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DATE ADDED: Wed 22/01/2020

Clinical Scientist - Hematology/Oncology

Waltham, MA, US
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COMPANY: APEX SYSTEMS, INC

JOB TYPE: Permanent, FullTime

Job Description Job : 1032230 Clinical Scientist, Hematology/Oncology1032230 Job Scope & Purpose: Our established and long-term client is seeking a qualified and talented Clinical Scientist to serve a key role in drug development of the company's 3 programs. The successful candidate will contribute to the trial development strategy assisting with protocol development and study design and clinical study execution. The position will report to the Executive Director, Clinical Research and Development. The Clinical Scientist is responsible for reviewing and interpreting patient and study data and ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies. Primary Job Responsibilities: Interface internally and externally as the clinical science lead in support of a given study or program. Provide clinical oversight of the study execution in collaboration with all members of the clinical study team. Participate in site visits as needed. Review and monitor emerging safety and efficacy clinical data and develop sound, strategic solutions to study and program issues and collaborates with the clinical team to ensure issue resolution. Support the MD leader with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals. In collaboration with biostatistics, clinical pharmacology, clinical operations, and data management, contributes to the development of the plan to execute on trial design. Collaborate with the clinical development team on the review, analysis, and interpretation of individual patient data and study results, ensuring appropriate medical data review and accurate data reporting. Develop presentations and communicate study data results to colleagues internally and to external audiences, including investigators at sponsor meetings or general audiences at scientific conferences. Primary Job Requirements: RN, NP, MS, Ph.D. or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred. Strong analytical scientific background with at least 5 years of industry clinical development experience in oncology required. Experience working with an external CRO is desirable. Candidates must possess effective communication and influencing skills. Has a general understanding of project management tools. Ability to seek and understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy. Ability to interpret, analyze, and present clinical data to inform decision-making and set clinical strategy. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. jpricestratacuity.com Code: ClinOps EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178. - provided by Dice
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