Sr. Director/Executive Director, Head Clinical Pharmacology

Avalo Therapeutics; Chesterbrook (PA); Sur place; USD 190 000 - 240 000; Plein temps

Résumé du poste

Avalo Therapeutics seeks a Senior/Executive Director, Head of Clinical Pharmacology to lead pharmacology strategy across monoclonal antibody programs for IAID diseases. Focus on integrating PK/PD, biomarkers, and immunogenicity to guide dose, design, and regulatory plans.

Ideal candidate has deep monoclonal antibody experience, strong leadership, and a track record in Phase 2/3 development and regulatory submissions.

Qualifications

• PhD/MD/PharmD or equivalent advanced degree in Clinical Pharmacology or related field.
• 12+ years in pharma/biotech with clinical pharmacology leadership.
• Direct monoclonal antibody development experience in late-stage programs.

Responsabilités

• Develop and own integrated clinical pharmacology plans across programs.
• Lead dose justification and regimens for mAb programs.
• Collaborate with cross-functional teams to inform regulatory strategy.
• Oversee PK/PD, ADA/NAb analyses and biomarker strategies.
• Represent pharmacology in regulatory submissions and health authority interactions.

Connaissances

Pharmacology Strategy

Monoclonal antibodies

Dose selection

Regulatory submissions

Leadership

Formation

PhD or MD or PharmD

Outils

PK/PD modeling

Description du poste

At Avalo (ahh-vah’-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.

We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

Position Summary:

Avalo Therapeutics is seeking a Senior/Executive Director, Head of Clinical Pharmacology to provide strategic and scientific leadership across its clinical development programs, with a primary focus on monoclonal antibody therapeutics for immune-mediated inflammatory diseases.

The Senior/Executive Director, Head of Clinical Pharmacology will be accountable for integrating pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity, efficacy, and safety findings to guide dose and regimen selection, clinical study design, and regulatory strategy. The role requires substantial direct experience developing monoclonal antibodies, particularly in late-stage clinical development, and the ability to translate quantitative analyses into clear development decisions.

Essential Duties and Responsibilities:

Clinical Pharmacology Strategy and Program Leadership

• Develop and execute integrated clinical pharmacology plans supporting Avalo’s clinical development programs, including the advancement of abdakibart in HS and additional indications for abdakibart. The Head of Clinical Pharmacology will also oversee clinical pharmacology plans for AVTX-010, our long-acting anti-IL-1β monoclonal antibody.
• Establish clinical pharmacology priorities that address key development questions and support late-stage development and registration.
• Lead dose and regimen justification, including evaluation of loading doses, maintenance doses, dosing intervals, and alternative regimens.
• Partner with Clinical Development, Translational Medicine & Biomarkers, Biostatistics, Clinical Operations, Regulatory Affairs, and CMC to incorporate clinical pharmacology into program decisions.
• Present recommendations, assumptions, uncertainties, and development risks to program teams and senior leadership; provide clinical pharmacology input into new indications and pipeline opportunities.

Monoclonal Antibody Expertise

• Provide clinical pharmacology input into development plans, protocols, investigator brochures, analysis plans, and clinical study reports; define PK, PD, and immunogenicity sampling schedules that balance scientific objectives, patient burden, and operational feasibility.
• Lead integrated interpretation of anti-drug antibody (ADA) and neutralizing antibody (NAb) findings and their impact on exposure, PD, efficacy, and safety.
• Partner with bioanalytical and translational experts to ensure assay readiness and suitability, addressing sensitivity, drug tolerance, target interference, and interpretation of total versus free drug or target measurements, as relevant.
• Collaborate with Clinical Operations, Data Management, laboratories, and analysis partners to ensure appropriate sample handling, reliable datasets, and timely scientific reporting.
• Evaluate the impact of disease activity, inflammatory burden, body weight, albumin, and other patient characteristics on PK and clinical response.
• Guide assessment of subcutaneous absorption, bioavailability, and dosing considerations relevant to monoclonal antibody development.

Pharmacometrics and Dose Optimization

• Lead the strategy, oversight, and interpretation of population PK, PK/PD, and exposure–response analyses.
• Oversee selection of relevant vendors for modeling, PK and biomarker assays.
• Use modeling and simulation to support dose selection, confirm dosing regimens, and inform clinical study design.
• Integrate PK, biomarker, efficacy, safety, and immunogenicity results to characterize relationships between exposure and clinical outcomes.
• Evaluate whether patient characteristics or concomitant treatments warrant additional analyses or dosing considerations.
• Develop scientifically justified approaches to special-population assessments and potential study waivers, where appropriate for monoclonal antibodies.
• Oversee external pharmacometrics partners and critically assess modeling assumptions, analytical methods, and conclusions.

Clinical Development and Regulatory Support

• Provide clinical pharmacology input into clinical development plans, protocols, investigator brochures, analysis plans, and clinical study reports.
• Design practical PK, PD, and immunogenicity sampling schedules that balance scientific objectives, patient burden, and study feasibility.
• Lead clinical pharmacology contributions to regulatory submissions, briefing documents, and responses to health authority questions.
• Develop integrated clinical pharmacology and dose-justification narratives supporting registration and proposed labeling.
• Represent the clinical pharmacology function in regulatory interactions and cross-functional governance discussions.

CMC, Formulation, and Delivery-System Collaboration

• Partner with CMC and device-development colleagues to assess the clinical pharmacology implications of formulation, manufacturing, or delivery-system changes.
• Define PK comparability or bridging strategies, as needed, to support development and commercialization.
• Support evaluation of subcutaneous delivery approaches, including prefilled syringes and autoinjectors, where relevant to program plans.

Functional Leadership and External Partner Management

• Serve as Avalo’s clinical pharmacology subject-matter expert and establish scalable processes appropriate for a growing organization.
• Select and manage external consultants, pharmacometrics providers, and other relevant partners.
• Ensure scientific deliverables meet quality, timeline, and budget expectations.

Required Education and Experience:

• PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or related discipline.
• 12 or more years of relevant pharmaceutical or biotechnology industry experience, including leadership of clinical pharmacology activities.
• Substantial direct experience with monoclonal antibody therapeutics, including ownership of clinical pharmacology strategy, dose selection, and dose justification.
• Experience supporting Phase 2 and Phase 3 clinical development and registration-enabling activities.
• Strong expertise in biologics PK/PD, population PK, exposure–response analysis, and immunogenicity assessment.
• Demonstrated ability to interpret quantitative analyses and translate results into clear clinical development recommendations.
• Experience preparing clinical pharmacology sections of regulatory submissions and supporting health authority interactions.
• Demonstrated success managing external consultants and service providers.
• Strong scientific writing, presentation, and cross-functional influencing skills.
• Ability to combine strategic leadership with direct scientific execution in a lean biotechnology environment.

Preferred Qualifications

• Experience developing therapies for immunology, inflammatory diseases, or dermatology; HS experience is a plus.
• Experience with anti-cytokine monoclonal antibodies and interpretation of inflammation-related effects on PK.
• Direct involvement in a BLA submission, including integrated clinical pharmacology analyses and regulatory responses.

Additional Skills, Knowledge, and/or Abilities:

• Strong scientific judgment, quantitative reasoning, and ability to make practical recommendations from incomplete or complex data.
• Clear scientific writing and presentation skills, effective cross-functional influence, and accountability for decisions and deliverables.
• Ability to balance strategic priorities with hands‑on execution, manage competing deadlines, and collaborate effectively across internal and external teams.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune-mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next‑generation anti-IL-1β mAb. For more information about Avalo, please visit www.avalotx.com.

ATTENTION: External Agencies and Placement Firms

A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalyo and prior to submitting any resume or CV.

All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e‑mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.