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Open nowPosted 6 days ago

Principal Scientist, Clinical Pharmacology

AbCellera36 open roles

Pay
$1,500 a month
Where
California
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Your applicationOpen nowPrincipal Scientist, Clinical PharmacologyAbCellera · California

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The clock on this job

Early applications get read.

13.8% of postings close within 7 days. Measured by our own scanner across the market. AbCellera postings stay open a median of 32 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.8%7 days
  4. 22.3%14 days
  5. 37.8%30 days
  6. 59.0%60 days
This job: posted 6 days ago

AbCellera median: 32 days open

The posting

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We are seeking an experienced scientist with expertise in Clinical Pharmacology who can help shape how AbCellera's antibody-based therapies are dosed, studied and developed, from first-in-human through late-stage development. In this role, you will lead the clinical pharmacology strategy for therapeutic programs while working closely with members from our Pharmacokinetics, Biomarkers, Clinical Development, Biometrics and Regulatory Affairs teams. You will apply Model-Informed Drug Development (MIDD) approaches to optimize clinical trial designs, justify dose selections, inform development decisions and mitigate risks across both early and late-stage development, acting as the clinical pharmacology voice on cross-functional program teams and in interactions with health authorities. If you are a clinical pharmacologist who is excited to use modeling and data to guide novel antibody therapies toward patients, we’d love to hear from you.

How you might spend your days

  • Leading the clinical pharmacology strategy for assigned therapeutic programs, from first-in-human through Phase 2 and into late-stage planning
  • Applying model-informed drug development (MIDD) approaches to justify doses and dosing intervals, optimize study designs, and support go/no-go decisions
  • Recommending first-in-human starting doses and escalation schemes by integrating nonclinical PK/PD, toxicology, target engagement and translational biomarker data
  • Building integrated clinical pharmacology plans that address PK, PD, exposure-response, dose and regimen selection, immunogenicity, intrinsic and extrinsic factors, and formulation or route changes
  • Executing pharmacometric methodologies such as population PK/PD, PBPK, and QSP to understand exposure-response relationships and define quantitative criteria to support data-driven decisions
  • Designing and interpreting the clinical pharmacology components of trials, including dose escalation, bioavailability and absorption kinetics, target-mediated drug disposition, special populations, and bridging studies
  • Writing and reviewing the clinical pharmacology content of protocols, Investigator Brochures, clinical study reports, briefing documents, CTAs and INDs, and other documents supporting Regulatory interactions
  • Preparing for health authority meetings and drafting responses to clinical pharmacology questions
  • Managing CROs and modeling service providers to deliver high-quality analyses on time
  • Presenting results and recommendations to program teams and senior leadership
  • Helping shape the clinical pharmacology function at AbCellera, including its processes and standards

We’d love to hear from you if

  • You have a PhD or PharmD in Pharmacology, Pharmaceutical Sciences, Pharmacometrics or a related quantitative discipline, with 8+ years of clinical pharmacology experience in the biotech or pharmaceutical industry (or an MSc and 12+ years of clinical pharmacology experience)
  • You have led clinical pharmacology for therapeutic antibodies or other biologics, and understand concepts such as target-mediated drug disposition, immunogenicity, and drug absorption kinetics
  • You have extensive hands-on experience with population PK and PK/PD, exposure-response modeling, pharmacometrics tools (e.g., NONMEM, Monolix, R) and methodologies (e.g. PBPK, QSP), and can critically review modeling work done by others
  • You have contributed clinical pharmacology content to regulatory submissions and health authority interactions (FDA, EMA, Health Canada, or others)
  • You have managed CROs or external modeling service providers
  • You have experience with incorporating Modelling & Simulations outcomes into regulatory documents (Investigator Brochures, Briefing books, IND filings, etc.)
  • You thrive in a dynamic working environment, supporting and working with cross-functional teams
  • You have an ability to express complex ideas in understandable ways, and to communicate effectively with people from different fields
  • You have excellent documentation skills with impeccable attention to detail

What we offer

In addition to base salary, we offer equity, an annual bonus dependent on individual and company performance, and a 6% 401K contribution. You will have a USD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.

Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

To apply

Please submit your application through our website and refer to Job ID 23427 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

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