Location: Remote, USA
This is an excellent opportunity for those interested in a flexible yet very hands-on role. You will be given the agility of an emerging biotech environment who are backed by support from their larger pharma partners. Their extreme success has come from utilizing precision combinations and immuno-therapies to advance a robust pipeline targeting the treatment of solid tumors. 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 cancer therapies which will significantly improve oncology developments. On top of cutting-edge science and technologies, they are driven by brilliant leadership and strongly value a collaborative and inclusive culture.
The Associate Medical Director/Medical Director, Clinical Development will report to the VP, Clinical development and work closely with both scientific and operations teams.
Contribute to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities.
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.
Oversee the design and conduct of clinical studies, with minimal oversight by senior clinicians, 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 senior clinicians. 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 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
Present at investigator meetings and scientific conferences.
Conduct literature reviews as needed.
Line management of junior members of the clinical team.
MD or MD/PhD with experience in patient care at the graduate medical level and beyond.
At least 2 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role – title will be commensurate on experience.
Experience in oncology or 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.
Professional and Personal Requirements:
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.
Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
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.
Ability to make independent, timely and appropriate decisions.
Please contact email@example.com for additional information.
Salary: On application
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