- Character: Committed to always doing what's right.
- Audacity: Willing to challenge convention and share candid feedback with others.
- Determination: Curious and self-motivated. Always looking to improve and learn.
- Collaboration: "No job is too small" mentality. Humble and willing to help others.
- Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
- Develop and execute global clinical regulatory strategies.
- Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications.
- Oversee strategy and drafting of documents related to interactions with regulatory authority on clinical matters.
- Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine.
- Support internal clinical and development teams to provide direction on global regulations and guidance.
- BSc in natural or health sciences (biology, pharmaceutical sciences, or equivalent).
- 12-15+ years of clinical regulatory affairs experience, including early and late phase research, with strong knowledge of health authority regulations and guidance. Candidates with less experience may be considered at the director level.
- Proficiency directly writing submission documents that support clinical trials, marketing applications, and lifecycle management.
- Experience interacting with Health Authorities and reviewing materials to ensure compliance with applicable regulatory laws and guidance.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
- Exceptional project management skills, organizational and problem-solving skills.
- Eager to learn with a collaborative, team-oriented mindset.
- Excellent written and verbal communication skills.
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Senior Director, Clinical Regulatory Affairs - Redwood City, United States - Arcellx, Inc.
Description
Who We AreArcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
As our Senior Director, Clinical Regulatory Affairs, you'll lead and drive Arcellx's clinical regulatory approval strategy and implementation and oversee post-approval regulatory requirements. By cultivating productive relationships with regulatory authorities and cross-functional members of the Arcellx team, you'll play a critical and highly visible role in getting our transformative therapies to market.
The "Fine Print" - What You'll Do
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The base salary range for this position is $280,000 - $310,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to
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