Draig Therapeutics · 4 weeks ago
Director, Development DMPK
Greater Boston
Full-time
Onsite
Director/Executive
10+ years expDraig Therapeutics is a rapidly growing clinical-stage biotech focused on pioneering innovative therapies for depression and neurological disorders. The Director of Development DMPK will lead the DMPK strategy, ensuring robust data packages for drug development and collaborating across various teams to influence clinical protocols and decision-making.
BiopharmaBiotechnologyClinical TrialsTherapeutics
Responsibilities
Define and deliver DMPK strategy across all programmes, ensuring alignment with nonclinical, clinical, and regulatory development plans
Provide scientific leadership in the design, conduct, and interpretation of nonclinical and clinical ADME/PK, bioanalysis, metabolite profiling, drug–drug interaction, and PK/PD modelling and simulation studies
Apply world-class science to drive a translational understanding of drug disposition and PK/PD, supporting decision-making from candidate selection through clinical proof-of-concept
Champion model-informed drug development (MIDD) and ensure application of modern ADME and PK modelling principles to guide dose selection and de-risk development
Drive best-practice sharing across internal and external teams to ensure scientific excellence and consistency
Manage multiple CROs and specialist consultants conducting in vitro and in vivo ADME/PK, bioanalytical, and TK studies
Oversee study design, execution, data quality, and reporting, ensuring compliance with global regulatory standards (FDA, EMA, MHRA, ICH)
Efficiently manage outsourcing budgets, timelines, and capacity to deliver high-quality data packages across several parallel projects
Proactively identify study issues, coordinate resolution with CROs, and ensure delivery of accurate, submission-ready reports
Maintain oversight of bioanalytical strategies and ensure appropriate validation and GLP compliance where required
Partner with Nonclinical Safety to interpret exposure and metabolism data, supporting toxicological and safety de-risking strategies
Collaborate closely with Clinical Development, CMC, and Regulatory Affairs to integrate DMPK insights into clinical protocols, dose selection, and development strategy
Provide high-quality DMPK input into protocols, Investigator’s Brochures, regulatory submissions (INDs, CTAs), and responses to agency queries
Represent DMPK within internal governance forums and at meetings with external stakeholders and regulators, as required
Keep abreast of advances in ADME science, modelling tools, and regulatory guidance, applying these to improve Draig’s approaches
Engage with the wider DMPK scientific community and key opinion leaders to stay current on emerging methodologies
Contribute to developing internal DMPK capability through mentoring, training, and establishing best practices as Draig’s pipeline and team expand
Provide clear, concise communication of DMPK findings and their implications to senior leadership and multidisciplinary teams
Qualification
Required
PhD (or equivalent) in Pharmacology, Biochemistry, Pharmaceutical Sciences, or a related discipline
10+ years' established experience in DMPK/ADME within biotech or pharmaceutical drug development, spanning discovery through early clinical phases
Strong expertise in bioanalysis, PK/PD modelling, and interpretation of both nonclinical and clinical ADME data
Proven ability to design and oversee complex outsourced DMPK programmes, including vendor management, budget oversight, and quality control
Deep understanding of PK, PK/PD, ADME, metabolism, drug–drug interactions, and modelling approaches to support drug development decisions
Demonstrated success contributing to regulatory submissions and supporting health authority interactions
Skilled in proactive issue identification, troubleshooting, and resolution under evolving priorities
Excellent verbal, written, and interpersonal communication skills, with the ability to influence and collaborate across multidisciplinary teams
Preferred
Experience in CNS drug development and blood–brain barrier penetration considerations
Proficiency in PK/PD modelling and simulation platforms (e.g., Phoenix, GastroPlus, Simcyp)
Experience with clinical pharmacokinetics and clinical ADME data across early and mid-stage trials
Experience building or scaling DMPK capabilities within a fast-growing biotech organisation
Company
Draig Therapeutics
Draig Therapeutics is a clinical-stage biopharmaceutical startup.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$140MKey Investors
Access Biotechnology
2025-06-18Series A· $140M
2024-09-01Seed
Leadership Team
Ivana Magovčević-Liebisch
President and CEO
Inderjit Kaul
Chief Medical Officer
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