Day One Biopharmaceuticals (51-200 Employees, 736% 2 Yr Employee Growth Rate)
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.
As Director, Clinical Pharmacology you will be a key contributor to tovorafenib NDA submission and review. In addition, you will lead the tovorafenib Clin Pharm support for both adult and pediatric indications by working closely with other key stakeholders on the cross-functional team. You will have the opportunity to grow your expertise in the pediatric oncology population. This position reports to Head of Clinical Pharmacology.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Contribute to tovorafenib NDA submission and interactions with FDA including but not limited to the following activities: prepare pre-meeting briefing packages; address comments and information requests from regulatory authorities; lead PMR/PMC negotiations and label discussions related to Clin Pharm
· Independently lead Clin Pharm support for supplemental NDA submission (e.g., label expansion) to FDA
· Act as Clinical Pharmacology lead on tovorafenib cross-functional teams and contribute to clinical development in both pediatric and adult populations oversee PK and PK/PD analysis to support team decisions on study design (e.g., starting dose, dose escalation and dose in special populations); support clinical lead/medical monitor to address questions from the site, investigators, IRB or regulatory agencies of various regions/countries; develop in-depth understanding of drug disposition and target engagement
· Plan, design, execute, and report tovorafenib PMR/PMC studies
· Author/co-author and review documents such as clinical trial protocols, clinical study reports, investigator’s brochures and regulatory submission packages
· Oversee external vendors and ensure high-quality results are delivered in a timely manner
· Ph.D., Pharm.D. or equivalent training in pharmaceutical sciences
· 7-10 years of experience in drug development, regulatory agency, or pharmacy practice
· Prior experience with oncology drug development, pediatric indications or clinical/retail pharmacy preferred but not required
· The ideal candidate will be an excellent communicator with strong interpersonal skills and the ability to influence without authority
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
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 do 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.