REPORTS TO (POSITION): Therapeutic Area Lead of Clinical Science
LOCATION: SOUTH SAN FRANCISCO, CA
DEPARTMENT NAME: Clinical Development
HR DESIGNATIONS: PAY STATUS – EXEMPT
Objective of Position
The Senior Clinical Scientist supports the Medical Monitor with oversight for the direction, planning, execution, and interpretation of clinical trials and related data collection activities. The Senior 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.
- May serve as a medical monitor for clinical trials of low complexity or provide support for medical monitoring activities on trials of increased complexity; including the oversight of all aspects of trial conduct, working closely with Medical Safety, Pharmacovigilance, Data Management, Quality, Regulatory and the study management team.
- 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.
- Excellent data analysis skills.
- Understanding of product and safety profiles.
- Proven ability to perform independently and with limited guidance.
- Demonstrated ability for critical thinking and 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 4 years 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 construed 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. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.