Associate Director, Clinical Science

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assist in the implementation of clinical development strategies for candidate drug products alongside Project Leaders and Medical Directors.

• Execute clinical studies and oversee data in real-time to maintain study integrity.

• Actively identify and escalate any issues encountered during trial execution.

• Conduct comprehensive clinical data reviews focusing on quality and patient safety.

• Work in collaboration with data management, clinical operations, and medical monitors on clinical data assessments.

• Communicate and escalate concerns both internally and to investigators.

• Collaborate on EDC development according to protocol requirements.

• Draft and review clinical documents, including concept sheets/decks, clinical study protocols, investigator brochures, and regulatory submissions.

• Generate clinical outputs and provide preliminary interpretations for internal use and external engagements.

• Review Tables/Listings/Figures and SAP updates with Biostatistics, Pharmacovigilance, and other relevant stakeholders.

• Participate in regular study team meetings representing clinical development.

• Organize and present information, study designs, and data to advisory boards, investigator meetings, site interactions, study committees, and both internal and external audiences.

• Execute other duties and responsibilities as assigned.

⛳️ Requirements

• PhD or equivalent with 5+ years of relevant experience, or a bachelor/master’s degree with 10+ years of postgraduation experience.

• Experience in the pharmaceutical industry pertaining to clinical drug/biologics development and related regulatory processes.

• Strong organizational abilities for data collection and documentation supporting clinical trial analysis and interpretation.

• Capability to effectively interact with internal team members and external partners.

• Experience in clinical data analysis.

• Ability to influence decision-making within a multidisciplinary team in relevant fields of expertise.

• Outstanding communication and presentation skills.

• Up to 20% travel for business may be necessary.

• Preferred experience across Phase I–III drug development trials.

• Preferred product development experience in Hematology-Oncology and/or rare diseases.

🏝️ Benefits

• Equity-based compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company matching.

• Life insurance.

• Flexible spending accounts for healthcare and/or dependent care.

• Annual performance bonus.

• Long-term incentive plan.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional growth.