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Associate Director, DMPK

Day One Biopharmaceuticals

Day One Biopharmaceuticals

Sterling, VA, USA · Remote
Posted on Thursday, July 11, 2024
ASSOCIATE DIRECTOR, DMPK
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically 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:
Day One Biopharmaceuticals is seeking an exceptional individual and scientist to join our Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalysis group. The successful candidate will support the DMPK, ADME and regulated bioanalysis activities across research and clinical stage drug development programs, including interactions with CROs and internal project stakeholders. This individual will be responsible for represent their function on study and project teams and may participate in regulatory interactions. This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Implement and manage bioanalysis of plasma and biological matrices to support pharmacokinetic, toxicokinetics and regulated bioanalysis for nonclinical and clinical programs.
· Work effectively with bioanalytical CROs for method transfer, method development and validation activities, and review regulated bioanalytical reports across nonclinical and clinical development programs.
· Conduct routine ADME and PK studies to support nonclinical and clinical development programs
· Author and review ADME study reports.
· Author and review TK reports from toxicology studies.
· Support authoring and review of relevant sections in regulatory documents, including protocols and IBs.
· Organize and manage research data.
· Provide input into PK/PD and study design aspect to support in vivo pharmacology studies.
· Participate in due diligence and business development activities as needed.
· Stay current with the latest advancements in bioanalysis and DMPK related regulatory guidelines.
· Work cross-functionally with the R&D organization.
· Present data at project team meetings.
QUALIFICATIONS
· Ph.D. in Pharmaceuticals Sciences, Pharmacokinetics, Drug Metabolism or a related field with 8+ years of industrial experiences in drug discovery and development; or a MS in related field with 15+ years of industrial experience.
· Verifiable track record of drug development experiences in advancing programs through different stages of drug development.
· Thorough knowledge of FDA and ICH guidelines.
· Proven experience in designing, conducting and interpreting in vitro and in vivo DMPK studies supporting candidate development.
· Strong knowledge of regulated bioanalytical principles and current guidance. Familiarity with both LC-MS/MS and ligand binding assay (LBA) method development is a plus.
· Experience in coordination of in vitro biotransformation, enzyme and transporter-mediated DDI studies.
· Meticulous attention to detail.
· Familiar with Phoenix WinNonlin, Excel and Prism software.
· Excellent interpersonal, oral and written communication skills in a highly collaborative work environment.
· Capable of working autonomously and collaboratively in a multi-disciplinary team setting.
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 $185,000 - $195,000. 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.