Clinical Research Physician (5-7 years)

　　Location: Remote, reporting to Cambridge MA

　　Duration: Contract 12 months

　　Shift: Monday-Friday 9am-11am (10 hours per week)

　　Pay: $267/hour

　　Haves:

　　Medical Doctor, Oncologist/Hematologist, Medically qualified.

　　Must have pharmaceutical industry experience.

　　•MD or DO degree with experience in Medical oversight of clinical trials. At least 5-year industry experience in drug development.

　　Must have served as a medical monitor and/or safety physician on an oncology trial in the past.

　　Responsibilities:

　　Serve as a general study physician and safety physician for ongoing and planned clinical studies from Phases 1-2.

　　Participating in study planning (e. g. , sample size, patient commitment, timelines, and grants).

　　Protocol authoring.

　　Risk assessment of molecule.

　　Scientific oversight and management of clinical development strategy for assigned assets at Chorus

　　Review and approve protocols, risk profiles, ICDs, clinical study reports, and disclosure of research results

　　Provide oversight and assistance in managing medical questions from investigator sites, including dose-escalation decisions, adverse events, and trial-level safety review

　　Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions

　　Conduct due diligence on compounds that are potentially entering Chorus portfolio to assess feasibility and fit

　　Manage safety for Chorus compounds and clinical trials as per delegation agreement with Global Patient Safety

　　Manage and responsible for first-in-human dosing and dosing escalation decisions for Chorus protocols and ensure communication with Chorus leadership and appropriate Lilly responsible manager(s) are in alignment of the plan

　　Ensure contracts with CROs are consistent with medical and safety requirements and review safety management plans for clinical studies

　　Work with regulatory personnel to ensure compliance

　　Serve as Sponsor physician for case-management of SAEs

　　Help assure completion of administrative requirements for study initiation and conduct (i. e. , ethical reviewboard, informed consent, regulatory approval/notification) consistent with GCP and local requirements. P

　　Planning of and participation in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.

　　Being available to Clinical Research Associates (CRA) to address any questions or clarify issues arisingduring the conduct of study.

　　Monitor patient safety during conduct of studies.

　　Ensure appropriate communication of risks to subjects.

　　Help assure initiation of appropriate pharmacovigilance actions if necessary in collaboration with appropriate program/product team physicians, investigators, ethical review boards, and regulatory scientists. Participation in data analysis, developing the scientific disclosure strategy, and preparation of final reports and publications.

　　Assisting program/product team in preparation of regulatory reports, including NDAs and annual reports to the FDA, and in preparation for FDA advisory committee hearings and label negotiations, providing support for local registration, development of local labeling, and communication and resolution of regulatory issues from an affiliate perspective.

　　Commercialization Trial Support for Marketed Products.

　　Working with clinical research staff in the design and conduct of local commercialization support studies.

　　Working closely with CRAs, statisticians, and investigators in development of protocols and CRFs.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.