Associate Director​/Director, Clinical Science & Development

Associate Director / Director, Clinical Science & Development Company Overview

ModeX Therapeutics, an OPKO Health company, is the leading clinical‑stage biopharmaceutical company developing unique and proprietary‑multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first‑in‑class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, and several of the world’s most pressing viral threats.

The founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, visit

The Associate Director / Director of Clinical Science & Development will be a key member of project, research, and clinical development teams. The role will play a critical role in driving clinical development results for our oncology, immune impairment, infectious diseases and cell therapy programs in development.

This position requires a general understanding of key therapeutic areas, excellent communication, collaboration and leadership skills, and an awareness of business principles. This role requires working in a matrixed team environment with Research, CMC, Clinical, Quality, Regulatory, and Program Management functions.

This posting represents a single opening in which either an Associate Director or Director level candidate will be selected based on experience and qualifications.

• Support Program Lead and Medical Monitor with program strategy and execution, and target product profile in line with the early development program, commercial strategy and regulatory needs.
• In collaboration with Program Lead, prepare presentations to obtain endorsement of the clinical strategic plan with the appropriate governance committees.
• Support liaison with different functions with expertise and leadership (data management, biostatistics, medical writing, pharmacovigilance, regulatory, clinical operations, translational medicine) as well as interact with and support Program team members and project management.
• Support the preparation of key clinical documents to be prepared for clinical trials (protocols, amendments, benefit risk assessments), interactions with internal governance bodies, external partners, key opinion leaders, investigators.
• Build and maintain a strong network of external vendors.
• Support authoring briefing packages for submission to health authorities, and work in collaboration with regulatory product manager to devise strategy for path to regulatory approval and interactions with health authorities.
• Maintain deep scientific, technical, and clinical expertise in immuno‑oncology drug development.
• Partner with internal competitive intelligence SME to evaluate relevant literature, data and the status from competitive products; provide clinical landscape and benchmark updates to Program Lead.
• Support clinical reviews of data listings, patient profiles, and essential study data within statistical reports and partner with Medical Monitoring and Data Management/Operations in generating relevant queries.
• Support and/or generate in‑house tables/listing and figures to facilitate internal discussions.

• Advanced degree (MS, RN, or MBA; PhD scientist and Biomedical Science master is a plus).
• 7‑10+ years of relevant professional experience, including 5+ years of industry experience required; industry experience should include both research and clinical development.
• Salary $180K‑$210K.

• Advanced degree (MS, RN, or MBA; PhD scientist and Biomedical Science master is a plus).
• 10‑12+ years of relevant professional experience, including 5+ years of industry experience required; industry experience should include both research and clinical development.
• Salary $210K‑$250K.

• Proficient in clinical literature and critical interpretation of clinical study results.
• Experience with…