EPM Scientific
Associate Director, Clinical Operations
A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting‑edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune‑mediated conditions. Be part of a team where innovation meets purpose‑and help shape the next generation of therapies.
Base pay range $145,000.00/yr - $215,000.00/yr
Base Salary:
$145K-$215K USD + Bonus | Full‑Time | Remote
Key Responsibilities
Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications.
Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards.
Own budgets, timelines, and risk mitigation plans for all clinical programs.
Collaborate cross‑functionally with Clinical Development, Regulatory, Data Management, and Quality teams.
Drive inspection readiness and ensure audit preparedness.
Qualifications
Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role.
Proven track record managing global trials and CROs.
Strong knowledge of GCP, ICH, and regulatory requirements.
Immunology or inflammatory disorder experience preferred.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Health Care Provider
Industries Medical and Diagnostic Laboratories
Cambridge, MA
#J-18808-Ljbffr
A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting‑edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune‑mediated conditions. Be part of a team where innovation meets purpose‑and help shape the next generation of therapies.
Base pay range $145,000.00/yr - $215,000.00/yr
Base Salary:
$145K-$215K USD + Bonus | Full‑Time | Remote
Key Responsibilities
Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications.
Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards.
Own budgets, timelines, and risk mitigation plans for all clinical programs.
Collaborate cross‑functionally with Clinical Development, Regulatory, Data Management, and Quality teams.
Drive inspection readiness and ensure audit preparedness.
Qualifications
Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role.
Proven track record managing global trials and CROs.
Strong knowledge of GCP, ICH, and regulatory requirements.
Immunology or inflammatory disorder experience preferred.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Health Care Provider
Industries Medical and Diagnostic Laboratories
Cambridge, MA
#J-18808-Ljbffr