Director, Development DMPK

Title:
Director/Senior Director, Development DMPK

About Draig Therapeutics:

Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing - one of the largest ever in neuropsychiatric drug development. We are pioneering innovative small-molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders.

Why Join Draig?

At Draig Therapeutics, you'll join a science-first, mission-driven biotech that is redefining what a small, agile, and deeply collaborative organization can achieve. Backed by strong investors and propelled by a bold CNS discovery pipeline, Draig brings together world-class scientists, a caring culture, and the energy of a company on an incredible growth trajectory. Here, innovation and speed aren't just encouraged - they're expected. You'll partner closely across Discovery, Nonclinical, and Clinical Development, helping to shape programmes that have the potential to transform patient lives. This is an environment where your voice matters, your expertise has real impact, and your work directly influences how promising molecules move from concept into the clinic. At Draig, you won't just contribute to groundbreaking science - you'll help build a biotech with purpose, speed, and heart. For more info, please visit our website.

Responsibilities:

This is a senior, hands-on scientific and operational leadership role. You will define and implement Draig's DMPK strategy, manage outsourced studies, and integrate translational PK/PD understanding into development decisions. The successful candidate will bring deep expertise across nonclinical and clinical ADME, bioanalysis, and modelling to ensure robust, regulatory-compliant data packages that enable progression of Draig's development pipeline.

Strategic and Scientific Leadership

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.

Operational Oversight and Delivery

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.

Integration and Cross-Functional Collaboration

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.

Scientific Influence and Organisational Growth

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.

Education and Experience:

• 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 Skills:

• 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.

Why Join the Draig Development Team?

This is a unique opportunity to take scientific and strategic ownership of DMPK at a dynamic, well-funded biotech with a pioneering CNS pipeline. As Development DMPK Director (Senior Director), you will work at the interface of discovery, nonclinical, and clinical development — shaping Draig's translational PK strategy and directly influencing the success of its innovative programmes. You'll play a central role in advancing small-molecule candidates from the lab to the clinic, contributing to transformative therapies for patients worldwide.

Competencies:

Adaptability
: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration
: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Execution
: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Location: Metro Boston, USA, London, UK and Cardiff, UK

TO ALL AGENCIES:
Please, no phone calls or emails to any employee of Draig about our openings. All resumes submitted by search firms/employment agencies to any employee at Draig Therapeutics via email, the internet, or in any form and/or method will be deemed the sole property of Draig Therapeutics unless Draig engaged such search firms/employment agencies for this position and a valid agreement with Draig is in place. In the event a candidate who was submitted outside of the Draig Tx agency engagement process is hired, no fee or