POSITION SUMMARY
Join our dynamic team as we lead the charge in developing innovative oncology therapies! In this role, you will spearhead the coordination and execution of multiple studies focused on pioneering biological and small molecules for first-in-human (FIH) trials, proof of mechanism (POM), early signs of efficacy (ESOE), and proof of concept (POC) studies in Oncology. Collaborating closely with the Global Development Lead (GDL) and multidisciplinary teams, you will be pivotal in crafting effective clinical development plans and ensuring timely study execution.
POSITION RESPONSIBILITIES
Partner intimately with the Global Development Lead (GDL) to define and execute the clinical development strategy for designated molecules and indications.
Provide scientific leadership, ensuring high-quality trial execution and innovative study designs while interpreting clinical study results.
Oversee the execution of programs from FIH through POC, ensuring clarity and effectiveness in trial processes.
Establish a robust clinical data review strategy, ensuring high-quality data management and presenting findings to governance bodies and stakeholders.
Collaborate with GDL, Clinical Safety, and Biostatistics to conduct thorough data reviews and analyses.
Act as a technical resource for clinical queries from internal and external partners, including investigators and consultants.
Assist in the creation of publications, abstracts, and presentations to disseminate clinical findings.
Contribute to key project milestones involving ESoE and POC trials by serving on project teams.
Lead the development and preparation of essential clinical documents, including protocols, clinical development plans, IND applications, and study reports.
Promote a culture of collaboration and trust across teams and therapeutic areas.
Coordinate with broader clinical research initiatives within Oncology Research Development and the Worldwide Research and Development organization.
Build effective partnerships with internal and external stakeholders, including clinical pharmacology, precision medicine, and regulatory affairs.
Work with Translational Oncology and Biomarker teams to integrate biomarker strategies into clinical programs.
Establish relationships with external experts and key opinion leaders to enhance study designs and facilitate recruitment.
Stay current with scientific literature in oncology and clinical development issues pertinent to the field.
Perform additional responsibilities as assigned within clinical programs.
Support departmental initiatives as assigned and contribute to functional priorities.
MINIMUM QUALIFICATIONS/KEY SKILLS
PhD or PharmD with at least 5 years of relevant experience, or an MS with a minimum of 7 years, or a BA/BS with at least 10 years in a similar role.
Proven clinical research experience in Phase 1 oncology studies from a sponsor perspective.
Deep understanding of oncology drug development, particularly in early phases.
Thorough knowledge of clinical procedures and regulatory guidelines (ICH, GCP, FDA, EMA).
Exceptional scientific writing and communication skills.
Experience authoring clinical documents such as protocols and regulatory submissions, coupled with a solid grasp of complex data analysis.
Documented scientific productivity through publications and presentations.
Familiarity with disciplines such as Clinical Operations, Safety, and Biostatistics.
A track record of building consensus and driving organizational change.
Experience in complex data listing and analysis.
A critical thinker, adept in collaborative and independent settings.
Proficiency in data analysis tools and platforms.
PREFERRED QUALIFICATION
Experience in leadership roles, fostering teamwork and mentoring colleagues.
This position requires you to perform complex data analyses and may involve travel (5-10%). Work Location Assignment: Hybrid.
The annual base salary for this position ranges from $169,700.00 to $282,900.00, with additional eligibility for a 20.0% bonus target and participation in stock options. Comprehensive benefits include health coverage, retirement plans, and generous leave policies. Relocation assistance may also be available based on business needs.
EEO & Employment Eligibility
Our organization is dedicated to fostering a diverse and inclusive workplace. We are an E-Verify employer and this position requires permanent work authorization in the United States.
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