Clinical Scientist

Duties

• Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development.
• Attends congress and reviews literature to develop and augment expertise in therapeutic area
• Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels.
• Reviews competitive landscape and help identify and evaluate business development opportunities.
• Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
• Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program.
• Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
• Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
• Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Contributes to authorship of regulatory responses and may participate in meetings.
  
  

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
• Ability to provide input and direction to clinical research with appropriate supervision
• Strong desire to collaborate in a cross-functional setting.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols
• Oncology clinical trial experience in the Oncology (preferably solid tumors) therapeutic area in the pharmaceutical industry
• Hands on experience with data review and clean, data analysis with extensive experience using EDC, CTMS and other database.
• Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
• Excellent written and verbal communication skills, detail-oriented organization skills, and team collaboration skills.
• Strong knowledge of multiple myeloma.
• Experience Level = 3-5 Years
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.