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Principal Scientist, Clinical Pharmacologist/Modeling and Simulation

South San Francisco, CA
Lycia Therapeutics, Inc. is a biotechnology company leveraging its lysosomal targeting chimera (LYTAC) platform from Founder and Chemistry Nobel Laureate 2022, Carolyn Bertozzi, to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins. Lycia’s next generation degraders harness the cell’s endogenous lysosomal trafficking and degradation machinery with the potential to degrade targets previously considered to be intractable, across a spectrum of indications. After raising $105 million in capital in 2021, Lycia is advancing an internal pipeline of novel degraders and has entered a strategic collaboration with Eli Lilly to address key unmet medical needs. In May 2024, Lycia Therapeutics completed a $106.6 million series C financing to advance its pipeline of LYTAC extracellular protein degraders to the clinic. Lycia is headquartered in South San Francisco. 

Visit https://lyciatx.com/ for more information.

The Role:

Lycia Therapeutics is seeking a team-oriented Principal Scientist with a strong pharmacokinetics background to help develop novel small molecule and protein-based therapeutics. As a Pharmacokinetics/Clinical Pharmacology Principal Scientist, you will utilize your experience to further characterize the novel kinetics of our new therapeutic modality and build complex models that inform study designs and decision-making throughout the drug development process. At Lycia, you will be instrumental in shaping the development trajectory of our innovative therapeutic candidates and bringing transformative therapies to patients in need.

Key Responsibilities:

  • Perform pharmacokinetic data analysis, including non-compartmental and compartmental analyses, to derive relevant pharmacokinetic parameters. Analyses to be performed initially on data from nonclinical studies and subsequently from first-in-human clinical trials. Present results to interdisciplinary teams, contributing to project decisions and fostering a collaborative and transparent environment.
  • Drive the application of quantitative pharmacokinetic-pharmacodynamic (PK-PD) modeling to guide LYTAC dose selection, dose regimen optimization, and exposure-response relationships in non-clinical studies to aid in the selection of starting doses and dose regimen for first-in-human clinical trials. Iterative modification of PK-PD models as human data emerges.
  • Author regulatory submissions and serve as a pharmacokinetics/clinical pharmacology subject matter expert during interactions with regulatory agencies.
  • Collaborate closely with research and development teams to define project objectives and design innovative and scientifically rigorous pharmacokinetic studies that address the overall project goals.
  • Represent the clinical pharmacology function and provide subject matter expertise on cross-functional clinical study teams and at study dose level review meetings.
  • Contribute to the development of bioanalytical assays to quantify LYTAC concentrations and metabolites in various biological matrices.

Requirements:

  • PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field with at least 7-8 years of pharmacokinetics or PK/PD modeling experience within a pharmaceutical, biotechnology, or research setting.
  • Proven track record of designing, executing, and analyzing pharmacokinetic studies, integrating pharmacology and pharmacokinetics data to generate quantitative models, and experience developing analytical assays. Candidate with prior clinical pharmacology experience is preferred.
  • Strong proficiency in pharmacokinetic software (e.g., WinNonlin, NONMEM) and relevant modeling tools.
  • Ability to adhere to tight timelines across multiple research projects and adapt to changing priorities.
  • Highly motivated and organized team player with excellent written and oral communication skills and the ability to contribute to multiple projects simultaneously.
  • Creative problem solver with the desire and technical skills required to develop the novel approaches needed to characterize the pharmacokinetic profile for a new class of therapeutic proteins.
  • Prior experience authoring sections of INDs, clinical protocols, Investigator Brochures, and Clinical Study Reports pertaining to Clinical Pharmacology or nonclinical pharmacokinetic studies or data.

$180,000 - $210,000 a year
The expected base salary range for this role is $180,000-$210,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status

 

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