Associate Director, Clinical Operations

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.

                                                                                                    

 

 

·       Ensures multiple Ph I-III clinical trials are executed within designated program budgets and timelines

·       Collaborates with cross functional colleagues to ensure timely delivery of assigned studies

·       Recruits, hires, and manages Clinical Operations resources to ensure optimal deployment across trials or projects

·       Support Clinical Operations resources in their professional development

·       May lead departmental Clinical process or operational initiatives

·       Reviews or contributes to Clinical Protocol, study plans, manuals, and templates

·       May contribute to Clinical Operations SOPs and/or governance documents

·       Provides problem-solving expertise to clinical trials, and monitors trial key performance indicators in an effort to ensure timely execution of milestones

·       May attend qualification, initiation, interim monitoring, and close-out visits.

·       Ensures all trials are conducted in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices

·       Ensures all trials are conducted according to budget, including monthly and quarterly forecasting in partnership with Finance

·       Mentors and manages junior Clinical Operations staff, as applicable

·       Occasional domestic US travel up to 25%, and internationally (on an “as needed basis”) in support of trial activities

·       Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices

·       BS/BA degree in science-related discipline; or,

·       Advanced degree in related discipline; or,

·       Certification in assigned area

·       Typically requires a minimum of Eight (8) years of related experience, contingent on education/training

·       Oncology experience is required

·       Extensive clinical operations knowledge and cross-functional understanding of global clinical trial methodology 

·       Exhibits ability to learn and apply foreign health authority regulations to the clinical trial/research process

·       Experience developing trial plans (eg, site monitoring, communication, issue escalation)

·       Knowledgeable in clinical database platforms, interactive response technology (IRT) applications and processes, and clinical supply logistics

·       Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally

·       Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques

·       Experience dealing with complexity and ambiguity; ability to collect, digest, and communicate information

·       Ability to communicate vertically and horizontally through multiple channels, motivate diverse teams, and foster cross-functional collaboration

·       Prior experience managing full-time and/or contract employees

·       Works on assigned problems of complex scope with analysis of situation or data required

·       Exercises judgment within defined procedures and practices to determine appropriate action

·       Builds productive internal and external working relationships

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

Day One is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.

 

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.