SENIOR MANAGER, CLINICAL PHARMACOLOGY
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 successful candidate will act as the Clinical Pharmacology (Clin Pharm) lead for tovorafenib postmarketing requirement and commitment (PMR/PMC) drug-drug interaction (DDI) studies. In addition, this person may provide Clinical Pharmacology support to other clinical trials of tovorafenib or other Day One asset(s).
This position requires an individual with work experience and demonstrated leadership in a matrix environment as this person is expected to proactively plan for milestones, identify key stakeholders, facilitate cross-functional team alignment, and drive the progress with risk mitigation strategies. This position reports to Associate Director, Clinical Pharmacology.
This position has the potential to be fully remote. Occasional travel will be required for in-person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Represent Clin Pharm function at the cross-functional team and accountable for milestone deliverables of Clin Pharm PMR/PMC studies
o Build strong work relationships with key stakeholders (Clinical Development, Pharmacovigilance and Patient Safety, CMC, Regulatory, Clinical Operations, Biometrics and DMPK)
o Ensure timeliness and quality of deliverables per agreement with FDA
o Scientific responsibility for the design, execution, analysis, interpretation and reporting of Clin Pharm studies of tovorafenib
o Author/co-author and review documents such as clinical trial protocols, clinical study reports and regulatory submission packages
o Lead the Clin Pharm support for discussion and negotiation with regulatory agencies
Provide Clin Pharm support to other tovorafenib studies or other Day One asset(s)
o Anticipate the requests from the cross-functional team
o Translate cross-functional team’s questions to specific Clin Pharm questions with well-defined scope of work and clear timelines for external vendors to execute
o Address Clin Pharm related questions from medical monitors and investigators
o Support medical affairs on Day One posters at medical conferences; prepare abstracts and manuscript for publication
o Influence development programs using model-informed quantitative approaches (e.g., exposure-response analysis) to evaluate risk/benefit and facilitate drug development decisions
When necessary, independently conduct preliminary PK analyses (i.e., NCA) using Phoenix WinNonlin and present the results with summary statistics and figures.
- Oversee external vendor(s)
o Ensure the performance of external vendors meet the team’s expectation
o Provide feedback to the vendor(s) in a timely manner
o Proactively plan for risk mitigation strategies if necessary
QUALIFICATIONS
- PhD in Pharmaceutical Sciences or PharmD
- Experience of leading at least one (1) clinical DDI study
- Experience of drafting Clin Pharm responses to support regulatory interactions
- Proficient in using Phoenix WinNonlin
- Prior experience of working at a pediatric hospital is not required but highly desirable
- Typically 3+ years of related work experience is highly desirable
- The ideal candidate will be an excellent communicator with strong interpersonal skills and passion to grow their career in the pharmaceutical industry
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 $170,000 - $180,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
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 a sincerely held religious belief.
We are unable to sponsor or take over sponsorship of any applicant work visas at this time.
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.