AD/Director Clinical Operations (Study Lead)

The AD-Director, Clinical Operations is responsible for leading and managing all trial activities globally as the Study Lead, ensuring high standards of execution and compliance with local and global regulatory requirements. This role provides both strategic guidance and ensures executional delivery for Clinical Operations activities related to this program and is accountable for the delivery of this clinical development program. This role manages relationships with key external partners, including CROs, vendors, PI’s and other entities, ensuring alignment in a matrix team environment.Key Job Responsibilities:Oversee all clinical trial activities for the clinical program, ensuring operational excellence and timely execution.Provide strategic oversight and guidance for the clinical program, working closely with leaders across the Study Teams.Present clinical operation strategy and program status updates as needed for study teams as well as in Executive meetings.Setting strategy for program delivery including recruitment and program-level conduct that aligns with Corporate goals and strategies.Lead all aspects of study progress from planning to close-out in accordance with ICH-GCP guidelines, local regulations, patient safety standards and compliance with internal Standard Operating Procedures (SOPs).Facilitate problem-solving and conflict resolution with internal and external stakeholders to reduce issues / remove roadblocks and keep teams on track with key deliverables.Collaborate with the appropriate functions ensuring the resourcing, budgeting and the internal and outsourcing strategies align across programs and/or clinical trials.Establish goals and oversee vendor performance metrics, managing any issues or escalations as needed.Provide support and oversight to staff for development and optimization of global clinical strategy and processes, including effective delegation to direct reports to meet program goals.Proactively work with cross-functional teams to develop and implement study plans.Accountable for ensuring accurate and up-to-date study and program information within relevant tracking systems and providing regular updates; proactively identify, risk-manage, and resolve issues that arise during study and program conduct; manage escalation of study and program-related issues.Oversee the development of budgets and timelines for program(s). Work with study team(s) to ensure accurate forecasting, tracking, and timely review of study budgets. Facilitate timely escalation of variances within established processes.Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO, and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Work very closely with study investigators to ensure timely and high-quality execution of clinical studies.Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, close-out plans, inspection readiness plans, CSRs, and other needed activities.Translate corporate and department goals into relevant, tangible, and measurable objectives for the operations team.Manage, lead and coach a high performing Study Program team. Drive and manage their individual and collective performance.Serve as a role model within and outside of Clinical Operations in problem identification, cross functional collaboration and implementation of planned resolutions.Provide leadership and oversight for audits, inspections, quality events, and CAPAs across clinical programs. Partner with Quality to ensure inspection readiness, timely responses, and effective CAPA execution.Drive continuous process improvement and quality risk management within Clinical Operations.Education & Experience RequiredThe position requires a bachelor’s or equivalent degree with 8+ years of progressive experience in Clinical Operations, with 5+ years of experience leading strategic areas of Clinical Operations and teams.6+ years of experience leading clinical trial design, execution and management with growing scope of responsibility throughout. Full cycle drug development experience through commercialization preferred.Thorough understanding and experience in the execution of global clinical trials, managing phase 1-III from initiation to BLA, with a diverse range of patient populations and therapeutic areas.Extensive knowledge of Clinical Research, including FDA and international regulations, ICH-GCPs, clinical trial design and documentation, and conduct of clinical trials.Experience with regulatory filings (e.g., NDA, BLA, MAA).Previous involvement in the oversight and management of GCP regulatory inspections.Excellent knowledge of ICH-GCP.3+ years direct supervisory responsibilities over program team members and ability to direct resources appropriately.Demonstrated leadership and management, both behavioral and technical skills with demonstrable growth.The ability to develop and administer budgets, schedules and create strategies to meet performance requirements or company objectives.Ability to provide technical advice and assist with problem resolution. Must be flexible and able to change direction quickly.Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research, vendors, contractors and administrative personnel.Comfort with presenting and interacting at the executive and Board levels.Experience in developing effective relationships with key investigators, key external experts, advocates, and vendors.Proficient in MS Outlook/Word/Excel/PowerPoint.Must be able to travel (domestic and international) up to 20%.Pay Range and BenefitsBase Salary Range: $227,254 - $241,441 USDIndividual 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 packagesThe starting compensation range(s) for this role is for a full-time employee (FTE) basisBenefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollmentEmployer-paid Medical, dental, and vision insuranceEmployer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage401(k) Plan with a fully vested company match 1:1 up to 4% of contributionsEmployee Stock Purchase Plan14 -18 paid holidays, including office closure between December 25th and January 1stFlexible vacationSick timeFitness ProgramGet Outdoors ProgramPaid parental leave benefitTuition assistanceJob Type: Full-TimeWork authorization: United States (Required)Work Location: RemoteEqual 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.