Director, Clinical Pharmacology and Pharmacokinetics

Disc Medicine; Watertown (MA); On-site; USD 247,000 - 297,000; Full time

Benefits offered by this job

Flexible work environment

Hybrid role

Job summary

Disc Medicine in Watertown, MA, offers a hybrid opportunity for a Clinical Pharmacology Lead to guide multiple programs. You will design, execute, analyze and interpret clinical pharmacology studies including first‑in‑human, DDI, biopharmaceutics and ADME, partnering with internal teams, CROs and vendors to ensure scientific rigor and budget adherence.

You will also represent clinical pharmacology in regulatory interactions, contributing to regulatory strategy and submissions while mentoring

Qualifications

• PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism.
• Experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation.
• Experience with regulatory guidance and IND/EA submissions is preferred.

Responsibilities

• Serve as a clinical pharmacology lead for multiple programs and collaborate with cross‑functional teams.
• Manage and execute clinical pharmacology deliverables with CROs and internal partners.
• Design, execute, analyze, interpret and report clinical pharmacology studies (FIH, DDI, biopharmaceutics, ADME).
• Develop and maintain relationships with clinical operations, development, toxicology, DMPK, biostatistics and regulatory teams.
• Represent clinical pharmacology in regulatory interactions and contribute to regulatory strategy.

Skills

Clinical pharmacology

PK/PD analysis

Population PK

Regulatory interactions

CRO management

Bioanalytical collaboration

WinNonlin/R/NONMEM

Education

PhD in clinical pharmacology or related

Tools

WinNonlin

R

NONMEM

Monolix

Job description

Join our team in a dynamic hybrid role, offering flexibility to work remotely or from our headquarters in Watertown, MA.

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW

Reporting to the Vice President of Clinical Pharmacology the Clinical Pharmacology Lead will provide strategic and scientific leadership across multiple programs at Disc Medicine, serving as the clinical pharmacology representative on cross‑functional development teams. This role will lead the design, execution, analysis, and interpretation of clinical pharmacology studies and deliverables, including first‑in‑human, drug‑drug interaction, biopharmaceutics, and ADME studies. The successful candidate will partner closely with internal teams, external vendors, and CROs while providing scientific and budgetary oversight of clinical pharmacology activities. The role will also represent Clinical Pharmacology in regulatory interactions and contribute to regulatory strategy and submissions.

RESPONSIBILITIES:

• Serve as a clinical pharmacology lead for multiple programs at Disc Medicine working directly with the multi‑disciplinary teams.
• Manage and execute clinical pharmacology deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner and provide oversight for work conducted by contract research organizations (CROs).
• Have scientific and budgetary responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology related studies including first‑in‑human, drug‑drug interaction, biopharmaceutics and ADME studies.
• Establish and develop strong relationships with key cross functional partner functions such as clinical operations, clinical development, nonclinical toxicology, DMPK, biostatistics, medical writing, and regulatory.
• Represent clinical pharmacology in program teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies.

REQUIREMENTS:

• Education: PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism
• More than 10 years of industry experience working as a clinical pharmacologist. The exact level and responsibilities will depend on the individual's experience and interpersonal skills.
• Experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation is required.
• A working knowledge and previous experience in either (1) drug metabolism and drug‑drug interactions or (2) biologics/large molecule development is required.
• Familiarity with clinical pharmacology regulatory guidance and related areas is required.
• Experience with regulatory agency interactions including written responses and IND packages is required. Experience with End of Phase 2 and NDA/MAA regulatory interactions is preferred.
• Prior experience working with CROs is a plus.
• Working experience with bioanalysis, data management, and statistical programming groups is preferred.
• Advanced training in WinNonlin, R, NONMEM, and/or Monolix is preferred. Hands‑on experience performing population PK/PD analyses is preferred.
• Broad familiarity with the drug development process is highly desired.
• Must excel at working in a highly collaborative matrix team environment.
• Good organizational, communication [both oral and written], and interpersonal skills are required.

The annual base salary range for this position is listed below. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and internal parity.

Salary Range

$247,000—$297,000 USD

Disc Medicine is an equal‑opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages.

The Company headquarters are in Watertown, MA, and we provide a flexible work environment.

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence.

Disc Medicine respects your privacy. For information about how Disc processes your personal data in the context of your candidacy, please see our Privacy Notice.