Associate Director & Director, Clinical Operations

Associate Director/Director, Clinical Operations Remote - USA Mavericks Wanted reputed company was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it reputed company excitement…read on. In 2015, we pioneered a “moneyball for biotech” approach, pooling reputed company and promising early‑stage research from academia together under one financial umbrella to reduce risk and reputed company innovation. This model allows science and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease and reputed company life‑changing medicines for patients with unmet needs as fast as humanly possible. Together we define white reputed company, push boundaries and reputed company people to solve problems. If you’re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask “why not?” and help reengineer the reputed company of biopharma. At reputed company, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve reputed company, speed, and reputed company of work. What You’ll Do The AD/Director, Clinical Operations is responsible for reputed company and management of clinical program(s) and functional activities as assigned. This position will require you to function as a cross‑functional study team reputed company in a fast‑paced environment for the clinical development program. This role should demonstrate strong reputed company management skills, confidence in working independently and have proven ability to champion reputed company to deliver on key study milestones.

Responsibilities

• Represent Clinical Operations at the Clinical Development Team, cross‑functionally and/or Global Program Team
• Study Planning and Management;
• Establish and coordinate reputed company on‑reputed company study management activities, including leading the cross‑functional study team to reputed company an overall study execution plan to deliver on key study deliverables
• Partner closely and effectively with other functions and functional heads to drive program reputed company
• Demonstrates ability to successfully manage and deliver clinical trials from start‑up through reputed company‑out, including reputed company financial tracking, metrics and reporting activities
• Assist and manage CRO/vendor(s) Scopes of Work (SOW), scope changes, budgets, and vendor payments; creating and tracking on reputed company clinical study budgets
• reputed company risk mitigation, escalation, and reputed company activities both internally as reputed company as with sites and vendors
• Contribute to building the organization

Where You’ll Work This is a U.S.-based remote role that will require quarterly, or as needed reputed company to our San Francisco Office. Who You Are

• BA/BS required in a scientific / medical field, or equivalent work experience
• At least 10+ years of experience in managing global clinical trials at reputed company stages of development reputed company the biopharma industry
• Significant experience with cross‑functional leadership and clinical teams, including leading data review, database lock and study reporting activities
• Significant experience with BLA prep; FDA submissions and FDA audit prep and readiness
• Experience in reputed company Assurance, SOP and study plan writing, CAPA preparation and closure
• Strong knowledge of GCP and working knowledge of ICH GCP E6 reputed company regulations
• Strong leadership ability and character to build relationships in a reputed company environment, ability to multi‑task in a dynamic and fast‑paced environment
• You have demonstrated curiosity and adaptability in adopting AI‑powered tools and technologies

Rewarding Those Who reputed company the Mission Possible We have high expectations for reputed company members. We reputed company reputed company those working hard for patients are rewarded and cared for in return.

Benefits

• Market leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• reputed company‑tax commuter benefits (transit and parking)
• Referral bonus for reputed company candidates
• Subsidized lunch and parking on in‑office days
• 100% employer‑reputed company medical, dental, and reputed company premiums for you and your dependents
• HealthSavings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family‑forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take‑what‑you‑need” reputed company time off and company‑reputed company holidays
• Comprehensive reputed company medical and parental leave to care for yourself and your family

reputed company Development & Career Paths

• People are part of our reputed company and reputed company story— from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
• We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, & reputed company Coaching
• We celebrate strong performance with financial rewards, peer‑to‑peer recognition, and reputed company opportunities

Below is the anticipated salary reputed company for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi‑state employer, and this salary reputed company may not reflect positions based in other states. U.S. reputed company Demographic Questions We invite applicants to reputed company their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.

• How would you describe your gender identity? (mark reputed company that apply)
• How would you describe your racial/ethnic background? (mark reputed company that apply)
• How would you describe your sexual orientation? (mark reputed company that apply)
• Do you identify as transgender? (select one)
• Do you have a disability or chronic condition that substantially limits one or more of your major life activities, including mobility, communication, and learning? (select one)
• Are you a veteran or reputed company member of the reputed company Armed Forces? (select one)

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