The Clinical Scientist will be a key member of the Clinical team with responsibilities to provide scientific support for clinical development activities, including implementation of scientific clinical strategy into trial design and coordination of clinical development activities related with clinical pharmacology. This role will be integral in facilitating successful and timely initiation and completion of the company’s clinical development programs.
The Clinical Scientist will collaborate closely with Translational R&D, program management, clinical operations, biostatistics, data management, regulatory, and business development (life cycle management), as well as externally with Clinical Research Organizations, Clinical Sites, and Clinical Investigators. Additionally, the Clinical Scientist will support the development of scientific external relationships with key therapeutic opinion leaders (KOLs) and provide clinical input into safety and regulatory interactions.
Extensive knowledge and hands on experience supporting clinical sciences in Oncology including clinical trial design, endpoint selection, statistics, clinical pharmacology, implementation of correlative studies, companion diagnostics, biomarkers, and ADA/Nab evaluation is required. Knowledge of clinical safety, immuno-oncology and mechanism of action of anticancer therapies, including biologics is preferred. Strong knowledge of drug development process, GCP, ICH guidelines and FDA regulations is highly desirable. The Clinical Scientist will be a self-motivated, creative, detail oriented, hands-on individual with the ability to formulate, develop, and support clinical trials while operating in a highly dynamic environment.
Duties and Responsibilities:
- Design clinical trials based on clinical data, regulatory guidelines, statistical analysis, company goals, reimbursement factors, commercial, and competitive landscape.
- Develop, propose, assess, and present different clinical strategy options. Assess risk/benefits of variations of the strategy. Create clinical development plans for various oncology indications, working as part of an integrated drug development team.
- Incorporate scientific input from the preclinical pharmacology team to guide the design of translational studies from Phase 1 to Phase 3.
- Support the completion of clinical trial documents including clinical protocols, investigator brochures, DSURs, and clinical modules of the IND.
- Provide input for the clinical database build, CRFs, monitoring plan, data management plan, and statistical analysis plan.
- Manage CRO engagements with respect to clinical pharmacology.
- Define biomarkers and/or clinical correlative studies that would support understanding and guide future development of the technology.
- Perform ongoing review of clinical data including review of draft tables/listings/figures to support data cleaning, analysis, and interpretation of study results. Proactively define questions to be addressed in the clinical data, and either perform the analysis or engage with the appropriate experts to do so.
- Provide scientific expertise to Clinical Operations and Biometrics by responding to questions or clarifying issues arising during study conduct.
- Lead review of study data (i.e., Tables/Listings/Figures and bioanalytical data) and development of Clinical Study Reports; prepare data for clinical presentations and scientific publications including posters, abstracts, and manuscripts.
- Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors.
- Prepare presentations, engage in discussions, record minutes and actions, and assess impact on the program plans through discussions with KOLs, advisory boards, consultant meetings and investigator meetings as part of life cycle management.
- Create a database on the competitive landscape and provide insights on strategic development pathways.
- Support the Business Development team providing clinical science expertise to evaluate and execute due diligence for the licensing or external assets or for the establishment of collaborations with other corporations.
- Proactively seek out and recommend process improvements.
- Anticipate potential study problems and prepare contingency plans as needed.
- Participate in Development Planning for assigned compounds.
- Aspyrian Therapeutics is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties.
Education and Experience:
- Advanced degree in life sciences (MD, PhD or equivalent).
- Minimum 5 years of experience supporting design, planning, executing, reporting and publishing of clinical studies.
- Strong scientific background in oncology with deep understandings of current pharmacological mechanisms of oncology drugs including immuno-oncology.
- Strong experience of clinical study design, including scientifically, medically and statistically appropriate endpoints.
- Up to date in new clinical trial designs in oncology.
- Robust understanding of clinical pharmacology to support PK, biomarkers, correlative studies and other studies integrate into clinical research protocols.
- Extensive experience in analysis and interpretation of clinical data, including the use of software packages to analyze clinical data.
- Understanding of the design and implementation of companion diagnostics for patient selection or to evaluate drug action.
- Understanding of clinical biostatistics.
- Comprehensive understanding of the drug development process in all phases of testing from Phase 1 to Phase 3 clinical studies.
- Experience with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
- Strong analytical and strategic thinking skills.
- Experience with interacting with clinical investigators and medical experts.
- Excellent oral, written, and interpersonal communication skills (fluency in written and spoken English is required).
- Ability and willingness to travel as needed.
Location: San Mateo, California
Department: Clinical Development
Min. Experience: Senior Level