In this position, you’ll be part of an energizing and supportive startup team culture, engaged in continuous learning, and collaborating with an exceptional international team. This role is located at our site in Boston’s Seaport district.
In this role, your responsibilities & contributions will include :
Clinical Development & Strategy :
- Protocol Development : Lead the development and amendment of protocols, informed consent forms (ICFs), and related documents with minimal guidance, ensuring cross-functional input and alignment.
- Innovative Trial Designs : Evaluate and recommend novel trial designs in collaboration with the Head of Development.
- Scientific Expertise : Serve as a subject matter expert, providing knowledge and insights to shape clinical strategies and trial plans.
- Regulatory Support : Draft and contribute to regulatory submissions (e.g., INDs, CTAs), serving as a hands-on partner in addressing regulatory agency queries.
Trial Implementation, Execution, & Oversight :
Startup to Close-Out : Plan and oversee clinical study startup, conduct, and close-out activities to ensure timely execution.Data Monitoring : Lead activities related to data generation, validation, and review, including CRF design, clinical data review, query resolution, and trend identification.Site Training & Oversight : Develop and deliver training materials for site initiation visits (SIV) and investigator meetings. Act as the primary point of contact for site-facing activities, including addressing clinical questions and managing relationships with vendors / CROs.Safety Oversight & Governance : Lead safety review activities, including dose escalation studies and adverse event analyses, working closely with drug safety, and providing updates to governance committees.Cross-Functional Collaboration & Leadership :
Integrated Execution : Collaborate closely with cross-functional teams, including Translational Science, Clinical Operations, and Integrated Business Planning (IBP), to ensure seamless execution of clinical programs.Stakeholder Engagement : Build strong relationships with internal and external stakeholders, including key opinion leaders (KOLs), study investigators, and vendors, while providing regular updates on trial progress to ensure transparency and alignment.Problem Solving : Address clinical and operational challenges head-on, proposing and implementing real-time solutions.Processes & Infrastructure :
Operational Foundations & Management : Develop and implement streamlined processes for trial execution, safety monitoring, and data review, ensuring scalability as the portfolio grows.Metrics & Reporting : Establish templates and best practices for clinical documentation and track trial progress, ensuring consistency and compliance with GCP and ICH guidelines.Budgeting & Planning : Collaborate with protocol managers to develop trial budgets, CRO scopes of work, and resource planning.Knowledge Sharing :
Publication & Communication : Author and review abstracts, presentations, and manuscripts to share study findings and insights with the broader scientific community.Mentorship : Provide guidance to junior team members, fostering a culture of continuous learning and developmentInternal Learning : Create and deliver internal presentations to align cross-functional teams on clinical progress, challenges, and strategic adjustments.To thrive in this role, you’ll need...
Medical Degree (MD) or equivalent requiredAt least 5 years of experience in clinical development, with at least 2 years of hands-on operational involvement in Phase I-III trials.Proven ability to lead trial design and execution end-to-end, including protocol development, site oversight, and safety monitoring.Familiarity with regulatory submission processes and agency interactions (FDA, EMA, etc.).A proactive, hands-on mindset to meet daily challenges with confidence, professionalism, and resilience in a fast-paced startup setting with shifting priorities.Exceptional verbal and written communication skills, with the ability to collaborate effectively across diverse functions and organizational levels.Experience reviewing clinical data, identifying trends, and applying insights to refine trial designs.Strong critical thinking and problem-solving skills, with the ability to anticipate challenges and implement effective solutions.Proficient knowledge of disease areas, KOLs, indications, and compounds under study (including MOA, PK / PD, biomarker, and safety profiles).A background in oncologyIt would be nice but not required to have…
Experience in first in human studies and adaptive trial designs.Board certification in a relevant specialty.J-18808-Ljbffr
