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Oncoinvent AS Gullhaugveien 7 0484 Oslo Norway

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HSE Manager

Oncoinvent AS is looking for a HSE (Health, Safety & Environmental) Manager to lead the HSE effort at Oncoinvent and to further develop the HSE program and culture. The primary objective of the HSE manager is to ensure that Oncoinvent operates in a safe and compliant manner, both with respect to health and safety of its employees and the environment it operates.

This position is an exciting opportunity to work in an innovative and dynamic bio-technology start-up company, to further develop the HSE program and build on the solid HSE culture within the company. The company is performing both R&D, manufacturing and is working with radioactive substances which gives a broad spectrum of challenges. The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference for patients worldwide. The position will report to the Chief Executive Officer.

Scope

HSE and radiation protection aspects at Oncoinvent’s R&D- and GMP production facility.
Ergonomic aspects at Oncoinvent’s facility and offices.

Key responsibilities and work tasks:

Own, develop and maintain Oncoinvent’s HSE system including radiation protection procedures.
Establish measurable HSE and radiation protection goals together with Oncoinvent’s leadership.
Enforce compliance with Oncoinvent’s and Norwegian HSE and radiation protection procedures.
Facilitate HSE behavioral leadership.
Facilitate risk assessments and implement mitigating actions for relevant operations.
Work with Oncoinvent staff to improve and maintain HSE and radiation protection procedures.
Ensure that Oncoinvent staff is trained in all relevant HSE and radiation protection procedures.
Ensure that all HSE and radiation protection training is documented.
Work proactively together with Oncoinvent’s staff to avoid any HMS incidents.
With the CEO, report incidents to the relevant authorities (Health and Safety Executive, DSA).
Together with the CEO, liaise with regulatory authorities.
Support Oncoinvent during inspections and audits from regulatory bodies.
Support Oncoinvent in responding to questions from regulatory bodies.
Support production, QC and QA in the investigation and closure of deviations.
Support production, QC and QA in the implementation of Corrective and Preventative Actions (CAPA).

Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:

As a minimum M.Sc. or equivalent education or experience is a requirement.

Experience as a HSE responsible; preferably in a similar type of company or organization.

Experience with radiation and hazardous chemicals and experience with chemical laboratories or manufacturing is an advantage.

Fluency in English and preferably working knowledge of Norwegian.

The successful candidate has a demonstrated ability to deliver on challenging goal and have a systematic approach with relevant scientific competence. The ability to network, communicate- and perform team work well will be appreciated.

Location:
The holder of this position will be based at Oncoinvent AS facilities, Gullhaugveien 7, 0484 Oslo.

About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients. The Oncoinvent team consists of 32 employees and the company anticipates further growth.

In December 2017 Oncoinvent finished building a state-of-the-art manufacturing facility to produce drug product intended for use in pre-clinical and clinical trials. Clinical trials for Oncoinvent’s lead product, Radspherin®, started in 2020. For further details on Oncoinvent see www.oncoinvent.com. The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material for both patients and trial sites, as well as developing the company further.

The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of micro-metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of micro-metastatic cancer.

Application deadline: As soon as possible

Type of Position: Permanent

Contact: Any questions – please feel free to reach out to Bjørn Fuglaas at Gevirgroup AS (+47 90775752) for a confidential discussion.

Head of Clinical Operations

Oncoinvent AS is looking for a Head of Clinical Operations to lead the clinical research program at Oncoinvent and to further develop the clinical operations department. The primary objective of Clinical Operations Department is to drive the clinical development for Oncoinvent’ s lead product candidate Radspherin®, initiating new studies and delivering according to ambitious milestone plans for the product. The preferred candidate for the Head of Clinical Operations position should be able to proactively engage with internal and external stakeholders and be a key resource for advising on clinical strategy for the company.

This position is an exciting opportunity to work in an innovative and dynamic bio-technology start-up company and participate in the development of novel pharmaceuticals. Oncoinvent’ s lead product candidate Radspherin® is currently in first-in-human/phase I clinical trials, and the company plans to move the product into pivotal phase 2 trials in 2022. The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference for patients worldwide.

Key responsibilities:

Overall responsibility for all clinical studies conducted with Oncoinvent product candidate(s)
Development of a clinical strategy and clinical development plans in collaboration with the company’s CMO
Management of company’s relationships with KOL’s and PI’s in collaboration with the company’s CMO
Selection and management of Clinical Research Organizations (CROs) and other vendors
Accountability for assigned clinical trial budgets
Building and leadership of a high-performing team to successfully drive clinical studies in accordance with appropriate quality standards including International Conference on Harmonization /Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs) and other regulatory requirements as applicable
Responsibility for overseeing activities relating to intemal GCP audits and regulatory inspections of Oncoinvent sponsored studies
Leadership of all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals.
Development of clinical operations related SOPs

Qualifications and experience:
The holder of this position should have the following documented qualifications and experience:

As a minimum M.Sc. or equivalent education is a requirement.
Experience as a Head of Clinical Operations; preferably in a similar type of company and/or development stage products.
Experience with cancer drugs and/or experience with radiopharmaceuticals would be advantageous.
Fluency in English and preferably working knowledge of Norwegian.
A successful candidate has a demonstrated ability to deliver on challenging goals, have leadership skills and relevant scientific competence. The ability to network, have a systematic and strategic approach as well as being able to communicate well will be appreciated.

Location: The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo.

About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients. The Oncoinvent team consists of 32 employees and the company anticipates further growth.

Oncoinvent has built a Class B production and research facility for radiopharmaceuticals. The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material for both patients and trial sites, as well as developing the company further.

The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of micro-metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of micro-metastatic cancer.

Application deadline: As soon as possible

Type of Position: Permanent, Management

Contact : Any questions – please feel free to reach out to Bjørn Fuglaas at Gevirgroup AS (+47 90775752) for a confidential discussion.

Head of Regulatory Affairs

Oncoinvent AS is looking for a new Head of Regulatory Affairs to lead the regulatory department at Oncoinvent.

The Regulatory Affairs Department primary objective is to drive the secure product development for Oncoinvent according to required standards and deliver according to ambitious milestone plans for the products under clinical development.
The department should be able to proactively engage with internal and external stakeholders and be a key resource for advising on clinical and product development strategy for the company. Experience in working with CRO’s is important.
This position is an exciting opportunity to work in an innovative and dynamic bio-technology start-up company and participate in the development of novel pharmaceuticals. The company has its lead product candidate Radspherin® in first-in-human/phase I studies. Radspherin® is a radiopharmaceutical designed to treat peritoneal carcinomatosis originating from ovarian cancer and colorectal cancer as the first indications.

The candidates should be looking for the energy and enthusiasm in a start-up company with the ambition to make a difference for patients worldwide.
The candidate is a member of the Oncoinvent leadership team and reports to the CEO

Key responsibilities:

The main purpose of the Head of Regulatory Affairs position is to obtain and maintain authorizations for clinical trials and marketing of medicinal products developed by Oncoinvent in EU/EEA, USA and other markets targeted by Oncoinvent AS. This includes the following responsibilities:

Responsible for providing regulatory input to medicinal product development programs, such as requirements and guidelines for chemical-pharmaceutical, non-clinical and clinical development, and manufacturing.
Responsible to inform management about current and new, coming regulatory requirements applicable for medicinal products in development, manufactured and/or marketed by Oncoinvent.
Responsible for developing regulatory strategies and plans, including choice of administrative submission procedures and use of regulatory and scientific advice meetings with regulatory authorities.
Responsible for the compiling, collating and submission of clinical trial applications, scientific advice information packages and marketing authorization applications in cooperation with Oncoinvent personnel and external regulatory service providers.
Responsible for the contact with regulatory authorities for medicinal products, including response to questions and changes to application dossiers.
Responsible for the coordination of regulatory work with contract regulatory and clinical service companies and with license partners, as applicable.
Responsible for the maintenance of marketing authorizations for medicinal products, including preparation and submission of variations and changes.

Qualifications and experience:

The holder of this position should have the following documented qualifications and experience:

As a minimum M.Sc. or equivalent education is a requirement.
Experience as a Head of Regulatory affairs; preferably in a similar type of company and/or development stage products.
Experience with cancer drugs and/or experience with radiopharmaceuticals would be advantageous.
Be fluent in English and preferably working knowledge in Norwegian.
A successful candidate has a demonstrated ability to deliver on challenging goals and have deep relevant scientific competence. The ability to work well with others, have a systematic – and an analytical approach will be appreciated.

Location
The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo.

About Oncoinvent
Oncoinvent is a privately held Norwegian company based in Nydalen, Oslo. The company is committed to developing novel, innovative products to provide better treatment options for cancer patients.

The Oncoinvent team consists of 32 employees and the company is growing.
Oncoinvent has built a Class B production and lab facility for radiopharmaceuticals. The facility received a GMP certificate from the Norwegian Medical Agency in February of 2019. The approval provides the company with the necessary flexibility and capacity for manufacturing clinical trial material., as well as developing the company further.

The company’s lead product candidate Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of metastatic cancer.

Contact:

Please submit your written application describing why Oncoinvent and what you can contribute. Any questions – please feel free to reach out to Bjørn Fuglaas at Gevirgroup AS (+47 90775752) for a confidential discussion.