Director, Clinical Science

Location United States
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: 21170
Published: 9 days ago
Expiry date: 01 May 2021

Location: Remote, USA

New permanently remote opportunity with a rapidly advancing immuno-oncology biotech!

My client is a growing clinical stage biopharmaceutical company focused on the discovery and development of a range of novel combination therapies targeting cancer. With multiple product candidates in the clinic across more than a dozen clinical studies in areas of high unmet need, this company is quickly progressing their best-in-class therapies which will significantly improve oncology developments. On top of cutting-edge science and technologies, the company is built upon inclusivity, positive leadership, and a shared passion towards the fight against cancer. Above all, they strongly value a collaborative and transparent culture and are looking for those who share those values. With excellent financial and scientific partnerships, you will be given the agility of an emerging biotech environment who are backed by support from their larger pharma partners. The Director, Clinical Science will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities.

Responsibilities:

  • Drive the design, planning, and implementation of study protocols for assigned investigational products and play a key role in supporting related regulatory activities.

  • 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.

  • Partner with cross-functional program- and study-level teams with minimal oversight from senior team members to oversee the design and conduct of clinical studies, including 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 with minimal oversight from senior team members. May be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results.

  • Provide organizational support for Data Monitoring Committees other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.

  • 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; responds to or triages questions for appropriate escalations.

  • Act as recognized clinical expert for assigned programs both within and external to Arcus.

  • 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.

  • Help support internal process improvement initiatives within the clinical department.

  • Conduct literature reviews as needed.

  • Line management of junior clinical scientists.

Qualifications:

  • Master/PhD degree in health science field preferred, or other relevant advanced degree in a health science field.

  • At least 5 years of experience at a pharmaceutical, biotechnology or CRO 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 reach out to Lucy Psaltis lucy.psaltis@rbwconsulting.com / 617.982.1238

Salary: On application