Position Summary
We are seeking a Senior Director of Clinical Pharmacology to provide strategic and scientific leadership in clinical pharmacology. In this high-impact role, you will drive the development of clinical pharmacology plans, lead PK and PK/PD analyses, and play a key role in advancing our portfolio of peptide-based therapies across all phases of clinical development. Reporting into our Chief Medical Officer, you will play a vital role in shaping the clinical pharmacology approach at MBX Biosciences. Additionally, this position will inspire a high-performing team and promote an innovative, collaborative culture throughout the organization.
Key Responsibilities
- Serve as the primary clinical pharmacology lead for all programs and effectively participate in cross functional teams to ensure integration of modern clinical pharmacology principles into project plans and study design
- Develop and advise on PK and PK/PD study designs to optimize data collection and inform dose recommendations across all clinical phases.
- Craft analysis plans, conduct advanced PK and PK/PD evaluations, and translate data into actionable insights that drive development decisions.
- Generate high-quality clinical PK/PD reports and contribute to key regulatory documents, including Investigator Brochures (IBs), Clinical Study Reports (CSRs), Briefing Packages, and CTD Modules.
- Partner with clinicians, biostatisticians, and data managers to ensure timely delivery of analysis specifications and other critical outputs.
- Manage relationships with and oversight of external clinical pharmacology vendors
- Present findings at scientific conferences, foster collaborations, and publish in peer-reviewed journals to showcase MBX’s contributions.
- Other responsibilities as assigned.
Education & Qualifications
- MS, PharmD, or PhD in PhD degree in clinical pharmacology, pharmacokinetics, pharmaceutical sciences, pharmacology, chemistry, biochemistry, or related field.
- 10+ years of experience designing and executing clinical development plans.
- Experience with Peptide/Protein is preferred
- Demonstrated excellence in preparing regulatory documents and engaging with regulatory agencies.
- Strong proficiency in PK/PD analyses and modeling across all clinical stages, from FIH to registrational studies.
- Proven ability to build strong relationships across internal teams and external stakeholders.
- Quick thinker with the ability to navigate scientific and strategic challenges effectively.
- Detail-oriented leader with strong organizational skills and a commitment to high-quality work.
- Commitment to MBX’s core values; transparency, integrity, diversity, teamwork, innovation, and scientific excellence.
Company Overview:
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.