AD/Director Clinical Science
Proclinical is currently recruiting for an AD/Director of Clinical Science with a biopharmaceutical company located in San Francisco, CA. Successful candidate will drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will 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 by the Senior Director, Clinical Science 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 by the Senior Director, Clinical Science.
- Prepare and communicate a clear overview of trial results.
- Provide organizational support for Data Monitoring Committees other applicable data review committees.
- Author protocols and contributes 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.
Skills and Requirements:
- Master/PhD degree in health science field, PharmD, MD (non-US MD acceptable), or other relevant advanced degree in a health science field.
- At least 6 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
- Experience in oncology or immunotherapy clinical trials required. Early drug development experience highly desirable.
- Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.
- Ability to think strategically, innovatively, and tactically with an interest in clinical research and drug development.
- Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy. Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
- Excellent interpersonal, verbal, and written communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ella Jobson (+1) 646-868-5142 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.