Associate Director/Director, Clinical Sciences, Oncology
LOCATION: South San Francisco
DEPARTMENT: Clinical Development
DIVISION: Clinical Development
REPORTS TO: VP, Clinical Operations
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages.
Effective Date: February 2021
The Associate Director/Director, Clinical Sciences is a key cross-functional team member contributing to the design and execution of Day One’s clinical trials. The Clinical Scientist is responsible for generating, analyzing, and interpreting study data (trial and individual patient level) and translating clinical data across and within the programs and studies. They also ensure that all studies are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies. This team member will provide expertise to internal teams (CMC, clinical operations, regulatory affairs, non-clinical, medical writing, biometrics, and pharmacovigilance) and external teams (CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met.
The Associate Director/Director, Clinical Sciences will work closely with the Chief Medical Officer and VP of Clinical Development to ensure the integrity and success of Day One’s clinical trials. Open, effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization). Thorough understanding of the drug development process from pre-IND through registration and post-registration is required. Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have strong work ethics and be able to work independently and productively. Must be willing to travel up to 25%.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Contribute to the design, implementation, and review of clinical protocols and study reports for scientific and operational accuracy
- In collaboration with Clinical Operations and other groups, contribute to the design, start-up, execution of the clinical studies for a product candidate
- In collaboration with Clinical Operations and Biostatistics, you will be responsible for timely delivery of high-quality clinical study data analysis and presentation. You will have opportunities to present clinical study results to cross functional teams, company leadership, and external stakeholders
- You will work closely with study investigators to ensure timely and high-quality execution of clinical studies and work with KOLs to review scientific and clinical data in order refine and advance clinical development strategy
- Ability to understand, interpret, integrate, and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms and apply this knowledge to support a robust clinical development strategy
- Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver timely enrollment. You may perform site monitoring with field teams, as needed
- Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, and CSRs
- Assist with the development of study presentations, handouts, and coordination of Investigator Meetings
- Analyze data and assist in writing for publications and scientific presentations
- In cooperation with Clinical Operations and Finance, you will develop and effectively manage annual budget for clinical activities
- PhD degree in health science field, PharmD, MD (non-US MD acceptable), or other relevant advanced degree in a health science field.
- The candidate should have a minimum of 5 years of clinical research experience in oncology clinical trials. Kinase inhibitor and/or pediatric drug development experience highly desirable.
- Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
- Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward
- Excellent written and oral communication and presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical
- Experience operating effectively within a matrixed environment, specifically in a healthcare biotech/pharmaceutical start-up setting
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
- Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.