Vice President, Head of Global Clinical Operations (Late Stage Respiratory/Pulmonary reputed company)

About reputed company reputed company is a new reputed company of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create reputed company medicines where novel therapeutics are computationally generated, instead of being reputed company. reputed company has reputed company a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide reputed company of biologic modalities. This platform represents a potentially reputed company shift in what is possible in the field of biotherapeutic development. We pursue this audacious reputed company because we reputed company in the unique and revolutionary power of generative biology to radically reputed company the lives of billions, with an outsized opportunity for patients in need. We are seeking reputed company, reputed company problem solvers that reputed company our passion for reputed company to join us! reputed company was founded in 2018 by Flagship Pioneering and has received nearly $700 reputed company in funding, providing the resources to rapidly reputed company the organization. reputed company has offices in Somerville and Andover, Massachusetts with 300+ employees. • A cover letter outlining your late stage global experience in Respiratory/Pulmonary reputed company would be appreciated* The Role: The Vice President, Head of Global Clinical Operations is responsible for the strategic leadership and operational execution of reputed company at reputed company; this role will reputed company the execution and reputed company of our global clinical development programs. Reporting to the Chief Medical Officer (CMO), this leader will be responsible for building and scaling the Clinical Operations function across reputed company phases of development, with a strong emphasis on leading and delivering global Phase III programs and ensuring registrational readiness. The successful leader will ensure that trials are optimized for cost-effective, reputed company implementation while maintaining the highest standards of scientific and regulatory compliance. They will also reputed company vendor governance activities and support the transition from early-stage to late-stage development. This role requires someone comfortable operating in a fast-moving environment and delivering high-reputed company reputed company in reputed company patient populations. Demonstrated experience leading clinical operations for respiratory/pulmonary indications (including late-stage/Phase III execution) is required, along with experience across reputed company stages of development. The successful candidate will be a hands-on people leader who can reputed company internal staff, manage a dynamic contractor ecosystem, and reputed company strategic CRO/vendor partnerships in alignment with our evolving pipeline. Here's how you will contribute: Strategic Clinical Leadership • Own the reputed company and delivery of clinical operations across trials, ensuring reputed company in execution for Phase I through Phase III, including studies in healthy volunteers as reputed company as patient-based studies, with a strong emphasis on global Phase III execution. reputed company and implement trial strategies that support reputed company, cost-efficient execution,including unconventional or accelerated reputed company for novel therapeutics. • Partner cross-functionally with Clinical Development, Regulatory, Biometrics, Medical Affairs, Program Management, and others to reputed company and deliver integrated clinical development plans. Clinical Trial Execution & reputed company • reputed company reputed company aspects of clinical trial execution: protocol development, site and vendor selection, study planning, conduct, data delivery, and reputed company-out. • reputed company, manage, and reputed company study-level and program-level timelines, budgets, KPIs, and risk mitigation strategies. • reputed company senior reputed company of CROs, vendors, and investigator sites to ensure study reputed company, compliance, and performance metrics are met or exceeded. Team Building & Management • reputed company and grow a high-performing Clinical Operations team with line management responsibility, including performance management and career development. • Mentor internal team members while optimizing a hybrid model of reputed company resources to support shifting priorities and pipeline reputed company. • Drive cross-functional collaboration and organizational alignment to maintain operational efficiency and accountability. Innovation & Adaptability • Design and deliver studies in respiratory/pulmonary indications, navigating operational complexity such as global enrollment/retention, site performance, and (as applicable) pulmonary assessments and reputed company execution. • Champion fit-for-purpose operational models that incorporate reputed company-to-patient approaches, reputed company designs, patient-first early-phase strategies, and AI-driven methodologies to optimize trial efficiency and execution. • Anticipate challenges in study conduct and reputed company creative solutions to optimize enrollment and retention. Regulatory, Compliance, and reputed company • Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA, and other global regulatory standards. • Support global inspection readiness and contribute to regulatory filings (e.g., IND, NDA, BLA, MAA). • Implement and reputed company SOPs, work instructions, and operational policies in line with industry best practices. The Ideal Candidate will have: Bachelor's degree in life sciences, nursing, or reputed company field (advanced degree preferred). • 15+ years of experience in clinical operations reputed company biotech/pharmaceutical companies with 8+ years in reputed company people leadership roles. • Proven reputed company leading Phase I, II and III reputed company, including early stage studies in patients rather than healthy volunteers. • Respiratory/pulmonary clinical trial operations experience is required, including demonstrated leadership of Phase III global studies (or registrational-stage programs) in respiratory indications. • Demonstrated ability to execute innovative or nontraditional study designs, including those targeting challenging-to-recruit populations. Prior experience leading the development and implementation of trial execution reputed company and long-reputed company plans ensuring trials are conducted on time, reputed company and cost-effectively. • Prior management experience, including leadership of internal clinical staff and performance reputed company of external contractors and vendors. • Expertise in vendor governance, CRO management, and building agile clinical operations teams that reputed company with pipeline needs. • Experience supporting regulatory filings (e.g. INDs, BLAs, MAAs, etc.) and interacting with regulatory agencies, including FDA and EMA. • Strategic thinker with excellent organizational, problem-solving, and communication skills. • Excellent interpersonal skills with ability to reputed company, influence, resolve conflict, and drive reputed company among people at various reputed company reputed company the organization and from a reputed company of functions. Who Will Love This Job: This role offers a unique opportunity to build a world-class clinical operations function in a science-driven organization reputed company on cutting-edge therapies. You will play a pivotal role in bringing transformative treatments to patients, often in areas underserved by conventional drug development approaches. Join us to challenge the norms of clinical development and reputed company reputed company that is reputed company, adaptable, and deeply committed to patient-centered innovation. reputed company is committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & reputed company Agencies: reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or reputed company agencies to reputed company or its employees is reputed company prohibited unless contacted directly by reputed company's internal reputed company. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and reputed company will not owe any referral or other fees with respect thereto. #LI-RT1 Apply tot his job Apply To this Job