Senior Clinical Trial Manager in Development Department
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Hørsholm
Are you passionate about clinical trial management and do you have the skills and knowledge to drive collaborations with clinical CROs, then we have an exciting opportunity for you at Gubra, as we are establishing a new position in Clinical Development as Senior Clinical Trial Manager.
As part of our small team, you will be able to influence and shape the job content in collaboration with the other members of the department. The development department consists of a cross-functional team that covers CMC-, nonclinical- and clinical-development, where you will report to the department manager. In addition, we work with external experts, consultants, and contract research organisations in a hybrid format to progress our projects.
Gubra was established in 2008 as a highly specialized preclinical CRO and biotech company focused on peptide-based drug discovery within metabolic and fibrotic diseases. As an addition to the drug discovery business, a new Development department was established in 2022, to further advance projects into early clinical development, which is where this position is based. The ambition for the department is to support an already strong discovery pipeline with clinical testing in humans for current and future projects.
As our new Senior Clinical Trial Manager, you will primarily be focusing on efficient conduct of one or more clinical trials, ensuring execution according to timelines and budget, optimise the collaboration with established CROs, experts and consultants and help identify and qualify new collaboration partners as required. In addition, you will also support other tasks in the department.
Your main responsibilities will include:
Professional qualifications:
To be a great asset to our team you will have:
A MSc degree in Natural or Health Sciences and 5-10 years of direct experience managing clinical trials for investigational drugs.
As a person you are a proactive, enthusiastic, and confident individual who can manage multiple tasks to meet personal and team goals. You are experienced in the operational execution of clinical trials and are known for your high performance, communication, presentation, and negotiation skills. You can build trust and consensus across professional and geographical boundaries. Finally, you are a team player that sees the value in reaching ambitious goals via a joint effort with the opportunity to grow along the way.
Application details
Please apply no later than November 19th, 2023, by uploading your motivated cover letter, resumé and relevant diplomas on our website. Please apply as soon as possible and note that applications will be reviewed on an ongoing basis. If you have questions about the position, please contact Department Manager, Stine Jørgensen at [email protected].
About Gubra
Gubra is an ambitious and innovative biotech company striving for excellence at all levels. We insist on doing things efficiently – and often differently - to reach the results we aim for. Our vision is to become leaders in the fight for a more sustainable and healthier world. We do that by facilitating the discovery of new medicine, and by acting and inspiring others to fight against the ongoing climate and biodiversity crises.
We have two primary areas of business: Preclinical contract research (CRO) services, and Proprietary early target and drug discovery programs. We are a biotech company delivering science to our partners and to our own research projects. We are active in the so-called pre-clinical space - before drugs are tested in humans - and generate our revenue by performing research for small and large pharma companies.
Our focus is within the metabolic space (obesity, diabetes, NASH (Non-alcoholic steatohepatitis), and diabetic complications), where we specialize in in vivo pharmacology, peptide chemistry, molecular pharmacology, histology, stereology, imaging, NGS (next generation sequencing), bioinformatics and biomarker assays. We work with some of the most interesting and loyal partners and customers from across the world within big pharma, biotech, and academia. Through a constant focus on high quality, scientific excellence, speed, and solid teamwork we have established ourselves as a highly professional and competent partner in the market.
People are our greatest asset, and our team consists of +210 employees all located in Hørsholm, Denmark. The mix of people from different cultures and educational backgrounds combined with our entrepreneurial mindset have greatly impacted our working environment, which is characterized by intensive drive, scientific curiosity, and teamwork – we join forces!
As part of our small team, you will be able to influence and shape the job content in collaboration with the other members of the department. The development department consists of a cross-functional team that covers CMC-, nonclinical- and clinical-development, where you will report to the department manager. In addition, we work with external experts, consultants, and contract research organisations in a hybrid format to progress our projects.
Gubra was established in 2008 as a highly specialized preclinical CRO and biotech company focused on peptide-based drug discovery within metabolic and fibrotic diseases. As an addition to the drug discovery business, a new Development department was established in 2022, to further advance projects into early clinical development, which is where this position is based. The ambition for the department is to support an already strong discovery pipeline with clinical testing in humans for current and future projects.
As our new Senior Clinical Trial Manager, you will primarily be focusing on efficient conduct of one or more clinical trials, ensuring execution according to timelines and budget, optimise the collaboration with established CROs, experts and consultants and help identify and qualify new collaboration partners as required. In addition, you will also support other tasks in the department.
Your main responsibilities will include:
- Plan, execute, and oversee clinical trials in alignment with project goals, plans, and regulatory requirements.
- Drive operational deliverables to the successful execution of clinical trials.
- Manage contracts with external collaborators.
- Ensure compliance with all relevant requirements and legislations.
- Communicate trial progress and issues to relevant stakeholders.
- Manage risks and resolve issues collaboratively with stakeholders.
- Promote best practices and consistency within the department.
- Contribute to Gubra´s clinical SOPs.
Professional qualifications:
To be a great asset to our team you will have:
A MSc degree in Natural or Health Sciences and 5-10 years of direct experience managing clinical trials for investigational drugs.
- Proven collaboration and stakeholder management skills.
- Capable to work independently and know when to inform stakeholders or when to ask for help.
- Experience in project execution and problem-solving and with a strong focus on quality and excellent planning abilities.
- Professional proficiency in English.
- Thorough understanding of GCP and relevant regulatory guidelines and knowledge of how to apply this to your work.
As a person you are a proactive, enthusiastic, and confident individual who can manage multiple tasks to meet personal and team goals. You are experienced in the operational execution of clinical trials and are known for your high performance, communication, presentation, and negotiation skills. You can build trust and consensus across professional and geographical boundaries. Finally, you are a team player that sees the value in reaching ambitious goals via a joint effort with the opportunity to grow along the way.
Application details
Please apply no later than November 19th, 2023, by uploading your motivated cover letter, resumé and relevant diplomas on our website. Please apply as soon as possible and note that applications will be reviewed on an ongoing basis. If you have questions about the position, please contact Department Manager, Stine Jørgensen at [email protected].
About Gubra
Gubra is an ambitious and innovative biotech company striving for excellence at all levels. We insist on doing things efficiently – and often differently - to reach the results we aim for. Our vision is to become leaders in the fight for a more sustainable and healthier world. We do that by facilitating the discovery of new medicine, and by acting and inspiring others to fight against the ongoing climate and biodiversity crises.
We have two primary areas of business: Preclinical contract research (CRO) services, and Proprietary early target and drug discovery programs. We are a biotech company delivering science to our partners and to our own research projects. We are active in the so-called pre-clinical space - before drugs are tested in humans - and generate our revenue by performing research for small and large pharma companies.
Our focus is within the metabolic space (obesity, diabetes, NASH (Non-alcoholic steatohepatitis), and diabetic complications), where we specialize in in vivo pharmacology, peptide chemistry, molecular pharmacology, histology, stereology, imaging, NGS (next generation sequencing), bioinformatics and biomarker assays. We work with some of the most interesting and loyal partners and customers from across the world within big pharma, biotech, and academia. Through a constant focus on high quality, scientific excellence, speed, and solid teamwork we have established ourselves as a highly professional and competent partner in the market.
People are our greatest asset, and our team consists of +210 employees all located in Hørsholm, Denmark. The mix of people from different cultures and educational backgrounds combined with our entrepreneurial mindset have greatly impacted our working environment, which is characterized by intensive drive, scientific curiosity, and teamwork – we join forces!
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 24.10.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
- Hørsholm
- Søndag den 19. november 2023
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