Associate Director of Clinical Science

Bristol Myers Squibb•San Diego, CA

4d•$173,217 - $230,888•Onsite

About The Position

The Associate Director of Clinical Science plays a supportive role in clinical development of RayzeBio radiopharmaceuticals for oncology indications. Working in collaboration with clinical development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting, and potentially support of NDA/MAA filings.

Requirements

PharmD or PhD preferred
6+ years of relevant drug development experience with a MS.
8+ years of relevant drug development experience with a BS degree in Biological Sciences, health care, or a related field.
Minimum of 5 years’ experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization.
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire.
Knowledge of FDA, EMA and ICH regulations and guidelines a must.
Ability to effectively collaborate cross-functionally, across all levels of the organization.

Responsibilities

Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols.
Participates in protocol review discussions concerning scientific and procedural aspects of study design.
In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision.
Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans.
Reviews ongoing clinical data.
Organizes and oversees Data Review Committee meetings, including preparation of slides and other review and meeting materials.
With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators.
Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
Supports priorities within functional area.
Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions.
May be asked to coordinate teams and provide direction.
May lead two or more specific components of departmental strategic initiatives.
Able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
Leverage AI tools to enhance individual productivity and quality of work

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day