Associate Director, Clinical Scientist

 
ASSOCIATE DIRECTOR, CLINICAL SCIENTIST
 
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. For more information, please visit our website at http://www.dayonebio.com.
                                                                                                    
 
POSITION SUMMARY: 
 
The Associate Director, Clinical Scientist 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 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, Clinical Scientist will work closely with the Medical Director and VP of Clinical Development to ensure the integrity and success of Day One's clinical trials. Open, effective, and proactive communication, reliability and follow through of the clinical development activities are 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 desirable.
 
This position has the potential to be fully remote. Must be willing to travel 10 – 15% of time for in person meetings and conferences.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
 
·       Contribute to the design, implementation (study start-up, execution, analysis), review, and communication of clinical protocols and study reports for scientific and operational accuracy
·       In collaboration with Clinical Operations and Data Management responsible for analyzing data and timely delivery of high-quality clinical study data analysis for publications and scientific presentations; present clinical study results to the cross functional team and external stakeholders
·       Work with the Medical Director to review clinical data and develop clinical development strategy with KOLs
·       Collaborate with the Medical Director and Clinical Operations to expedite execution of clinical trials
·       Interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge and 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 to develop robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment
·       Responsible for writing, reviewing, and/or approving clinical project deliverables such as investigational product labeling/kitting, Pharmacy Manuals, informed consent, regulatory submissions/approvals, site activation materials, monitoring plan and tools, CRF's, DMP, edit checks, safety plans, close-out plans, CSRs and SOPs
·       Assist with the development of study presentations, handouts, and coordination of Investigator Meetings
·       In cooperation with Clinical Operations and Finance, develop and effectively manage annual budget for clinical activities
 
QUALIFICATIONS and SKILLS
 
·       Masters/PhD degree in health science field, PharmD, MD (non-US MD acceptable), MSN, 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, including a minimum of 8-10 years industry experience. Experience with kinase inhibitors and/or pediatric drug development experience highly desirable.
·       Excellent time management skills including reliability and using discernment to prioritize and complete tasks, meet deadlines, and be flexible to changing priorities
·       Sincerity and a caring attitude toward others
·       Possess a growth mindset and interest in continuous learning
·       Desire to make an impact in the lives of patients with cancer
·       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 clinical trials forward, in collaboration with the Medical Monitor
·       Excellent written and oral communication skills with team members and externally facing stakeholders
·       Excellent presentation skills
·       The ability to manage multiple priorities, while maintaining attention to detail, is critical
·       Experience operating effectively within a matrixed work from home environment, specifically in a healthcare biotech/pharmaceutical start-up setting
·       Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels
·       Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient.
·       Must have strong work ethic and be able to work independently and productively.
·       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.
 
 
DISCLAIMER
 
Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
 
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.
 
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.