Director, Clinical Pharmacology
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Erascais a clinical-stage precision oncology company focused on discovering developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancersmost commonly mutated signaling cascades the RAS/MAPK pathway which affects approximately 5.5 million lives each year worldwide. The name Erasca has an important embedded meaning: it is a contraction of our audacious hope to erase cancer that drives our mission and everything that we do on behalf of patients with cancer.
PositionSummary:
The Clinical Pharmacology Lead is responsible for providing clinical pharmacology expertise to the cross functional product development team and contributing to clinical development through advancing MIDD (Model Informed Drug Development) initiatives. The core job responsibilities include analysis interpretation and reporting of clinical PK and PK/PD data preparation and review clinical pharmacology data for regulatory submissions. This position also covers the DMPK Lead role through collaboration with research team on non-clinical DMPK and translational pharmacology activities.
Essential Duties and Responsibilities:
- Provide clinical pharmacology expertise to the cross functional product development team.
- Conduct data analyses including non-compartmental PK analyses pop PK and ER analyses.
- Design and execute clinical pharmacology studies (eg food effect DDI AME/Mass Balance studies).
- Co-author regulatory documents such as protocol study report healthy authority briefing book and IB.
- Collaborate with research team on non-clinical DMPK and translational pharmacology activities.
- Manage external CROs to ensure compliance with planned study protocols deliverables internal quality control standards and timelines.
- Perform all duties in keeping with the Companys core values policies and all applicable regulations.
Required Education and Experience:
- PhD or PharmD with training in relevant fields such as pharmaceutical sciences clinical pharmacology or engineering with a minimum of 6 years of relevant working experience (for the Director level position).
- Solid knowledge and experience in pharmacokinetics pharmacodynamics and drug metabolism.
- Proficient in using WinNonlin NONMEM R and other modeling and simulation software.
- Working experience in preclinical and clinical development of investigational drugs in diverse platforms including small molecules and biologics.
- Proven track record in authoring DMPK and Clinical Pharmacology components of regulatory documents.
- Excellent collaboration communication and interpersonal skills.
- Must be a highly flexible results oriented independent self-starter who enjoys working in a fast-paced and dynamic team-oriented environment.
The anticipated salary range for this position is $205000 to $315000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry education etcetera. In addition to base salary the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
Along with our casual collaborative and fun work and the chance to make your mark in our mission to erase cancer Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off Holiday and Sick Leave Medical Dental and Vision Plans Short- and Long-Term Disability Basic and Voluntary Life/AD&D Coverage Flexible Spending Accounts (FSA HSA and Commute) Critical Illness and Accident Coverage Pet Insurance Employee Assistance Program 401(k) Plan with Erasca contribution and the opportunity to participate in an Employee Stock Purchase Program.
Erasca Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of sex race religion national origin ancestry physical or mental disability protected medical condition genetic information marital status registered domestic partner status age sexual orientation military and veteran status or any other basis protected by federal state or local law or ordinance or regulation.
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Coaching
- Analysis Skills
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Mentoring
- Public Speaking
- negotiation
- Supervising Experience
About Company
Erasca is a clinical-stage precision oncology company driven by a bold mission—to erase cancer. We are on a journey to shut down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. Our promi ... View more
