Associate Director Clinical Science

Job Title : Associate Director Clinical Science (Office or Remote)

Job Location : Brisbane CA USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Description

The Associate Director Clinical Science will be a key contributor to the scientific clinical and operational scope of clinical development programs with an emphasis on programspecific activities. The Associate Director Clinical Science will help 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 crossfunctional study management teams for the design execution and monitoring of clinical trials as well as data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department.

Responsibilities

• Partner with crossfunctional studylevel teams to help drive the conduct of our clinical studies including operational feasibility data management deliverables preparation of meeting materials communication plans safety monitoring preparation of status update reports and study closeout activities.
• Analyze clinical trial data including gathering analyzing reviewing interpreting and providing preliminary assessments. Assist in communicating a clear overview of trial results to program teams.
• Perform safety / efficacy data reviews. Will be responsible for assessing issues relating to protocol conduct and / or individual subject safety.
• Support senior team members with medical monitoring reports safety reviews site interactions and reviewing TFLs.
• Provide organizational support for Data Monitoring Committees and 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 clinical protocol synopsis and contribute to authoring of clinical study protocols 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 clinical trial objectives; responds to or triages questions for appropriate escalations.
• 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 site initiation visits.
• Conduct literature reviews as needed.
• Line management of junior clinical scientists.

Qualifications

Physical Requirements

Must possess mobility to work in a standard office setting and use standard office equipment including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person before groups and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access enter and retrieve data using a computer keyboard mouse or calculator and to operate standard office equipment. Positions in this classification occasionally bend stoop kneel reach push and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift carry push and pull materials and objects weighing up to 25 pounds.

This role can be based at our Brisbane CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $195000 $205000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including without limitation individual education experience tenure skills and abilities internal equity and alignment with market data. In addition to a competitive marketbased salary Arcus offers the opportunity to participate in stock programs a performancebased bonus and a comprehensive benefits package. Additional information about our total rewards program can be found here : .

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race religion color sex gender identify sexual orientation age nondisqualifying physical or mental disability national origin veteran status or any other legally protected status. EOE / AA / Vets

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Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Employment Type : Full Time

Vacancy : 1

Salary : $195,000 - $205,000