Senior Director, Clinical Science
Location | United States of America |
Discipline: | Medical & Pharmacovigilance |
Job type: | Permanent |
Salary: | £Salary: On application |
Contact name: | Lucy Psaltis |
Contact email: | lucy.psaltis@rbwconsulting.com |
Contact phone: | 16179821238 |
Job ref: | 21827 |
Published: | almost 3 years ago |
Expiry date: | 26 Jul 2023 11:59 |
Location: Remote, United States
My client is a fiercely growing oncology biotech who are making tremendous advancements with their current pipeline of clinical stage immune-oncology assets. This very attractive firm is partnered with large pharma and have received excellent funding to fuel their robust clinical pipeline and discovery portfolio targeting various solid tumors using combination therapies. With a strong value for work-life balance, all employees have the flexibility of working remotely from anywhere within the US, will receive an incredible benefits package and enjoy working in a collaborative and positive environment.
As the Senior Director of Clinical Sciences, you will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities. You will drive the design, planning, and implementation of study protocols for assigned investigational products and play a key role in supporting related regulatory activities.
Job Responsibilities:
Work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders
Operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities
Perform medical and related safety/efficacy data reviews
Responsible for analytical support of clinical trial data
Provide organizational support for Data Monitoring Committees
Author protocols and contribute to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents
Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives
Act as recognized clinical expert for assigned programs both within and external
Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications
Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders
Present at investigator meetings and scientific conferences
Conduct literature reviews as needed
Line management of junior clinical scientists and cross-functional team leadership within development
Qualifications:
Advanced degree in a health science field (Master/PhD degree in health science field, PharmD, MD or non-US equivalent)
12+ years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
Experience in oncology or oncology immunotherapy clinical trials preferred. Early drug development experience highly desirable.
Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.
Please direct all questions and applications to lucy.psaltis@rbwconsulting.com / (857) 273-1179
Salary: On application
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