Director, Preclinical Research and Discovery
The Director, Preclinical Research and Discovery, leads the preclinical strategy for the lead asset and pipeline programs. This includes overseeing the preclinical research daily activities, team, and budget.
Our headquarters are in London and we are a remote-friendly employer. We have team members across countries in Europe and North America.
Roles and responsibilities
Lead the Preclinical Research and Discovery strategy for the lead asset and pipeline programmes
Oversee the Preclinical Research and Discovery daily activities, team, and budget including contingency planning
Generate new pharmacology data to required standards and build hypotheses for product development in relevant therapeutic areas, including sexual dysfunctions and mood disorders
Manage relationships with third parties to deliver on the strategy, including relevant contract research organisations (CRO), development/commercial partners, and academic centres
Review and oversee Preclinical submissions to and interactions with regulatory agencies including the FDA (US), the MHRA (UK), the EMA (EU), and the TGA (Australia) amongst others as relevant
Collaborate with Clinical Development colleagues, including the Chief Medical Officer and clinical operations, to design relevant clinical trials and protocols
Collaborate with Intellectual Property colleagues to identify and secure opportunities for IP arising from Discovery and Preclinical Research activities
Ensure preclinical studies are run in accordance with appropriate standard operating procedures (SOP) and relevant regulatory guidelines
Ensure the design of the nonclinical programme for the lead asset (and pipeline when relevant) is compliant with ICH requirements for the stage of development, facilitating efficient progress across phases
Maintain and apply Preclinical GxP and H&S knowledge to relevant activities, including through relevant trainings
Experience, skills and qualifications
Degree in Pharmacology or other appropriate scientific discipline, higher degree/postgrad qualification level strongly preferred (e.g. PhD)
Significant experience including in senior positions within Pharmacology and Preclinical functions of a pharmaceutical company or equivalent
Knowledge of relevant legislation and guidelines pertinent to preclinical drug development and pharmaceutical drug development
Relevant experience in scientific technical writing including for regulatory documents, grant submissions and scientific publications (published work preferred)
Experienced in presenting key data at national and international meetings
Competence in budgetary control and management
Proven organisational and time management skills
Strong problem solving skills
Experience leading, managing and developing others
Strong written and oral communication skills
Working knowledge of Excel, Word, PowerPoint, Endnote, search engines and databases used for literature searches, and relevant scientific software (e.g. GraphPad)
To apply, please send your CV to careers@kadencebio.com