Associate Director, Clinical Science

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

📋 Description

• The Associate Director Clinical Scientist plays a crucial role in implementing the clinical development strategy for candidate drug products, working closely with Project Leaders and Medical Directors.

• This role involves operationalizing clinical studies, continuously monitoring data to ensure study integrity, and proactively identifying any issues that may arise during trials.

• The individual will be responsible for conducting medical reviews and data analyses aimed at both data cleaning and interpretation for regulatory submissions and publications.

• Ongoing clinical data monitoring: Conduct high-level reviews of clinical data to ensure quality and patient safety, escalating issues to the medical director as necessary.

• Collaborate effectively with data management, clinical operations, and medical monitors to ensure that clinical data reviews are executed efficiently and meet trial requirements.

• Create and assess clinical documents such as concept sheets/decks, clinical study protocols, investigator brochures, and regulatory materials.

• Organize and present data, study designs, and other relevant information to advisory boards, investigator meetings, site interactions, study committees, and various internal and external stakeholders.

⛳️ Requirements

• A PhD or equivalent with 5+ years of experience, or a bachelor’s/master’s degree with 10+ years of post-graduation experience in the pharmaceutical industry, specifically in clinical drug/biologics development and related regulatory processes.

• Strong organizational capabilities to ensure effective data collection and documentation for the analysis and interpretation of clinical trial outcomes.

• Proven ability to engage effectively with both internal team members and external partners.

• Experience in clinical data analysis.

• Capability to influence decision-making within a multidisciplinary team based on areas of expertise.

• Exceptional communication and presentation skills.

• Willingness to travel for business purposes, with up to 20% travel required.

• Preferably experienced in Phase I-III drug development trials, with a focus on product development in Hematology-Oncology and/or rare diseases.

🏝️ Benefits

• Competitive salary along with an annual bonus.

• Comprehensive benefits package that includes medical, dental, and vision insurance, a 401(k) retirement plan with company matching, and additional perks.

• Generous parental leave and family planning support.

• A vibrant company culture with opportunities for both personal and professional development.