This role is involved in the design, monitoring, and data analysis of the Company’s oncology clinical trials. As such, the Associate Director, Oncology Clinical Scientist is an important and visible member of the Oncology team. Key Responsibilities
Provide input to protocol design, provide oversight of clinical data (entry by sites, data completeness/accuracy working closely with ClinOps/Biometrics/Data Management teams), and support site and subject retention in clinical trials alongside the Medical Monitor(s)
Develop and maintain up to date slide presentations for internal meetings related to the clinical trial(s)
Ensure successful completion of documents (including protocols, investigator brochure, safety monitoring plan, site training materials, clinical study report, health authority responses, standard operating procedures, etc.) with cross-functional team members
Represent Clinical Development on study teams and cross-functional teams as appropriate or as delegated by the Medical Monitor(s)
Ensure consistent use of language and criteria across multiple oncology projects (including partner studies)
Ensure study integrity and track accumulating clinical data in real time
Analyse, evaluate, and support accurate interpretation and reporting of clinical data
Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
Able to mentor and manage clinical scientists or interns (assigned as direct reports) within Clinical Development
Collaborate with—and serve as a clinical research resource for—cross-functional colleagues to optimize product development
Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
Contribute to corporate strategic and organizational initiatives
Complete assigned tasks thoroughly, accurately, and on time
Adhere to rigorous ethical standards
Travel up to 20% domestically and internationally for scientific meetings
RequirementsKnowledge, Skills and Experience
Advanced degree e.g. Ph.D., Pharm.D., equivalent OR at least 8 years of relevant work with direct involvement in clinical trials
Strong track record of scientific and clinical inquiry
Understand statistical concepts and clinical trial design
Possess excellent communication skills (both written and verbal)
Learn quickly, follow complex directions under pressure
Multi-task while remaining organized and attentive to detail
Work hard, be a trustworthy and collaborative team player
Take initiative and solve problems of moderate complexity
Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
Lead both directly and by example
At least 5 years of experience with clinical trial design and execution
At least 5 years of pharmaceutical industry experience
Experience with regulatory submissions and interactions preferred
Estimated compensation 185-200K/year DOEBenefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid maternity leave
Paid paternity leave
Commuter benefits
Disability insurance
