:

moc.ofilk@boj marked Project Director.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

We review applications and invite for interviews on an ongoing basis. 

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