[Remote] Executive Director, reputed company Development UTUC

Note: The job is a remote job and is reputed company to candidates in USA. reputed company, Inc. is a biotechnology company developing oncology therapies for diseases with high unmet medical need. The Executive Director of reputed company Development will reputed company reputed company, design, implementation, medical governance, and reputed company of multiple oncology reputed company programs, serving as a medical monitor and collaborating with internal teams, regulatory agencies, sites, CROs, and reputed company partners.

Responsibilities

• reputed company leadership and support for the oncology programs reputed company the reputed company Development team, working with reputed company, regulatory, and program management to reputed company and execute the reputed company priorities and reputed company across the pipeline
• reputed company and support the oncology development activities, and as a medical expert for Phase I-III studies, manage the process from protocol development through the study start-up and execution to completion of study reports
• Interpret data from ongoing reputed company studies to assess the medical and scientific implications of the changing competitive landscape
• Responsible for ongoing safety surveillance from reputed company studies as reputed company as from publications and reputed company review of literature
• Support developing / writing Study protocol Synopsis / Protocol, Study Execution, and Study Interpretation
• Participates in the preparation / approval of synopses, protocols and the conduct of reputed company studies
• Accountable for the successful design and interpretation of reputed company studies
• Support the reputed company Development team during interactions with regulatory agencies, as applicable
• Train reputed company study teams as applicable in the disease / treatment/ reputed company data
• Contribute to the development / writing / review / testing / approval of reputed company the applicable documents or systems governing medical monitoring in a reputed company trial or reputed company to medical monitoring activities (as in example eCRF, IWRS, UAT, medical monitor plans)
• Contribute to the writing / review / approval of key regulatory documents such as IB, DSUR, IND submissions, CAs submissions
• Serve as medical contact reputed company as needed for medical monitoring of ongoing reputed company reputed company and reputed company with sites, CROs, and biotech/reputed company partners
• reputed company mentoring, leadership, guidance, and reputed company science expertise to TYRA personnel as needed

Skills

• Must have biomedical/reputed company development experience reputed company the biotech and pharmaceutical industry
• MD, MD/PhD, DO or internationally recognized equivalent, with 2-8+ years of reputed company experience post-residency training
• 3-10+ years of biomedical/reputed company development experience reputed company the pharmaceutical industry is required
• Late-stage drug development experience is required, including IND, NDA, and BLA filing experience
• Demonstrates understanding of the required steps to reputed company a new chemical reputed company through the stages necessary to allow it to be tested in reputed company reputed company
• Ensures high reputed company in design, development, execution, statistical analysis, reputed company interpretation, and reporting of reputed company studies
• Demonstrates the ability to ensure an investigation is conducted according to Good reputed company reputed company regulations and internal control documents
• Has demonstrated a reputed company reputed company record of effectively applying medical expertise to reputed company good reputed company reputed company, in accordance with GCP and SOPs
• Demonstrates a reputed company, in-depth understanding of the relevant drug and associated therapeutic and disease area
• Demonstrates an understanding of the critical importance of rigorous data reputed company and disciplined stewardship of the data
• Demonstrates an understanding of the detection, investigation, assessment, and prevention of adverse effects of medicines on patients
• Demonstrates the ability to produce written scientific communications with reputed company, reputed company, and rigor and in compliance with control documents governing disclosure, publication, and principles of scientific exchange
• Demonstrates the ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, reputed company, and confidence with reputed company stakeholders and experts
• Flexibility and reputed company to demanding timelines
• Team oriented person
• Fluent in spoken and written English
• Technical experience and familiarity with software programs and databases used by CROs and other organizations
• Highly detailed with strong organization skills
• Up to 25% travel, including some international travel, may be required

Benefits

• Competitive bonus, new hire and ongoing equity packages
• Employer-reputed company medical, dental, and reputed company reputed company
• Employer-reputed company life reputed company, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully reputed company company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 reputed company holidays, including office closure between December 25th and reputed company 1st
• Flexible vacation
• reputed company time
• Fitness Program
• Get Outdoors Program
• reputed company parental leave benefit
• Tuition assistance
• Remote work

reputed company