Associate Director, Neurotoxicology/safety
il y a 1 semaine
**Associate Director experienced in Neurotoxicology/Safety Pharmacology**
Janssen Research & Development, a division of Johnson & Johnson's Family of Companies has opened up an excellent opportunity which can be placed at its primary site in Beerse, Belgium, or in Spring House, PA, USA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
We are seeking a highly motivated, independent and passionate Associate Director to join our multinational Global Toxicology & Safety Pharmacology (GTSP) group.
**Key Responsibilities**:
The responsibilities of the Associate Director include but are not limited to:
- Accountable for the overall quality and timely delivery of nonclinical GLP safety pharmacology packages of compounds in early development (post-NME), at our preferred CRO’s, and become the global lead for the nonclinical abuse liability assessments of CNS-active compounds and single point of contact to the project teams in late development.
- Participate on issue-resolution teams for de-risking off-target CNS side-effects through: investigation of the neuropharmacology, molecular pathways, toxicology findings, active engagement in scientific discussions and the shaping of strategies designed to support and inform on critical development decisions. Issues can include for eg. investigation of seizurogenic risk, drug-induced tremors, drug-induced abuse liability and suicidal behaviour.
- Have/develop an understanding of the mechanistic role of ion channel/GPCRs/transporters in the brain related to seizure/convulsion.
- Developing Toxicology/Safety pharmacology strategies for de-risking CNS issues early in development (pre-NME, FIH) based on compound data from a blend of internal and external studies, literature, active participation on projects, in collaboration with Neuroscience and other Subject Matter Experts.
- They will also have the possibility to work in close collaboration with in-vitro neuronal as well as in vivo scientists within GTSP and Neuroscience Discovery at Janssen.
- Understand the off or on target mechanisms of action and in-vitro to in-vivo translational relevance of models.
- Represents GSP at interactions with global regulatory authorities on the nonclinical abuse liability assessments.
- Acts as compound Toxicologist/Safety Pharmacologist for assigned projects in early and late development.
- Works independently, champions constructive cross-functional collaborations with both internal and external partners, and prioritizes workload in alignment with pipeline priorities.
- Advises on labeling compounds within the occupational toxicology/worker safety area.
- Actively participates in external working groups related to CNS topics (eg. HESI, IMI2, CCALC).
**Qualifications**:
**Qualifications**
**Education**:
Typically will have a DVM, MD and/or Ph.D. in Toxicology/ Neuropharmacology /Neurophysiology or related fields with post-doctoral experience and 6-12 years of pharmaceutical company experience.
**Experience and Skills**:
**Required**:
- Collaborative team spirit.
- Highly motivated, independent, curious nature and with a passion to learn and develop new hypotheses.
- Experience as a Study Director/Study Monitor conducting/supervising safety pharmacology studies under Good Laboratory Practice regulations.
- The ability to influence decision-making processes, think and handle issues towards resolution, and contribute to project teams and scientific discussions are required with prior experience in scientific data evaluation, integrated safety (pharmacology) assessment, and scientific writing.
**Preferred**:
- Experience representing nonclinical safety CNS toxicology/pharmacology on Project Teams is preferred.
- Experience with both small molecule and new modality safety is preferred.
- Experience in in-vivo epilepsy/seizure research would be advantageous.
- Some knowledge of surgical techniques, instruments, analysis: Physiological continuous measurement techniques (eg. EEG, neuro-electrophysiological measurements), telemetric techniques, data analysis, interpretation and reporting.
**Other**:
- Excellent written and oral English communication skills.
- 5% Travel - national or international is encouraged.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or p
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