Preclinical Safety Expert
Vor 7 Tagen
Permanent Position - 100 % - GENEVA - CH
The Company
STALICLA is an international and fast-growing biopharmaceutical company on a mission to
build a new therapeutic space for patients with disorders of the developing brain. As the
company is rapidly scaling, STALICLA is looking to recruit a seasoned and agile PreClinical
Safety Expert to support the next stages of the company’s development.
The role
STALICLA is expanding its team and is opening a Preclinical Safety Expert Position. Reporting
to the Chief Medical Officer, he/she will be Responsible for the progression of small
molecules and combination of molecules for regulatory submission.
Your Responsibilities
- Responsible for designing and coordinating efforts including:
- Development of preclinical safety study program
- Design and conduct of preclinical GLP (and non GLP) safety and toxicology
studies at CRO as scientific study monitor (including selection, management,
cost control, study logistics initiation and closure)
- Interpretation of toxicity and safety pharmacology studies
- Ensure creation, review, maintenance, distribution, and archiving of studyrelated documents.
- Communication of results to project team and management
- Provide key contribution to hypotheses generation and drive the scientific strategy for
toxicology issue resolution in development projects.
- Responsible for authoring of non-clinical document sections for regulatory documents
(including, INDs, CTAs, IB)
- Close interaction with multidisciplinary team
- Ensure high scientific standards and adhering to requested timelines and budget in all
aspects of the position
Campus Biotech Innovation Park | Avenue de Sécheron 15 | 1202 Genève | Switzerland |
+ 41 22-545-12-42
**Profile**:
- PhD in toxicology, pharmacology, immunology, veterinary medicine, or related
disciplines
- At least 3-5 years of relevant industry experience in early and late-stage drug
development projects, preferentially as the Preclinical Safety Project Team
representative
- Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements
for pharmaceutical development of biotherapeutics and small molecules
- Experience as a GLP Study Director and/or as study monitor for studies at contract
research organizations (CROs) would be preferred
- Experienced in the preparation of regulatory documents for submission to health
authorities
- Excellent verbal and written communication skills and proven ability to collaborate
transversally in a global organization
- Strong team player with desire to contribute in a highly dynamic, professional, and
growing biotech team
- Strong interpersonal, communication, presentation, reporting and negotiation skills
- C1 level in English (verbal and written communication) mandatory
More about STALICLA
Ready to join a science-driven, international, multidisciplinary, passionate, hard-working, and
meritocratic environment?
STALICLA is suited for individuals with a strong interest in Precision Medicine and
Neurodevelopmental Disorders field, as well as the ability to go above and beyond to make
things happen
As part of its Corporate Social Responsibility policy, STALICLA promotes diversity, inclusion
encouraged to apply.
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