Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Associate Director of Clinical Science supporting clinical development of RazyeBio radiopharmaceuticals for oncology indications. Involves collaboration on clinical trial activities and document preparation.
Responsibilities
- Plays a supportive role in clinical development of RazyeBio radiopharmaceuticals for oncology indications.
- Responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area.
- Collaborates on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting.
- Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials 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, and prepares slides and other review and meeting materials.
- Addresses questions regarding scientific and related procedural issues from Investigators with MD supervision.
- 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 and anticipates moderately complex obstacles within a clinical study, implementing solutions with guidance.
Requirements
- PharmD or PhD preferred
- 6+ years of relevant scientific and/or drug development experience with a MS.
- 8+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field.
- 3 years experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization, or academic institution.
- 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.
- Proficient in GCP.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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