Associate Medical Director, Clinical Development (Medical Monitor)

Beeline Medicines•Boston, MA

2d•Hybrid

About The Position

The Associate Medical Director, Clinical Development (Medical Monitor) plays a critical role in ensuring the safety, scientific integrity, and regulatory compliance of clinical trials within the company's immunology and inflammation portfolio. As a key medical expert embedded within the Clinical Development organization, this individual provides real-time medical oversight of ongoing studies, serves as a primary point of contact for investigative site medical inquiries, and contributes to the design and review of clinical trial documents. The Medical Monitor collaborates closely with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to support the execution of Phase I–III trials in lupus and adjacent I&I indications.

Requirements

Medical degree (MD or DO) required
Board certification or eligibility in immunology, rheumatology, nephrology, internal medicine, or a related specialty strongly preferred.
Minimum of 3 years of pharmaceutical / biotech industry experience or research / hospital setting in clinical development, medical monitoring, or drug safety; clinical practice experience in relevant specialty is highly valued.
Direct experience serving as a Medical Monitor or Clinical Scientist on Phase II–III clinical trials, ideally in autoimmune, immunology, or inflammation indications
Thorough understanding of ICH E6 GCP guidelines, FDA and EMA regulatory requirements, and applicable industry standards for clinical trial conduct and safety reporting.
Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
Exhibits sound judgment and decisiveness in high-stakes situations; models intellectual curiosity, scientific rigor, and ethical integrity as core leadership behaviors.
Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners.
Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and other stakeholders.
Adept at facilitating productive dialogue in high-stakes meetings, negotiations, and multi-party collaborations; balances clarity, diplomacy, and scientific precision.
Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive decision-making.

Responsibilities

Provide continuous medical monitoring oversight for assigned clinical trials, including real-time review of adverse events, serious adverse events (SAEs), and clinical laboratory data to assess patient safety and protocol compliance.
Serve as the primary medical point of contact for investigative sites, responding to clinical and safety inquiries in a timely, accurate, and compliant manner.
Review and contribute to the development of clinical documents including protocols, protocol amendments, investigator brochures (IB), informed consent forms (ICFs), and clinical study reports (CSRs).
Contribute to the design and ongoing evaluation of risk-based monitoring plans and data review strategies in collaboration with Clinical Operations and Data Management.
Participate in the review and medical assessment of individual patient data, including clinical narratives for SAEs, SUSAR reports, and other safety events requiring medical judgment.
Collaborate with the Pharmacovigilance team on expedited safety reporting, Data Safety Monitoring Board (DSMB) preparation, and aggregate safety assessments.
Ensure protocol adherence and Good Clinical Practice (GCP) compliance at investigative sites by supporting clinical monitoring activities and contributing to site oversight plans.
Support the preparation and review of regulatory submissions, including IND annual reports, clinical sections of INDs and NDAs/BLAs, and responses to health authority queries.
Participate in cross-functional study teams, providing medical input on trial design, endpoint selection, eligibility criteria, and patient safety strategy.
Contribute to the evaluation of medical literature and competitive intelligence relevant to the therapeutic area and clinical program strategy.
Perform other duties and responsibilities as assigned