Associate Director, Clinical Project Scientist, Oncology
About The Position
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials. The following responsibilities will be demonstrated in varying degrees of participation and leadership: Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study; Develops clinical research protocols, study case report forms, informed consent; Develops the medical review plan to support the statistical analysis plan; Plays a key role in the medical review of the study data and assists in coding, analysis and documentation Validates and interprets results of phase II - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals Ensures team member adherence to clinical guidelines and safety procedures; Communicates detailed outcomes and results of research findings to relevant partners; Provides input in managing project budgets and projections; Serves as liaison to global clinical sites for medical questions related to the clinical research trial ; Presents study status at internal/external meetings, including investigator meetings and governance committees Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities Participates in/leads interactions with health authorities; Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies; Reviews and maintains correct standard operations, procedures and protocol
Requirements
- A Master’s Degree, Ph.D., Pharm.D., or a B.A./B.S. with commensurate exceptional clinical research experience is required.
- A minimum of 3 years of industry experience in Oncology.
- Significant knowledge of basic and translational research with an understanding of applications to cancer drug development is required.
- The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research is required.
Nice To Haves
- Clinical Evaluations
- Corrective and Preventive Action (CAPA)
- Drug Discovery Development
- Entrepreneurship
- Good Clinical Practice (GCP)
- Leadership
- Medicines and Device Development and Regulation
- Presentation Design
- Regulatory Affairs Management
- Relationship Building
- Research Documents
- Safety-Oriented
- Scientific Research
- Strategic Change
- Study Management
- Tactical Planning
- Technical Credibility
Responsibilities
- Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study
- Develops clinical research protocols, study case report forms, informed consent
- Develops the medical review plan to support the statistical analysis plan
- Plays a key role in the medical review of the study data and assists in coding, analysis and documentation
- Validates and interprets results of phase II - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
- Ensures team member adherence to clinical research guidelines and safety procedures
- Communicates detailed outcomes and results of research findings to relevant partners
- Provides input in managing project budgets and projections
- Serves as liaison to global clinical sites for medical questions related to the clinical research trial
- Presents study status at internal/external meetings, including investigator meetings and governance committees
- Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities
- Participates in/leads interactions with health authorities
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
- Reviews and maintains correct standard operations, procedures and protocol
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Time off of Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
