Exciting position in innovative Norwegian oncology company
- Arbeidsgiver
- Oncoinvent AS
- Stillingstittel
- Head of Clinical Operations
- Frist
- Snarest
- Ansettelsesform
- Fast
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
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.
- The holder of this position will be based at Oncoinvent AS, Gullhaugveien 7, 0484 Oslo. The position will report to the Chief Medical Officer.
Om arbeidsgiveren
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.
Nøkkelord
Klinisk forskning, Kliniske studier, Onkologi, Ledelse
Spørsmål om stillingen
- Kontaktperson
- Bjørn Fuglaas
- Stillingstittel
- Partner
- Telefon
- 90 77 57 52
Gullhaugveien 7, 0484 Oslo