New · posted Oct 31
Avalo Therapeutics · Biotechnology
Medical Director/Sr. Medical Director, Clinical Development- Rheumatology
- Chesterbrook, PA
- On-site
- Full-time
- Director
The role
The Medical Director will provide medical support and input to Avalo’s clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives. The Medical Director will be responsible for collaborating with clinical operations, regulatory, translational medicine/biomarkers, clinical pharmacology, CMC, and quality assurance functions; liaising with clinical investigators and site personnel; and establishing and building relationships with key external experts. The position requires a leader with experience working with CROs and vendors and interfacing with investigator sites to ensure operational efficiency and effective execution of trials within a complex, fast-paced environment.
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.
What you need
Required Education and Experience
- MD or equivalent medical degree required.
- Background or therapeutic experience in Rheumatology, Immunology, Autoimmune Disease, or related inflammatory conditions.
- Minimum of 5+ years of biotechnology, pharmaceutical, academic medicine, clinical research, or related clinical development experience.
- Direct clinical experience supporting or leading late-stage (phase 2/3) drug development clinical studies required.
- Experience with or exposure to the development of biologic therapies is desirable.
- Previous regulatory submission experience a plus (e.g., NDA, BLA, etc.)
- Strong understanding of early clinical development, dose escalation methodologies, safety monitoring, and translational medicine principles.
- Experience reviewing and interpreting clinical safety, efficacy, PK/PD, and biomarker data.
Preferred Qualificationsnice to have
- Clinical training, board certification, or board eligibility in Rheumatology or related specialty preferred.
- Experience with biologics, monoclonal antibodies, or immune-mediated inflammatory diseases.
- Prior Medical Monitoring experience is strongly preferred.
- Experience supporting IND submissions and early regulatory interactions preferred.
- Experience working within small or emerging biotechnology companies preferred.
What you'll do
- Provide medical leadership and oversight for assigned clinical program(s).
- Contribute to early clinical development strategy, including dose selection and clinical trial design, safety monitoring, biomarker strategy, and proof-of-mechanism approaches.
- Support the design, review, and execution of clinical protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory documents in compliance with clinical development plans, GCP, and good medical practice.
- Serve as Medical Monitor for ongoing clinical studies, including review of eligibility criteria, safety data, adverse events, protocol deviations, and dose escalation decisions.
- Collaborate closely with Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Pharmacovigilance, CROs, and external vendors to support high-quality study execution.
- Provide medical writing support in preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling.
- Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials, and develop and implement risk management strategies.
- Participate in Safety Review Committees, data review discussions, and cross-functional development activities.
- Analyze, interpret and communicate emerging clinical, PK/PD, biomarker, and safety data to internal and external stakeholders.
- Support regulatory interactions, including IND submissions, briefing documents, and responses to health authority inquiries.
- Develop and maintain relationships with investigators, key opinion leaders (KOLs), advisory boards, and scientific experts.
- Present clinical and scientific findings internally and externally, including investigator meetings and scientific conferences.
- Maintain awareness of scientific advancements, emerging therapies, and competitive developments within rheumatology, immunology, and inflammatory diseases.
- Ensure studies are conducted in compliance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements.
Where you'll work
Chesterbrook, PAOn-siteOpen in Maps (opens in a new tab)
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From the posting
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.
Equal opportunity, accessibility and legal noticesAvalo Therapeutics's statements, word for word
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 Avalo 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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
Director roles in the US93 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $258,000 | $298,000 | $318,500 |
Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 116 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Avalo Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct12
- Collaboration and leadership8
- Documentation and SOPs6
- Investigations and CAPA5
- Regulatory submissions4
- GMP and compliance2
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
Avalo Therapeutics on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory1 33%
- Quality1 33%
- Clinical1 33%
By level
- Director2 67%
- Manager1 33%
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Medical Director/Sr. Medical Director, Clinical Development- Rheumatology at Avalo Therapeutics
Open until filled.