DIRECTOR, MEDICAL DIRECTOR
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:
This is an exciting opportunity in a fast-paced, growing, mission-driven biotech company rapidly moving towards commercialization. We are seeking an experienced, motivated, and outgoing physician/physician-scientist to join us as Director, Medical Director. Reporting to our Global Clinical Lead for DAY101, the Director, Medical Director will be accountable for providing medical and scientific expertise and oversight for clinical trials, and will serve as the single point of accountability for the design, execution, monitoring, delivery, and reporting of one or more early and/or late-stage clinical studies.
Additional study level activities include acting as medical monitor for clinical trials, accountability for patient safety, and providing medical guidance during the design, execution, and reporting for clinical studies. The Director of Clinical Development will also be responsible for presentation of study results to internal and external committees or advisory boards, as well as preparation of data for presentation at international scientific meetings and publication.
In addition to study level activities, the Medical Monitor will participate in program level
activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator
brochures, risk management plans, periodic safety updates and clinical sections of product labels. This position is subject to travel 25% for in person meetings and major conferences.
The Director, Medical Director will be a partner to the DAY101 Global Clinical Lead, and will apply their knowledge, experience, and skills to the ongoing development of our lead product, DAY101. ESSENTIAL DUTIES AND RESPONSIBILITIES:
The areas of specific responsibility and attention will include, but are not limited to, the following:
· Clinical Trial Strategy and Design
o In collaboration with the broader study and project team(s), design of clinical studies to meet the stated objectives
o Be accountable for the review and amendment of clinical trial protocols
o Review and approve informed consents
o Provide medical input into the assessment of investigational site capabilities
o Participate in the review and approval process for data capture and review
o Organize expert panels, consultants, or advisor board meetings to provide input into protocol development and data analysis.
· Provide Study Team with Medical Expertise
o Protocol training for investigators
o Issue resolution
o Audit responses
o Study conduct and closeout
o Inspection readiness
· Provide accountability for safety across studies
o Ensure development of and/or adherence to safety review plans
o Perform and document regular review of individual subject safety data, and review of cumulative safety data
o Working with our Drug Safety team, review individual subject data (including AEs and other safety data), SAEs, and potentially clinically important findings, as well as determine whether or not follow-up is needed
· Study Level Data Review
o Working with our clinical scientists and biometrics colleagues, perform reviews of data generated by statistical analyses, requesting additional tables or analyses as needed
o Perform reviews and procedures required for database finalization
o Lead the authoring of clinical study reports
o Lead the authoring of clinical sections of regulatory documents (e.g. IB, IND annual reports, etc.)
· Answer and Resolve Medical and Safety Questions from Sites
o General protocol questions, questions on inclusion/exclusion, safety management, etc.
o Ensure answers are consistent across study regions
· Interact with Regulatory Authorities and Internal Regulatory and QA Groups on a Study Level
o Support regulatory interactions, accountable for providing responses to regulatory inspection observations, internal audits, etc.
o Support RA updates and submissions for IND documents (IB, DSUR, protocol, etc.)
o Assist with clinical sections of regulatory filings
· Presentations and Publication of Clinical Trial Results
o Assist in the preparation and delivery of clinical study reports and results for internal (corporate) and external (regulatory) purposes, as well as external medical and scientific conferences and meetings QUALIFICATIONS
The Director, Medical Director must be a natural leader with expertise in oncology clinical research. This individual will have proven experience in leading and collaborating with teams and individuals across various functions in a fast-paced, global environment. Experience in drug development for pediatric oncology and/or rare diseases would be preferred but not required. A solid understanding of early- and late-stage drug development and clinical research conducted under GCP/ICH is essential.
More specifically, it is anticipated that the ideal candidate will possess:
· An MD or MD/PhD degree is required
· 2-5 years of experience in the biopharmaceutical industry with experience in oncology drug development and design/conduct of clinical trials
· Training and experience in oncology; pediatric oncology and/or neuro-oncology experience is preferred but not essential; board certified or eligible in oncology (and/or hematology)
· Knowledge of ICH and Good Clinical Practice and familiarity with global and regional regulations as well as pediatric-specific regulations (e.g. EMA PIP and FDA iPSP processes)
· Experience in the assessment of adverse events and safety of patients participating in oncology clinical trials
· Skilled in modern oncology protocol design, data interpretation, biostatistics, and medical monitoring
· Strong interpersonal skills, as well as the ability to function in a team environment
· Ability to lead by example, build interdependent partnerships, and participate in a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility
· Able to prioritize and manage several projects simultaneously
· Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
· Proven ability to develop internal relationships in a matrix environment, whether in person or remotely, as well as external relationships with Key Opinion Leaders and industry experts
· Outstanding verbal, written, and presentation skills to enable effective communication at all levels that allows for the presentation of complex and/or new ideas with clarity and simplicity
· A desire to be part of a highly innovative company aimed at transforming the lives of children and adults with serious, life-threatening diseases, their families and society
· Exceptionally organized with keen attention to detail with the ability to shift focus and priorities when necessary, under pressure and within deadlines.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. COMPENSATION AND BENEFITS
The salary range for this position is $225,000 - $270,000. Day One Bio considers a range of factors when determining base compensation. These considerations mean actual compensation will vary. Click here
to see our competitive benefits.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.