Clinical Pharmacologist (Contract)

 
CLINICAL PHARMACOLOGIST (CONTRACT)
 
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 a great opportunity for an experienced pharmacist to transition to the pharmaceutical industry and leverage experience to develop new medicines for children with cancer and for people of all ages with life-threatening diseases.
 
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
 
·       Apply state-of-the art scientific principles and regulatory guidelines in the field of clinical pharmacology and pediatric drug development to advance the development of Day One assets.
·       As a member of clinical study team, author/coauthor and review study documents (Protocols, Investigator's Brochure and Clinical Study Reports)
- Provide input on PK sampling schedules, drug interaction risk assessment, and concomitant medications in close collaboration with DMPK and bioanalysis team.
- Work closely with Medical Monitor, Safety Physician, DMPK, Translational Sciences, Biometrics and other functions to ensure accurate interpretation of clinical data and the selection of the right dose for the right patients.
- Address ad-hoc questions from Medical Monitor, Investigators, and Regulatory Agencies
·       Lead the design and execution of dedicated clinical pharmacology studies (e.g., relative bioavailability, drug interaction) in healthy subjects and patients.
·       Independently conduct preliminary PK analyses (i.e., NCA) using Phoenix WinNonlin and present the results with summary statistics and figures.
·       Contribute to the oversight of the population PK, exposure-response and other quantitative analyses conducted by vendors.
·       Contribute to the discussion with Health Authorities in support of INDs and NDAs
·       Contribute to the publication of Clinical Pharmacology study results on peer-reviewed journals as the lead author or coauthors
 
QUALIFICATIONS
 
·       PhD, PharmD or equivalent training in Pharmaceutical Sciences.
·       5-10 years of experience in Regulatory Agency, Pharmaceutical Industry or Pharmacy.
·       Prior experience with oncology drug development, pediatric indications or hospital pharmacy preferred but not required.
·       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
 
The hourly range for this position is $65-$85/hour. Day One Bio considers a range of factors when determining compensation. These considerations mean actual compensation will vary.
 
 
DISCLAIMER
 
Day One 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.
 
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.