Senior Scientist, Drug Metabolism And Pharmacokinetics

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles - and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.

Own the Big Picture

Context is critical. Ground every decision and action in the entirety of what we are trying to achieve.

Go THRD

We hold ourselves to a higher standard. Work with urgency, purpose, and passion.

The Role

Reporting to the Senior Director, Drug Metabolism and Pharmacokinetics, the Senior Scientist, Drug Metabolism and Pharmacokinetics (DMPK) will support discovery by conducting studies contributing to candidate nomination and development stage programs in accordance with regulatory guidance. This is a great opportunity to participate in advancing the next wave of medicine to meaningfully improve the lives of patients suffering from severe allergic inflammation.

Responsibilities

• Support DMPK strategy to ensure delivery of high-quality data packages in support of target validation through to regulatory filings

• Apply scientific knowledge and experience to cover a breadth of areas including the design, execution, and analysis and interpretation of pre-clinical and clinical PK and PK/PD studies.

• Apply quantitative skills to support model-based drug development and address complex issues via modeling and simulation.

• Represent DMPK on discovery project teams and collaborate with chemistry colleagues on SAR assessment

• Effective cross-functional collaboration, especially with vitro/in vivo pharmacology and toxicology, in the optimization of drug leads and candidates

• Represent DMPK on development team including completing regulatory guidance defined studies and taking ownership of summary sections in regulatory documents (e.g., IND section 2.6.4)

• Collaborate across functions to help with dosing strategies in animal efficacy models and toxicokinetics in toxicology studies

• Monitor and provide bioanalytical support for nonclinical and clinical studies

• Manage CRO relationships and oversee function's contracted studies

• Facilitate cross-functional collaboration by establishing strong relationships across research and development

• Prepare high impact presentations for internal and external communication

• Author and review reports and regulatory documents

Required Qualifications

• Ph.D./M.S./B.S. in clinical pharmacology, pharmacokinetics and metabolism, pharmacometrics, chemical/biomedical engineering, computational biology/chemistry or a related field with 5/8/12+ years' pharmaceutical industry/academic experience.

• Experience with non-compartmental analysis and pharmacokinetic modeling (e.g., Phoenix WinNonLin)

• Demonstrates a sound knowledge of DMPK and PK/PD principles

The salary range for this role is $155,000-$175,000.

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.