Senior Director/Vice President, Preclinical Research & Site Operations Lead

Job title:

Senior Director/Vice President, Preclinical Research & Site Operations Lead

Company

Work In Biotech

Job description

Summary
We are seeking an experienced and inspiring leader to join our Discovery team to drive the development of cutting-edge radioligand therapies for the treatment of solid tumors. Reporting directly to the CSO, you will oversee the design of translational strategies and collaborate closely with cross-functional teams, including Research, CMC, Clinical Development, and Regulatory Affairs, as well as external CROs to ensure their seamless implementation into our clinical trials.We are looking for someone who thrives in a fast-paced environment that rewards curiosity, humility and adapability. You will leverage their scientific expertise and a thorough understanding of drug development to lead our team and shape ARTBIO’s mission to bring Radioligand therapies (RLT) to patients.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

• PhD 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

About Us
ARTBIO is a clinical-stage radiopharmaceutical company redefining cancer care by creating a new class of alpha radioligand therapies (ARTs). The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for highest efficacy and safety. The company’s AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs with lead program AB001 currently in first in human trials. ARTBIO is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. For more information, visit , and follow us on and .As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.EEO Statement
ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

Expected salary

Location

Oslo

Job date

Sat, 26 Oct 2024 22:38:37 GMT

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