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