Associate Medical Director/Medical Director, Clinical Development

Location
Hayward, CA, United States
Posted
Sep 19, 2020
Ref
109
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overall Description

The Associate Medical Director/Medical Director, Clinical Development will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities. The Associate Medical Director/Medical Director, Clinical Development 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. This individual may also help support internal process improvement initiatives within the clinical department.

Job Duties and Responsibilities

Responsibilities may include, but are not limited to:
  • Partner with cross-functional program- and study-level teams with minimal oversight by senior clinicians 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 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; 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.
  • Conduct literature reviews as needed.
  • Line management of junior members of the clinical team.

Qualifications

Education/Experience:

  • At least 3 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role - title will be commensurate on experience.
  • MD or MD/PhD with experience in patient care at the graduate medical level and beyond.
  • 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.