U.S. - Director, Clinical Research Scientist, Hem-Oncology

JOB DESCRIPTION: Associate Director to Executive Director, Clinical Scientist, Early Clinical Development As a Clinical Scientist within the Early Clinical Development Group, you will have responsibility and accountability for early clinical and clinical pharmacology programs and study implementation. You will have an unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including post-marketing activities. In this role, you will have the advantage of providing input into a breadth of products within and across your area of responsibility. We seek to provide a fun and rewarding career and a continuous learning experience. Essential Functions of the Job & Responsibilities Provide strategic leadership and demonstrating accountability for the clinical programs supporting early clinical development and clinical pharmacologyMaintain updated knowledge of competitive landscape on current assets or evolving standards of care for indications of interest and provide subject matter expertise on cross-functional project teamsAuthor/Review/Approve clinical protocols, analysis plans, study reports and regulatory submissions in collaboration with physicians, statisticians and other critical functions.Execute Clinical & Clinical Pharmacology studies in close collaboration with Clinical OperationsReview and summarize clinical safety or efficacy data in collaboration with the Medical MonitorWork closely with Quantitative Clinical Pharmacology, Translational Sciences and Statistics to develop protocols and summarize analysisContribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plansDraft and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissionsEnsure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical studies and programsDevelop and maintain collaborative working relationships with appropriate consultants and external experts for subject matter expertise and protocol developmentCompliant with departmental and broader organizational SOPs as fit for purpose, in compliance with current scientific standards and regulatory requirementsParticipate in project teams and serve as liaison to project teams, CRO's, Clinical sub-teams, and othersPresent data at scientific meetings, both internally and externally and author manuscripts in scientific journals Qualifications (Minimal acceptable level of education, work experience, and competency) At least 5 years’ experience and a, PhD, PharmD or MD degree or at least 10 years’ experience with BS/MS degree with emphasis on early development, clinical pharmacology or a related disciplineAbility to critically analyze problems and provide creative solutionsExcellent written and oral communication skillsConfidence and ability to present to and influence matrix teams and senior leadersAbility to work independently, manage multiple priorities, and thrive in a dynamic environment Genuine curiosity and drive to ask questions – looking for the ‘why’ of every projectExperience in clinical pharmacology, immunology or oncology is preferred, but not requiredWillingness to travel up to 20% or as business needs require, with accommodations available for individuals with disabilities Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.