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🧬 Job Title: Clinical Scientist II Location: Strong preference Waltham, MA 02451 – to enable partnership with the TA MD. If Hybrid, must be tied to Hub – Chicago (2nd preference) or South San Francisco (3rd preference) Assignment Length: 6 months (Possible Extension) Experience Level: 3–5 Years Therapeutic Area: Oncology – specifically ovarian cancer (drug: Elahere) 📌 Role Overview: The Clinical Scientist II will contribute to the review, interpretation, and communication of scientific data related to the efficacy and safety of compounds in development. This role focuses on Phase 3 oncology studies with a strong emphasis on data review, cleaning, and management. The position collaborates cross-functionally to support regulatory, commercial, and medical education strategies. 🔬 Key Responsibilities • Contribute to scientific data review and interpretation to support compound development. Attend congresses and review literature to enhance therapeutic area expertise. • Develop program strategy, including clinical development plans, product lifecycle plans, target product profiles, and draft labels. Review competitive landscape and support evaluation of business development opportunities. • Provide clinical study support, from study start-up through Clinical Study Report (CSR) preparation. • Participate in scientific education of internal and external stakeholders on pre-clinical (e.g., mechanism of action, animal models) and clinical data (e.g., epidemiology, diagnosis, treatment). Engage opinion leaders to build pipeline awareness and foster collaborations. • Contribute to scientific content development of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents. • Support database and study systems, including electronic data capture (EDC), IRT, and training documents, ensuring data completeness and fidelity throughout study conduct. • Collaborate cross-functionally to create a scientific platform supporting regulatory, commercial, and medical education strategy for late-stage assets. • Ensure adherence to Good Clinical Practices (GCP), pharmacovigilance standards, standard operating procedures, and all other quality standards. Contribute to regulatory responses and participate in meetings as needed. 🎓 Qualifications • Bachelor’s degree in the sciences required; advanced degree (PhD, MS, PharmD) preferred. • Ability to provide input and direction to clinical research under appropriate supervision. • Clinical trial experience in the pharmaceutical industry, academia, or equivalent. • Knowledge of clinical trial methodology, regulatory, and compliance requirements for clinical studies. • Strong desire to collaborate in a cross-functional setting. ⭐ Top 5 Required Skills • Oncology clinical trial experience, preferably solid tumors, in the pharmaceutical industry. • Hands-on experience with data review, cleaning, and analysis, using EDC, CTMS, and related databases. • Scientific content development: Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents. • Excellent written and verbal communication skills, with strong attention to detail, organization, and team collaboration. • Ability to support Phase 3 study conduct, data assessment, query integration, clarifying variables with sites, and overall clinical data review. 📍 Additional Role Details • Focused on Phase 3 oncology study work with heavy involvement in data management and clinical data review. • No travel required; role is not site-facing. • Team support: Work within a team of 6. • Onsite preference: Boston/Waltham (former ImmunoGen office), schedule Tues–Thurs in office. • If onsite not possible, role can be based at hubs (Chicago or South San Francisco). • Advanced degree preferred (PharmD, PhD, MS). ✅ Key Keywords Highlighted: Clinical Scientist II, Oncology, Phase 3, Data Review, Data Cleaning, EDC, CTMS, Protocols, IBs, CSRs, ICFs, Regulatory Documents, GCP, Collaboration