Responsibilities

• Build and lead the Preclinical organization, including preclinical imaging, efficacy & safety, bioanalysis, translational biomarker strategy, toxicology, and quantitative pharmacology through a strategic combination of internal experience, external consultants, and CROs to achieve program and organizational goals while balancing resources
• Responsible for all EHS efforts for ARTOslo site as well as site agenda and resourcing prioritization
• Provide leadership, guidance, and mentorship to direct reports or team members, fostering a collaborative environment that encourages professional growth and development
• Develop IND/CTA-enabling preclinical data packages including non-GLP and GLP pharmacology, toxicology, pharmacokinetic/toxicokinetic studies to support project advancement to and through clinical development
• Collaborate with Clinical, Tech Ops and CMC groups to augment IND-enabling packages and translational plans for promising preclinical programs
• Provide strategic direction and oversight of the integrated translational science strategy for all pipeline programs to guide indication/patient selection, pharmacodynamic biomarker strategies, dose/schedule optimization and facilitate data-based decision making to inform and accelerate development
• Contribute to the authoring of relevant sections of clinical and regulatory documents, including briefing books, IND/CTAs, protocols and IBs,
• Provide tactical support to a multidisciplinary matrixed team executing translational activities across clinical programs, manage timelines and deliverables
• Identify and lead the evaluation, validation, and implementation of biomarker and pharmacodynamic assays at CROs for clinical use

Qualifications & Education

• Ph D or MD in a relevant scientific discipline (e.g. oncology, cell biology) with 12+ years of relevant experience in both small and larger pharmaceutical/biotech industry working with multi-/ cross-functional teams
• Experience with direct line supervision of multidisciplinary teams (10+)
• Track record of Development Candidate nomination(s) and R&D from LO through to IND/FIH
• Proven experience in developing and implementing biomarker strategies, including assay development, validation, and data analysis for oncology programs
• Strong interpersonal and problem-solving skills
• Capable of successfully planning, coordinating, and monitoring multiple projects
• Outstanding presentation and communication skills with the ability to grasp the big picture and influence to achieve desired outcome