Apex Systems Looking for Associate Director, Clinical Scientist at Newton, MA Full Time

Associate Director, Clinical Scientist 1255962

Job Scope & Purpose:

Our long-term client, a clinical stage biopharmaceutical company focused on fibrotic kidney and lung diseases, is seeking an experienced Clinical Scientist to join an impressive team. This individual will provide scientific, clinical, and operational input to early and late-stage clinical development programs. They will collaborate with study teams to design, execute, and monitor clinical trials. This role will serve as a point of contact for CROs and investigators in day-to-day clinical study needs. This individual will report into the Vice President, Clinical Operations and can work remotely (preference is EST).

Primary Job Responsibilities:

• Work with cross-functional team to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, slide decks for clinical trials outcomes and results, communication, safety and medical monitoring, preparation of status update reports, and study close-out activities.
• Support Medical Lead with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs.
• Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety.
• Provide clinical operational support to Pharmacovigilance, Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
• Interact with internal and external stakeholders in support of clinical trial objectives.
• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
• Support preparation of scientific material for conference presentations or publications.

Primary Job Requirements:

• Life sciences degree (Advanced degree preferred)
• 2-6 years of clinical research experience in the pharmaceutical or biotech industry
• Experience working with clinical trial sites
• Experience with global clinical research
• Strong writing experience (specifically clinical documents)
• Experience in all phases of drug development
• Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, Google Cloud Platform, and regulatory requirements for clinical studies.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

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.

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 or .