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. Interested candidates should submit their resume to be
considered for current and future opportunities.
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
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