Reports To (Position): Therapeutic Area Lead of Clinical Science
Location: South San Francisco
Department Name: Clinical Development
HR Designations: Pay Status – Exempt
Objective of Position
The Clinical Scientist supports the Medical Monitor with oversight for the direction, planning, execution, and interpretation of clinical trials and related data collection activities. The Clinical Scientist requires limited oversight and review by the Medical Monitor.
Essential Duties/ Responsibilities
- In collaboration with study team, contributes to protocols, clinical study reports, IBs, ICFs, training documents, CRFs and other clinical and regulatory documents.
- Contributes with Clinical Operations and Data Management in database development, data review and querying.
- Protocol implementation including site identification and communication, attendance at investigators’ meetings, correspondence with sites including IRBs, and interaction with operation’s teams.
- Cross-functional interaction with all of the disciplines necessary for successful study implementation: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, and clinical operations.
- Data compilation for efficacy and safety evaluation.
- Work closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
- Key clinical representative in cross-functional sub-team meetings.
- Preparation of abstracts, posters, oral presentations, manuscripts and clinical study reports.
- Contribute to the preparation for development advisory boards, as needed.
- Represent the company at congresses and investigator meetings, as needed.
- Experience in developing study protocols and conduct/reporting of clinical studies in accordance with ICH/GCP and other relevant guidelines and regulations.
- Experience with database development, design of data collection tools/reports, data review and querying.
- Understanding of product and safety profiles.
- Demonstrated attention to detail.
- Demonstrated effective oral and written communication skills.
- Demonstrated ability to work well in a team environment.
- Ability to work well in a fast-paced, dynamic environment.
- Ability to travel (approximately 10%) to investigative sites, regulatory agencies, and to attend major oncology meetings.
- Advanced science/clinical degree (MD, MSN, PharmD, PhD, etc) required
- Minimum of 1 year of experience in clinical development, preferably in oncology and/or hematology preferred.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.