Senior Director, Clinical Pharmacology

Rhythm Pharmaceuticals Inc.; Boston (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Rhythm Pharmaceuticals Inc. is seeking a Senior Director, Clinical Pharmacology to lead strategy across early and late-phase programs for small molecule and peptide therapies in rare neuroendocrine diseases.

You will partner with senior leadership to influence development strategy, regulatory planning, and portfolio decisions while overseeing pharmacology studies and vendor relationships. The role requires therapeutic leadership, global regulatory experience, and ability to guide dose selection,

Qualifications

• Ph.D., Pharm.D., or equivalent doctoral degree in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline.

Responsibilities

• Lead the clinical pharmacology strategy for early and late-phase development programs, including mono- and combination-therapy approaches.
• Design, execute, and interpret clinical pharmacology studies across the development lifecycle (Ph1–Ph3), including PK/PD and dose selection.
• Develop and oversee model-informed drug development (MIDD) strategies to optimize dose selection and regimen design.
• Collaborate with cross-functional teams to align pharmacology plans with development objectives.
• Author and review regulatory docs (INDs, CTAs, NDAs/MAAs) and represent pharmacology in regulatory interactions.

Skills

Clinical Pharmacology

Education

Ph.D., Pharm.D., or equivalent

Job description

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview

Rhythm Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology with demonstrable experience and expertise in early and late-phase clinical development of small molecule and peptide mono- and combination-therapy strategies to join our development team. The successful candidate will report to the CMO and play a critical leadership role in shaping and executing the clinical pharmacology strategy for programs targeting rare neuroendocrine diseases. This individual will serve as the company’s clinical pharmacology subject matter expert, partnering closely with senior leadership to influence portfolio decisions, development strategy, and regulatory planning across the pipeline. The successful candidate will combine strategic leadership with hands‑on scientific and operational execution and will help shape how the clinical pharmacology function grows at Rhythm. Responsibilities will include the design, implementation, and interpretation of clinical pharmacology studies to support dose selection, exposure-response characterization, and combination regimen development. This individual will work cross-functionally with clinical development, regulatory affairs, biostatistics, translational sciences, and non‑clinical teams to ensure integrated development plans. The role will also lead the preparation of regulatory submissions, oversee specialty vendors/CROs, and represent the company in interactions with global health authorities.

Responsibilities And Duties

• Lead and define the clinical pharmacology strategy for early and late-phase development programs, including mono- and combination-therapy approaches.
• Support and interface with DMPK workstreams to inform nonclinical study designs, translational PK/PD predictions, and interpretation.
• Design, execute, and interpret clinical pharmacology studies across the development lifecycle, including but not limited to:
  • Ph 1: first-in-human, SAD/MAD, and drug-drug interaction studies, food effect
  • Ph 2: PK/PD and dose selection and optimization strategy.
  • Ph 3 and beyond: Exposure response analyses supporting Ph 3 and registration, pediatric extrapolation, and dosing justification.
• Develop and oversee model-informed drug development (MIDD) strategies to optimize dose selection and regimen design.
• Collaborate closely with internal stakeholders across clinical operations, regulatory, biostatistics, and non‑clinical functions to ensure alignment of pharmacology plans with overall development objectives.
• Author and review clinical pharmacology components of global regulatory documents (e.g., INDs, CTAs, IBs, briefing packages, NDAs/MAAs) and represent clinical pharmacology in regulatory agency interactions (FDA, EMA, PMDA etc.).
• Lead clinical pharmacology strategy supporting global registration, label optimization, lifecycle management activities, and post‑marketing regulatory commitments.
• Provide scientific leadership in evaluating pharmacokinetic and pharmacodynamic data to inform clinical decision‑making.
• Represent Rhythm at scientific congresses, advisory boards, investigator meetings, and interactions with external experts and key opinion leaders.
• Serve as a strategic advisor to the CMO and Clinical Leadership Team on clinical pharmacology, translational medicine, dose optimization, regulatory strategy, and portfolio decision making.
• Direct and oversee specialty CROs, external pharmacometrics consultants, and bioanalytical vendors to ensure high quality and compliance.
• Help establish functional infrastructure, external partnerships, standard operating procedures, and best practices to support the continued growth and evolution of clinical pharmacology capabilities at Rhythm.

Qualifications And Skills

• Ph.D., Pharm.D., or equivalent doctoral degree in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline.