Avalo Therapeutics
Medical Director/Sr. Medical Director, Clinical Development
Chesterbrook, PA · Director
Sponsorship not specifiedDetected 33 days ago
GCPHRClinical TrialsClinical ResearchPharmacologyFDA RegulatoryPharmacovigilanceResearchLeadershipRegulatory Affairs
About the role
- 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.
- Provide medical leadership and oversight for assigned clinical program(s).
- Serve as Medical Monitor for ongoing clinical studies, including review of eligibility criteria, safety data, adverse events, protocol deviations, and dose escalation decisions.
Responsibilities
- Contribute to early clinical development strategy, including dose selection and clinical trial design, safety monitoring, biomarker strategy, and proof-of-mechanism approaches.
- Collaborate closely with Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Pharmacovigilance, CROs, and external vendors to support high-quality study execution.
- 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.
- Develop and maintain relationships with investigators, key opinion leaders (KOLs), advisory boards, and scientific experts.
- Maintain awareness of scientific advancements, emerging therapies, and competitive developments within rheumatology, immunology, and inflammatory diseases.
Requirements
- 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.
- Strong understanding of early clinical development, dose escalation methodologies, safety monitoring, and translational medicine principles.
- Minimum of 5+ years of biotechnology, pharmaceutical, academic medicine, clinical research, or related clinical development experience.
Nice 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.
- Experience supporting IND submissions and early regulatory interactions preferred.
- Experience working within small or emerging biotechnology companies preferred.
- About Avalo Therapeutics
- Positive topline data was recently reported for abdakibart in a Phase 2 clinical trial in hidradenitis suppurativa (HS).
- In addition to HS, we're exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs.
- For more information about Avalo, please visit www.avalotx.com.
Benefits
- Support regulatory interactions, including IND submissions, briefing documents, and responses to health authority inquiries.
Company info
- Ensure studies are conducted in compliance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements.
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