Senior Director, Clinical Pharmacology

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 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.
• 12+ years of industry experience in clinical pharmacology, with a strong track record in early-phase and clinical development.
• Experience with rare disease and/or orphan drug development programs, combination therapy development, obesity, metabolic, endocrinology, or neuroendocrine therapeutic areas, and pediatric development and extrapolation strategies preferred.
• In-depth knowledge of regulatory requirements, ICH guidelines, and global health authority expectations for clinical pharmacology including formal meeting preparation and dossier authorship.
• Demonstrated experience supporting global regulatory submissions and participating in formal health authority interactions (FDA, EMA, PMDA, and/or other regulatory agencies).
• Proven ability to lead cross-functional teams and represent the function in strategic discussions and regulatory meetings.
• Familiarity with population PK/PD modeling and simulation tools desirable (e.g. NONMEM, Phoenix WinNonlin, R, Simcyp).
• Experience partnering with nonclinical DMPK/ADME functions and applying translational principles to support clinical development strategy preferred.
• Experience in obesity/metabolic/neuroendocrine therapeutic areas preferred.
• Proven ability to learn new information rapidly and effectively while working in a highly dynamic and fast-paced environment.
• Strong leadership, communication, and cross-functional collaboration skills.
• Excellent verbal and written communication with the ability to influence across the organization.
• Creative, innovative, strategic, problem-solving approach.
• Independent self-starter, but with an ability to be a strong team player in a highly collaborative environment.