Medical Director/Sr. Medical Director, Clinical Development- Dermatology

Avalo Therapeutics•Chesterbrook, PA

About The Position

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: The Medical Director/Senior Medical Director, Clinical Development will play a key leadership role in advancing Avalo Therapeutics' late-stage clinical development program focused on Hidradenitis Suppurativa (HS). This individual will provide medical leadership for Avalo's global Phase III clinical trial, partnering closely with Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Pharmacovigilance, and other cross-functional teams to ensure successful study execution, patient safety, and high-quality data generation. The successful candidate will possess deep expertise in dermatology clinical development, with experience supporting clinical trials in immune-mediated skin diseases and biologic therapies. This individual will serve as the medical lead for ongoing studies, working closely with investigators, CROs, and key opinion leaders while contributing to regulatory strategy, data interpretation, scientific communications, and future lifecycle planning. The ideal candidate thrives in a collaborative biotechnology environment and enjoys working in a hands-on, cross-functional role where they can directly influence clinical development strategy and execution.

Requirements

MD or equivalent medical degree required.
Minimum 5–10 years of biotechnology, pharmaceutical, academic medicine, or clinical development experience.
Significant experience supporting or leading late-stage (Phase II/III) dermatology clinical development programs.
Experience serving as a Medical Monitor for multicenter clinical trials strongly preferred.
Demonstrated experience in Dermatology, with expertise in inflammatory skin diseases such as Hidradenitis Suppurativa, psoriasis, atopic dermatitis, alopecia areata, vitiligo, lupus, or other immune-mediated dermatologic conditions.
Experience supporting the development of biologics, monoclonal antibodies, or immunology-focused therapies.
Experience reviewing and interpreting clinical efficacy, safety, PK/PD, biomarker, and patient-reported outcome data.
Experience collaborating with CROs, vendors, and global investigator sites throughout clinical trial execution.
Strong understanding of FDA, EMA, ICH-GCP, and global regulatory requirements.
Previous experience supporting regulatory submissions (IND, BLA, NDA, or equivalent) preferred.
Excellent scientific communication and presentation skills with the ability to influence cross-functional teams and external stakeholders.

Nice To Haves

Board certification or formal clinical training in Dermatology strongly preferred.
Prior experience supporting clinical development programs in Hidradenitis Suppurativa (HS) highly preferred.
Experience with biologic therapies targeting inflammatory or immune-mediated dermatologic diseases.
Experience leading or supporting global Phase III registration studies.
Established relationships with dermatology investigators and Key Opinion Leaders.
Experience working within a small or emerging biotechnology company where cross-functional collaboration and hands-on leadership are essential.
Demonstrated ability to work effectively in a fast-paced, evolving clinical development environment.

Responsibilities

Serve as the Medical Lead and Medical Monitor for Avalo's global Phase III Hidradenitis Suppurativa (HS) clinical development program.
Provide medical oversight throughout study conduct, including eligibility review, protocol compliance, safety surveillance, adverse event review, endpoint adjudication, and protocol deviation assessment.
Partner closely with Clinical Operations and CRO partners to ensure efficient execution of global multicenter clinical trials, proactive issue resolution, and achievement of enrollment and study milestones.
Collaborate with Translational Medicine, Biometrics, Pharmacovigilance, Regulatory Affairs, Clinical Pharmacology, CMC, and Quality Assurance to support integrated clinical development activities.
Analyze and interpret emerging efficacy, safety, pharmacokinetic/pharmacodynamic (PK/PD), biomarker, and patient-reported outcome data to support clinical decision-making and program advancement.
Contribute to the development and review of clinical protocols, protocol amendments, Investigator Brochures, Clinical Study Reports, informed consent documents, statistical analysis plans, regulatory briefing documents, and other clinical development deliverables.
Participate in Safety Review Committees, Data Monitoring Committee interactions, cross-functional data review meetings, and benefit-risk assessments.
Support regulatory interactions, including IND amendments, BLA/NDA preparation, health authority briefing documents, and responses to regulatory agency questions.
Build and maintain strong relationships with dermatology investigators, clinical trial sites, CRO partners, patient advocacy organizations, and global Key Opinion Leaders specializing in HS and inflammatory skin diseases.
Present clinical and scientific data at investigator meetings, advisory boards, scientific congresses, and internal governance meetings.
Monitor advancements in dermatology, Hidradenitis Suppurativa, biologic therapies, inflammatory skin diseases, and the competitive landscape to inform development strategy.
Ensure all clinical activities comply with ICH-GCP, FDA and global regulatory requirements, company SOPs, and ethical standards.
Contribute to publication strategy, scientific communications, and future lifecycle management opportunities supporting Avalo's dermatology portfolio.
Perform other duties as assigned.