Senior Director, Clinical Pharmacology - San Diego, CA

Summary

The Senior Director, Clinical Pharmacology is accountable for the oversight and delivery of Mirador’s Phase 1 studies and serves as Study Director for several studies concurrently, from protocol concept through clinical study report. The position owns protocol authoring and amendments, the day-to-day sponsor interface with Phase 1 units and contract research organizations, and study-level budgets, timelines and vendor management, working in close partnership with Clinical Operations. The role also supports the operational regulatory documents that keep our INDs current (IND modules and amendments, annual reports and DSURs, and responses to health authority information requests) and contributes to the clinical pharmacology needs of later-phase programs and in-licensing diligence, including clinical pharmacology development plans and the recommended Phase 2 dose. The position reports to the Vice President, Early Clinical Development & Pharmacology.

We are seeking a hands-on early development leader who has carried programs rather than advised on them. This role provides the scientific and operational leadership that takes each study from a well-designed protocol to a clean, interpretable dataset. The incumbent is expected to apply pharmacokinetic/pharmacodynamic and model-informed drug development principles as needed to inform study design, dose selection, and data interpretation. The role works closely with Clinical Operations, R&D (biomarker and translational support), Medical Writing, Regulatory Affairs, Biostatistics and Data Management, and our external partners.

Responsibilities

• Serve as Study Director for several concurrent Phase 1 studies, including first-in-human single- and multiple-ascending-dose studies and clinical pharmacology studies (e.g., relative bioavailability, formulation or device bridging, drug interaction and special population studies), with accountability for scientific integrity, quality, and timelines from protocol concept through clinical study report.
• Author, in collaboration with Medical Writing, Phase 1 protocols and protocol amendments and lead their cross-functional review and approval. Co-develop the scientific rationale for study design and dose selection with the Head of function, and own its translation into protocol text, dose-escalation and stopping rules, and PK/PD and biomarker sampling schemes.
• Act as the sponsor’s primary day-to-day interface with Phase 1 units, investigators and CROs: lead study team meetings, track start-up, enrollment, dosing and data flow, anticipate risks and drive issues to resolution to keep studies on plan.
• Partner with the study medical monitor to run safety review committee and dose-escalation meetings, ensuring integrated safety, PK and PD data are available, reviewed and documented to support each escalation decision.
• With Clinical Operations, select, contract and manage study vendors (CROs, Phase 1 units, bioanalytical, biomarker and central laboratories, and data systems); scope work orders and change orders and hold vendors accountable to quality, timeline, and budget commitments.
• Own data quality from first subject dosed through database lock: review safety, PK, PD and biomarker data in near real time, drive data cleaning and query resolution with Data Management and the CRO, and oversee bioanalytical sample logistics and PK data reconciliation.
• Lead study analysis and reporting: provide input to statistical analysis plans, oversee noncompartmental PK analysis and PK/PD summaries, lead the interpretation of safety, PK, PD and biomarker results, and author or direct the clinical study report and its clinical pharmacology sections; present results to program teams and governance.
• Support operational regulatory deliverables for Mirador’s INDs in partnership with Regulatory Affairs: author and review the clinical and clinical pharmacology content of IND modules and amendments, Investigator’s Brochure updates, annual reports and DSURs, and responses to health authority information requests, keeping each IND current and compliant.
• Prepare study-level content for regulatory briefing documents and meeting packages and support the Head of function in health authority interactions.
• Support the clinical pharmacology needs of later-phase programs: contribute to clinical pharmacology development plans, integrated PK/PD and exposure–response summaries, and the rationale for the recommended Phase 2 dose and regimen.
• Support in-licensing due diligence by evaluating the clinical pharmacology and Phase 1 data packages of external assets, identifying gaps and risks, and contributing to the clinical pharmacology assessment.
• Apply PK/PD and model-informed drug development approaches as needed to inform study design, dose selection and data interpretation, and oversee pharmacometric deliverables from vendors and consultants, in alignment with the function’s PK/PD and MIDD strategy.
• Represent Clinical Pharmacology and Early Clinical Development on program teams for Phase 1 assets; partner with R&D to integrate biomarker and translational endpoints into Phase 1 designs and to ensure sample collection, assay readiness and data flow support the proof-of-concept plan.
• Contribute to internal process improvement, including SOPs, templates and study-level quality documentation, and maintain inspection readiness for sponsor-owned Trial Master File content.
• Contribute to hiring, onboarding and mentoring as the team grows.

Experience and Qualifications

• PhD, PharmD or equivalent experience in clinical pharmacology, pharmacology, pharmaceutical sciences or a related discipline. Candidates are assessed on demonstrated program delivery rather than on degree.
• 10 or more years of biotech or pharmaceutical industry experience in early clinical development, with a track record of delivering Phase 1 studies as the sponsor’s accountable lead.
• Has served as Study Director (or equivalent sponsor lead) on first-in-human studies, including dose-escalation studies in healthy volunteers and/or patients.
• Has authored and amended clinical protocols and has kept an IND current, including IND amendments, annual reports or DSURs, and responses to information requests.
• Working knowledge of PK/PD and model-informed drug development sufficient to design sampling schemes, interpret noncompartmental and exposure–response outputs and critically review pharmacometric deliverables; hands-on modeling experience (e.g., Phoenix WinNonlin, NONMEM, R) is a plus.
• Experience in immunology or inflammation and across modalities (biologics and small molecules) is a plus.
• Experience contributing to later-phase clinical pharmacology deliverables (clinical pharmacology plans, Phase 2 dose selection) or to due diligence assessments is a plus.
• Familiarity with related disciplines (bioanalysis, biomarkers, biostatistics, data management, toxicology, regulatory) in the drug development process.

Skills and Abilities

• Hands-on, delivery-oriented style with a sense of urgency and a bias toward action; comfortable owning outcomes end to end in a small team.
• Thorough understanding of ICH Good Clinical Practice and of the regulatory requirements governing Phase 1 conduct, IND maintenance and safety reporting, with sound judgment on protocol deviations, documentation and inspection readiness.
• Strong protocol and regulatory writing skills; clear, precise written and oral communication with close attention to detail.
• Ability to lead cross-functional study teams and external partners to outcomes without direct authority.
• Project and financial management discipline; builds credible budgets and timelines and manages to them.
• Scientific acumen to integrate safety, PK, PD and biomarker data into dose-escalation and go-forward recommendations.
• Ability to work on several studies and programs at the same time and prioritize effectively.
• Demonstrated ability to be flexible and adaptable to change; a fast learner willing to take on new therapeutic areas.
• A commitment to collaborative leadership, teamwork and delegation, and to fostering a professional culture based on trust and mutual respect.
• Up to 10% travel.

Job level may vary depending on experience and qualifications. The expected base pay range for this position is $250,000 - $300,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

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