Sr. Director/Executive Director, Head Clinical Pharmacology

Avalo Therapeutics•Chesterbrook, PA

About The Position

Avalo Therapeutics is seeking a Senior/Executive Director, Head of Clinical Pharmacology to provide strategic and scientific leadership across its clinical development programs, primarily focused on monoclonal antibody therapeutics for immune-mediated inflammatory diseases. The role integrates pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity, efficacy, and safety findings to guide dose and regimen selection, clinical study design, and regulatory strategy. It includes leadership of clinical pharmacology plans for abdakibart, including its development in hidradenitis suppurativa and additional indications, and for AVTX-010, a long-acting anti-IL-1β monoclonal antibody. The role leads dose and regimen justification; population PK, PK/PD, and exposure–response analyses; and the interpretation of immunogenicity and other clinical data. It provides clinical pharmacology expertise across study planning, protocols, regulatory submissions, health authority interactions, formulation and delivery-system changes, and potential registration and labeling. The position collaborates across clinical development, translational medicine and biomarkers, biostatistics, clinical operations, regulatory affairs, CMC, laboratories, and external partners. As Avalo’s clinical pharmacology subject-matter expert, the Head establishes scalable processes appropriate for a growing organization, selects and manages external consultants and service providers, and ensures scientific deliverables meet quality, timeline, and budget expectations. The role calls for substantial direct experience developing monoclonal antibodies, including late-stage development, and the ability to translate quantitative analyses into clear development recommendations.

Requirements

PhD, PharmD, MD, or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a 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.
Strong scientific judgment and quantitative reasoning, with the ability to make practical recommendations from incomplete or complex data.
Ability to balance strategic priorities with hands-on execution, manage competing deadlines, and collaborate effectively across internal and external teams.

Nice To Haves

Experience developing therapies for immunology, inflammatory diseases, or dermatology; hidradenitis suppurativa 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.

Responsibilities

Develop and execute integrated clinical pharmacology plans for Avalo’s clinical development programs, including abdakibart and AVTX-010.
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 and maintenance doses, dosing intervals, and alternative regimens.
Partner with cross-functional teams to incorporate clinical pharmacology into program decisions and provide input on new indications and pipeline opportunities.
Provide clinical pharmacology input into development plans, protocols, investigator brochures, analysis plans, and clinical study reports.
Define practical PK, PD, and immunogenicity sampling schedules that balance scientific objectives, patient burden, and operational feasibility.
Lead integrated interpretation of anti-drug antibody and neutralizing antibody findings and their effects on exposure, PD, efficacy, and safety.
Partner with bioanalytical and translational experts on assay readiness and suitability, including sensitivity, drug tolerance, target interference, and interpretation of total versus free drug or target measurements where relevant.
Collaborate with Clinical Operations, Data Management, laboratories, and analysis partners on sample handling, reliable datasets, and timely scientific reporting.
Evaluate how disease activity, inflammatory burden, body weight, albumin, and other patient characteristics affect PK and clinical response.
Guide assessment of subcutaneous absorption, bioavailability, and dosing considerations for monoclonal antibodies.
Lead the strategy, oversight, and interpretation of population PK, PK/PD, and exposure–response analyses.
Oversee selection of vendors for modeling and PK and biomarker assays; oversee external pharmacometrics partners and assess their assumptions, methods, and conclusions.
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 exposure–outcome relationships.
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.
Lead clinical pharmacology contributions to regulatory submissions, briefing documents, and responses to health authority questions.
Develop integrated clinical pharmacology and dose-justification narratives to support registration and proposed labeling; represent the function in regulatory interactions and cross-functional governance discussions.
Partner with CMC and device-development colleagues on clinical pharmacology implications of formulation, manufacturing, and delivery-system changes.
Define PK comparability or bridging strategies as needed and support evaluation of subcutaneous delivery approaches, including prefilled syringes and autoinjectors where relevant.
Serve as Avalo’s clinical pharmacology subject-matter expert and establish scalable processes for a growing organization.
Select and manage external consultants, pharmacometrics providers, and other relevant partners, ensuring deliverables meet quality, timeline, and budget expectations.