Director, Clinical Pharmacology
Day One Biopharmaceuticals
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Sterling, VA, USA · Remote
Posted on Aug 20, 2024
DIRECTOR, 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 serve as the subject matter expert (SME) and clinical pharmacology (Clin Pharm) lead of Day One’s antibody-drug conjugate (ADC) program. The incumbent will be tasked to expand the internal team’s expertise on ADC and play a critical role in dose optimization from both scientific (i.e., mechanisms of actions [MoAs]) and clinical perspectives (i.e., standard of care and unmet medical needs).
The 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 Vice President, Head of Clinical Pharmacology. The incumbent may serve as a senior leader of the Clin Pharm team and provide guidance to other team members.
This position has the potential to be fully remote. Occasional travel will be required for in-person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Serve as the Clin Pharm lead of the ADC program at the cross-functional team:
o Develop in-depth understanding of ADC’s PK/PD characteristics, MoAs, and unmet medical needs of potential indications
o Play a critical role in dose optimization and indication selection in support of early clinical development
o Translate cross-functional team’s questions to specific Clin Pharm questions with well-defined scope of work and clear timelines to execute
o Author and execute Clin Pharm Development Plans in a timely manner
o Author/co-author and review documents such as clinical trial protocols, clinical study reports and regulatory submission packages
o Support Medical Affairs on Day One posters at medical conferences; prepare abstracts and manuscripts for publication
o Address Clin Pharm related questions from medical monitors, investigators, and other cross functional team members
o Lead the Clin Pharm support for discussion and negotiation with Health Authorities
· Serve as a strategic leader of the ADC program:
o Identify issues impacting the programs and lead issue resolution
o Influence development programs based on scientific, clinical, and business insights
o Manage junior colleagues/ contractors including development, mentoring, and effective delegation
· If necessary, provide Clin Pharm support to other Day One asset(s)
· If 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
QUALIFICATIONS
· PhD, PharmD or equivalent training in Pharmaceutical Sciences
· Typically 10 years of Clin Pharm experience in the industry
· Extensive experience with clinical-stage ADC programs
· Strong communication and interpersonal skills
· Passion to establish himself/herself as an ADC expert in the scientific community
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 $220,000 - $240,000. 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.
This job is no longer accepting applications
See open jobs at Day One Biopharmaceuticals.See open jobs similar to "Director, Clinical Pharmacology" Canaan Partners.