Senior Director, Clinical Pharmacology

rhythmpharmaceuticals; Boston (MA); Hybrid; USD 210.000 - 300.000; Vollzeit

Benefits dieser Stelle

Discretionary bonus

Restricted stock units

Hybrid work model

Zusammenfassung

Rhythm Pharmaceuticals seeks a Senior Director of Clinical Pharmacology to lead early and late-phase pharmacology strategies for rare neuroendocrine diseases. Reporting to the CMO, you will shape development plans, design and interpret pharmacology studies, and guide regulatory interactions across global programs.

You will collaborate with clinical operations, regulatory, biostatistics, and translational sciences to align pharmacology plans with portfolio goals, oversee CROs, and drive

Qualifikationen

• Ph.D., Pharm.D. or equivalent doctoral degree in Clinical Pharmacology or related field.
• 12+ years in clinical pharmacology with early and late-phase development experience.
• Experience with rare disease/orphan drug programs and pediatric extrapolation.
• Regulatory submissions experience and interactions with health authorities (FDA/EMA/PMDA).
• Leadership of cross-functional teams and collaboration with clinical, regulatory, and non-clinical groups.

Aufgaben

• Define and lead the clinical pharmacology strategy for programs across phases.
• Oversee pharmacology studies for dose selection, exposure-response, and DDI.
• Develop model-informed drug development (MIDD) approaches.
• Prepare regulatory documents and interact with health authorities.
• Manage CROs/vendors and ensure high-quality pharmacology outputs.

Kenntnisse

Strategic leadership

Cross-functional collaboration

Regulatory strategy

Clinical pharmacology

Orphan/rare disease experience

Communication

Ausbildung

Ph.D., Pharm.D. or equivalent

Tools

NONMEM

Phoenix WinNonlin

R

Simcyp

Jobbeschreibung

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.
• 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.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

The expected salary range for this position is $210,000 - $300,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

More about Rhythm

We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.

Our team is passionate aboutexpanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success
• We value the unique contribution each individual brings to furthering our mission

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.