Associate Director, Clinical Science

Role Summary

The Associate Director of Clinical Science plays a supportive role in clinical development of RazyeBio 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.

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.
• 20% of travel required.

Education

• 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.

Skills

• 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.