Senior Director, Drug Metabolism and Pharmacokinetics (DMPK)
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.
Position Summary:
The Senior Director of DMPK will report to the VP, Head of DMPK. In this role you will implement and help develop DMPK & bioanalytical strategies and provide critical basic research and development support for products in research and in the clinic, including regulatory submissions and ongoing analysis of clinical-stage compounds. Additionally, you will provide guidance and scientific stewardship for preclinical and clinical candidates, providing PK and biomarker assay support for the entire pipeline. As Sionna grows you will help build and grow the DMPK function and expertise.
As a member of the DMPK team, you will work closely with multiple functions within Sionna Research and Development; therefore, you must be highly adept at building and managing relationships across various functions and communicating scientific information across a matrixed organization.
Responsibilities:
- Collaborate within project teams and across other functional groups including research/biology, medicinal chemistry, toxicology, CMC, clinical, clinical pharmacology, and regulatory.
- Support the design, execution, analysis, interpretation, and communication of research and clinical PK/PD and ADME studies relating to Sionna’s therapeutic platforms of small molecules for the treatment of cystic fibrosis, including writing and/or overseeing reports and components of regulatory submission documents and ensuring delivery according to timelines.
- Help develop and execute superior DMPK strategies aligned with platform, programs, and company goals to achieve successful development candidates.
- Collaborate with Research and Development colleagues and project leaders in establishing PK/ADME profiles during drug discovery to select superior candidates for development, including robust assessment of ADME properties, transporters, human PK and dose projections, PK/PD relationships and drug-drug interaction potential.
- Support the DMPK team in the design and execution of all bioanalytical and preclinical/clinical PK/ADME studies and interpretation of DMPK data, using either in-house resources or CROs.
- Guide the development and validation of bioanalytical methods for the in vivo assessment of drug candidates and metabolites, including support for clinical studies and collaborate with Development Operations to select clinical PK and metabolite vendors.
- Collaborate with clinical and clinical pharmacology to provide expert interpretation of human PK and metabolite results from clinical studies.
- Build and maintain strong relationships with CROs, consultants and other external partners to provide additional expert DMPK resources and capabilities.
- Represent DMPK on a variety of interdisciplinary teams and corporate governance forums and serve as a key translator and communicator of DMPK data and outcomes for internal and external stakeholders.
Qualifications:
- PhD in Pharmacokinetics, Drug Metabolism, or a related field is required.
- 10+ years of industry experience demonstrating significant expertise, in-depth knowledge of DMPK science related to preclinical and clinical development and proven leadership, with broad knowledge and experience across PK, PD, ADME and bioanalytics. This experience should come within a biotechnology and/or pharmaceutical environment and inside a complex research and development setting, including experience with global regulatory submissions.
- Experience with small molecules is preferred.
- Proficiency in the use of advanced DMPK modeling and simulation tools.
- A demonstrated track record in innovation and creativity, critical scientific thinking, and analysis, with a deep level of curiosity and understanding of new technologies and cutting-edge approaches to address DMPK issues.
- Possess a strong track record of independently authoring and providing guidance to team members on technical reports/summaries, suitable for inclusion in clinical and regulatory submission documents (e.g., IB, IND, NDA).
