Tyra Biosciences, Inc. is seeking a highly qualified Executive Director/VP of Clinical Development to lead and support strategy, design, and implementation of the skeletal dysplasia drug development programs targeting disease areas with high unmet medical need.
This person will collaborate with key internal and external stakeholders to support the Skeletal Dysplasia teams, leading multiple clinical programs, functioning as medical monitor for several clinical studies, contributing scientific knowledge and expertise. The successful candidate will be highly organized, self-motivated, and thrive in a small, dynamic, cross-functional environment.
This position will be heavily focused on medical governance and oversight of Tyra sponsored clinical programs.
Must have biomedical/clinical development experience within the pharmaceutical industry.
Essential Functions and Responsibilities
- Provide leadership and support for the skeletal dysplasia 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 drive the skeletal dysplasia development activities, and as a senior 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.
- Leader in developing / writing Study protocol Synopsis / Protocol, Study Execution, and Study Interpretation.
- Key contributor in the preparation / approval of synopses, protocols and the conduct of clinical studies.
- Accountable for the successful design and interpretation of clinical studies.
- Key contributor to 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.
- Leader in 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).
- Key contributor for 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.
Education & Experience
- MD, MD/PhD, DO or internationally recognized equivalent, with 10+ years of clinical experience post-residency training.
- 15+ years of biomedical/clinical development experience within the pharmaceutical industry is required. Prior IND, NDA, and BLA filing experience is required.
- Late-stage drug development experience on multiple trials (P3) required, through commercialization preferred.
- 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, in order to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data. Ensures the study is in a continuous state of inspection readiness.
- Has demonstrated a proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with GCP and SOPs.
- Extensive expertise and 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. Knows when to involve the Safety Development Leader for escalation eg, to the Chief Medical Officer, study, or program safety committee(s), etc.
- High competence in producing written scientific communications with clarity, accuracy, and rigor and in compliance with control documents governing disclosure, publication, and principles of scientific exchange.
- Strong communication skills, including formal presentations and informal scientific discussions, 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.
Pay Range and Benefits
Base Salary Range: $358,542 - $394,967 USD
Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.
What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- The starting compensation range(s) for this role is for a full-time employee (FTE) basis
- Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
- 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
Job Type: Full-Time
Work authorization: United States (Required)
Work Location: Remote
Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
