Senior Research Scientist - Toxicology - Camurus (Lund)

TOBLOR Consulting AB; Lunds kommun; On-site; SEK 900,000 - 1,100,000; Full time

Job summary

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines. In Lund you will join the Non-Clinical Development team and contribute to the toxicology strategy for Camurus' products, working closely with colleagues across disciplines and external partners.

This Senior Research Scientist role is strategic and cross-functional, responsible for developing non-clinical plans, designing GLP toxicology programs,

Qualifications

• PhD or MSc in Toxicology, Pharmacology or another relevant Life Science discipline.
• Several years of experience in non-clinical drug development and GLP toxicology studies; familiarity with outsourced development and regulatory requirements.
• Experience as Sponsor Monitor or Study Director is valued.
• Strong scientific writing skills with knowledge of regulatory documentation.
• Fluency in spoken and written English is required.

Responsibilities

• Develop toxicology strategies and non-clinical development plans.
• Design and monitor outsourced GLP studies.
• Select, manage and collaborate with international CRO partners.
• Prepare and review toxicology reports and regulatory documentation.
• Represent Non-Clinical Development in cross-functional development teams.
• Ensure compliance with GLP and international regulatory requirements (ICH, FDA, EMA and OECD).

Skills

Toxicology

Pharmacology

Regulatory writing

Study coordination

English proficiency

Education

PhD in Toxicology

MSc in Toxicology

Job description

Senior Research Scientist - Toxicology - Camurus (Lund)

Kommun: Lund

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn.

In this role, you will join the Non-Clinical Development team in Lund and contribute to the development of innovative medicines in a dynamic and collaborative environment. You will play a central role in the toxicological strategy for Camurus' products, working closely with colleagues across multiple disciplines as well as external partners.

We are looking for an experienced Senior Research Scientist, Toxicology to join our Non-Clinical Development team.

This is a strategic and cross-functional role where you will be responsible for developing non-clinical plans, designing toxicology programs and coordinating outsourced non-GLP and GLP toxicology studies performed by Contract Research Organizations (CROs). Acting as Sponsor Monitor, you will oversee study design, study conduct, data review and final reports, ensuring scientific quality, regulatory compliance and timely delivery. You will also contribute to regulatory submissions by preparing and reviewing non-clinical documentation and representing Non-Clinical Development in product development teams.

Main responsibility

Among others, your responsibilities will include:

• Develop toxicology strategies and non-clinical development plans.
• Design and monitor outsourced GLP studies.
• Select, manage and collaborate with international CRO partners.
• Prepare and review toxicology reports and regulatory documentation.
• Represent Non-Clinical Development in cross-functional development teams.
• Ensure compliance with GLP and international regulatory requirements (ICH, FDA, EMA and OECD).

Candidate profile

You hold a PhD or MSc in Toxicology, Pharmacology or another relevant Life Science discipline.

You have several years of experience from non-clinical drug development within the pharmaceutical, biotechnology or CRO industry. Experience of planning, monitoring or conducting GLP toxicology studies is essential, and you are familiar with outsourced development and regulatory requirements. Experience as a Sponsor Monitor or Study Director is highly valued.

You are an experienced scientific writer with solid knowledge of regulatory documentation. You are able to author the full range of non-clinical documentation, e.g. non-clinical overviews and summaries for regulatory submissions, and the non-clinical parts of the Investigator’s Brochure (IB). Experience of regulatory submissions is an advantage.

As a person, you are collaborative, structured and proactive. You enjoy coordinating complex projects, building strong relationships and working in a cross-functional, international and deadline-driven environment. Fluency in spoken and written English is required.

Camurus offers

This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market - and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other.

You will have a broad area of responsibility and drive multiple non-clinical programs, working closely with leading international CROs and cross-functional development teams. With your toxicology background you will have a crucial role in R&D related activities.

Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment.