Orion Corporation operates in more than 20 countries, where we Orionees, 3200 in total, work in all kinds of positions. Among us there are Research Scientists, Laboratory Technicians, Engineers and IT Specialists as well as people working in Production, just to mention some examples. We offer diverse and responsible jobs to our personnel in a truly multi-disciplinary work environment. We encourage people to develop their competences and offer opportunities to affect the job description and creating their own career path at Orion. We are searching for top talents who are ready to share our passion for the work that we do.

Description of position

As a Head of Translational Safety your strategic role will be to lead and develop the existing unit that is responsible for nonclinical safety of new drug entities from early discovery, through early (first-in-man) and late stage development (NDA/MAA). Your responsibilities include the following (but not be limited to):

• Designing, implementing, driving, and overseeing nonclinical safety related scientific strategies for portfolio assets
• Creating and driving a strategic scientific agenda that enables robust and efficient translational safety assessment
• Interpreting data from nonclinical toxicology studies, and best possible translation of the findings to the clinical setups
• Working with internal teams and external partners to execute on development objectives
• Contributing to development program strategy, study execution, interpretation of data and regulatory document preparation; review nonclinical safety pharmacology and toxicology summary documents
• Overseeing vendors and consultants as appropriate to execute on safety studies
• Advising project teams on nonclinical safety
• Leading the authorship for safety pharmacology and toxicology sections for regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.) and leading the resolution of nonclinical safety related interactions with drug regulatory agencies

The position has leadership and management responsibility for a team of about 15 experts working in safety pharmacology and toxicology (in vitro and in vivo). As a Head of Translational safety you will be responsible for the GLP compliance of regulatory safety pharmacology and toxicology studies.

Cross-functional communication within internal organisations in Orion as well as communication with external experts and academic and pharma partners will be a central component of your working field. Position is a permanent position and is situated in Orion Pharma R&D facilities in Espoo or in Turku.

Desciption of Unit

Translational Safety Unit is part of DMPK & Safety Sciences Department at Orion R&D.The Unit is responsible for the nonclinical safety assessment of new drug candidates (small molecules and also the other modalities) during various stages of the drug discovery and development process. The function designs and executes safety pharmacology and toxicology studies performed either in our own facilities (exploratory safety) or in collaboration with CRO´s (GLP studies).

We offer 

We offer exciting opportunities to create and have an impact on future therapies for patients. We also offer you a very interesting and challenging position, excellent team of strong professionals to lead and great colleagues to work with. Independence, accountability, support, trust, and lots of opportunities for development - of processes as well as your own personal skills.

In Orion we build well-being - together we do work that we are proud of! For more information, click here.

Requirements

We expect you to have relevant upper university level education (e.g. pharmacology, life sciences, veterinary medicine) and strong experience in the field of safety pharmacology, toxicology, preclinical in vitro and vivo research and also in pharmacology.

- PhD in Toxicology, Life Sciences, DVM or related field is required
- ERT/DABT certification is highly desired
- A minimum of 10 years’ experience in pharmaceutical or life science industry in a safety leader/expert role and proven track record of conducting safety assessment studies, and ability to make sound risk assessments.
- Direct experience developing the safety strategy and data package supporting the clinical development of small molecule and wide range of other modality (e.g. biologicals) therapeutics
- Track record of safety leadership on multiple programs at early and late stages of development
- Experience with EMA and FDA CTA/IND and BLA submissions and regulatory interactions
- Experience collaboration with DMPK, Regulatory Affairs, Clinical and  CMC colleagues to ensure comprehensive safety approaches are developed as part of the program strategy
- Ability to perform in fast-paced, dynamic, constantly evolving environment
- Excellent communication and organisational skills
- Strong time management skills; ability to prioritise multiple tasks efficiently
- A logical and independent mind
- Ability to provide novel solutions

Previous experience in supervisory duties is required. Existing leadership and management skills and ability to work collaboratively are highly appreciated.  Networking capability (internal and external) is essential for the successful management of the position. In addition, good communication and interaction skills will be considered as your advantage. Fluent written and spoken English is essential.

Additional information on the position 

Timo Lotta, Vice President, DMPK & Safety Sciences, on Thu 15th, Thu 22nd and Mon 26th April from 13-14, Tue 4th May from 15-16 and Thu 6th May from 14-15 from his mobile +358 50 966 4079.

If you are the person we are looking for, please submit your cover letter and CV via the link by 9th May 2021. 

#LI-ORION

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.