Note: The job is a remote job and is open to candidates in USA. Tyra Biosciences, Inc. is a biotechnology company developing oncology therapies for diseases with high unmet medical need. The Executive Director of Clinical Development will lead strategy, design, implementation, medical governance, and oversight of multiple oncology clinical programs, serving as a medical monitor and collaborating with internal teams, regulatory agencies, sites, CROs, and external partners.
Responsibilities
- Provide leadership and support for the oncology programs within the Clinical Development team, working with operations, regulatory, and program management to develop and execute the clinical priorities and strategy across the pipeline
- Lead 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 internal and external studies to assess the medical and scientific implications of the changing competitive landscape
- Responsible for ongoing safety surveillance from internal and external studies as well as from publications and systematic 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 clinical studies
- Accountable for the successful design and interpretation of clinical studies
- Support the Clinical Development team during interactions with regulatory agencies, as applicable
- Train internal and external study teams as applicable in the disease / treatment/ clinical data
- Contribute to the development / writing / review / testing / approval of all the applicable documents or systems governing medical monitoring in a clinical trial or related 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 point as needed for medical monitoring of ongoing alliance projects and interface with sites, CROs, and biotech/pharma partners
- Provide mentoring, leadership, guidance, and clinical science expertise to TYRA personnel as needed
Skills
- Must have biomedical/clinical development experience within the biotech and pharmaceutical industry
- MD, MD/PhD, DO or internationally recognized equivalent, with 2-8+ years of clinical experience post-residency training
- 3-10+ years of biomedical/clinical development experience within 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 progress a new chemical lead through the stages necessary to allow it to be tested in human clinical trials
- Ensures high quality in design, development, execution, statistical analysis, clinical interpretation, and reporting of clinical studies
- Demonstrates the ability to ensure an investigation is conducted according to Good Clinical Practice regulations and internal control documents
- Has demonstrated a proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with GCP and SOPs
- Demonstrates a current, in-depth understanding of the relevant drug and associated therapeutic and disease area
- Demonstrates an understanding of the critical importance of rigorous data generation 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 clarity, accuracy, 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, accuracy, and confidence with internal and external stakeholders and experts
- Flexibility and adaptation 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-paid medical, dental, and vision insurance
- Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
- Employee Stock Purchase Plan
- 14 -18 paid holidays, including office closure between December 25th and January 1st
- Flexible vacation
- Sick time
- Fitness Program
- Get Outdoors Program
- Paid parental leave benefit
- Tuition assistance
- Remote work
Company Overview