Contract Sr. Clinical Scientist

Job title: Contract Sr. Clinical Scientist

About the Role

The Contract Sr. Clinical Scientist applies drug development and regulatory expertise to execute pivotal responsibilities in a collaborative clinical development setting. This on-site role in Cambridge, MA supports early- and late-stage assets in CNS, Rare Disease or Cardio-metabolism and ensures compliance with GCP/ICH and regulatory requirements.

What You'll Do

• Contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments.

• Maintain proficient understanding of therapeutic disease areas and drug candidate biology, mechanism of action, and competitive landscape; ensure compliance with FDA, EMEA, ICH, GCP and applicable SOPs.

• Propose, design, and execute clinical research and development studies for early and/or late-stage assets; communicate strategies grounded in supporting literature.

• Collaborate with medical writing to author clinically relevant sections and review trial protocols/amendments.

• Author/review documents such as medical monitoring plans, SAPs, informed consents, and Clinical Study Reports components; support regulatory document development and perform quality reviews.

• Lead planning/preparation for external/stakeholder meetings (IM, Governance, DMCs, Regulatory); present data to external investigators (SIV) and internal stakeholders.

• Perform clinical/medical data review and safety monitoring; implement activities to ensure patient safety.

• Apply analytical skills to understand how program objectives affect data analysis; identify risks and implement mitigation.

• Promote consistent first-line medical/clinical data review techniques; review data review plan and medical monitoring plan for assigned studies.

• What We're Looking For

• Bachelor’s degree or advanced degree (PhD/MD/PharmD/MSc) in life sciences/healthcare; 10 years pharma clinical drug development experience preferred.

• Experience in CNS, Rare Disease, or Cardio-metabolism preferred; solid knowledge of GCP/ICH regulatory requirements.

• Ability to manage multiple priorities with strong planning, time management, and prioritization.

• Strong analytical skills to interpret clinical trial data and synthesize conclusions.

• Proficiency in proposing/designing clinical research and authorship of trial documents (monitors/SAPs/ICF/Clinical Study Reports).

• Excellent cross-functional collaboration with Clinical Development stakeholders; problem solving, conflict resolution, and critical thinking.

• Strong communication, technical writing, and presentation skills.

• Nice to Have

• Advanced degree (PhD/MD/PharmD/MSc) preferred; experience with regulatory documents such as medical monitoring plans and SAPs is advantageous.

• Compensation & Benefits

• Salary: 98-108 USD per hour, based on experience.

• Equal Opportunity Employer; commitment to diversity, inclusion, and respectful work environment.