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Fda Openings Jobs in Bothell, WA (NOW HIRING)

Albertsons

Production Supervisor - Milk

Bellevue, WA

$85K - $95K/yr

Safeway is excited to announce an opening for a  Production Supervisor based out of our milk ... Ensure regulatory compliance as appropriate (OSHA, EPA, FDA, USDA, HACCP, Etc.) * Responsible for ...

Gold's Gym

Front Desk Associate

Kirkland, WA · On-site

$17.13/hr

Follow proper opening and closing procedures as instructed in the FDA training manual. * Logs all maintenance concerns that are reported. * Follows and reports any safety concerns. * Notifies ...

Gold's Gym Washington

Front Desk Associate

Kirkland, WA · On-site

$17.13/hr

Follow proper opening and closing procedures as instructed in the FDA training manual. * Logs all maintenance concerns that are reported. * Follows and reports any safety concerns. * Notifies ...

Variant Bio

Senior Security Engineer

Seattle, WA

$184K - $253K/yr

Background securing systems in a clinical, healthcare, or FDA-regulated environment. * Familiarity ... Contributions to the security or privacy community (research, open source, presentations)

Gold's Gym

Front Desk Associate

Woodinville, WA · On-site

$17.13/hr

Follow proper opening and closing procedures as instructed in the FDA training manual. * Logs all maintenance concerns that are reported. * Follows and reports any safety concerns. * Notifies ...

Gold's Gym

Front Desk Associate

Woodinville, WA · On-site

$17.13/hr

Follow proper opening and closing procedures as instructed in the FDA training manual. * Logs all maintenance concerns that are reported. * Follows and reports any safety concerns. * Notifies ...

Gold's Gym Washington

Front Desk

Woodinville, WA · On-site

$17.13/hr

Follow proper opening and closing procedures as instructed in the FDA training manual. * Logs all maintenance concerns that are reported. * Follows and reports any safety concerns. * Notifies ...

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What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
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Fda Openings jobs near you

Vice President, Clinical Development

Umoja Biopharma

Seattle, WA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 6 days ago

Job description

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma - Your Body. Your Hope. Your Cure.
POSITION SUMMARY
The Vice President, Clinical Development is a strategic and operational leader responsible for advancing the company's clinical-stage pipeline through all phases of clinical development. This role provides leadership and oversight for the Clinical Development organization, including Medical Directors and Clinical Scientists. The VP will lead the development and execution of integrated clinical development strategies, ensuring high-quality, compliant, and efficient clinical programs that support regulatory approvals and commercialization objectives.
As a key member of the Clinical Development Leadership Team, this role collaborates closely with Regulatory Affairs, Translational Medicine, Research, CMC, Quality, Commercial, and Executive Leadership to drive clinical and corporate objectives.
This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote on the West Coast for the right candidate with the expectation to be in Seattle 5 business days per month.
CORE ACCOUNTABILITIES:Specific responsibilities include:
  • Lead the overall clinical development strategy for the company's portfolio, ensuring alignment with corporate and regulatory objectives.
  • Partner with the CMO and Executive Leadership team to define development pathways, clinical endpoints, and regulatory strategies.
  • Build and develop a high-performing, scalable clinical organization of Medical Directors and Clinical Scientists. Establish clear goals, metrics and development plans for team members and leaders in alignment with Umoja's values and principles.
  • In collaboration with the CMO, communicate the clinical vision and emerging data to the Board, investors and potential partners, helping articulate the value, differentiation and development potential of Umoja's pipeline.
  • Shape the long-term clinical development strategy translating emerging clinical, translational and competitive insights into indication selection, sequencing and investment recommendations.
  • Define the clinical path for establishing in vivo CAR-T as a new therapeutic modality, including evidence generation that differentiates Umoja from conventional autologous, allogeneic, and other in vivo cell-therapy approaches.
  • Evaluate emerging clinical data, competitive intelligence, and scientific developments to inform development plans.
  • Serve as a key contributor to portfolio prioritization, resource planning, and investment decisions.
  • Drive accountability, operational excellence, and cross-functional collaboration.
  • Ensure appropriate staffing, vendor management, and resource allocation across programs.
  • Ensure clinical studies are conducted on time, within budget, and in compliance with regulatory requirements.
  • Lead clinical governance processes, risk management, and portfolio prioritization.
  • Oversee safety monitoring, data quality, and clinical study reporting.
  • Ensure inspection readiness and compliance with GCP, ICH, FDA, and global regulations.
  • Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed.
  • Partner with Regulatory Affairs in preparing global regulatory submissions and agency interactions.
  • Participate in meetings with health authorities, including FDA, EMA, and other international agencies.
  • Support preparation of briefing documents, submission packages, and responses to regulatory inquiries.
  • Build and lead a network of external scientific and clinical advisors, establishing Umoja as a preferred partner for investigators, thought leaders, vendors, partners, and scientific organizations in hematologic oncology, cell therapy and autoimmune field.

The successful candidate will have:
  • Significant experience within biotechnology, pharmaceutical, or related life sciences organizations.
  • Prior experience leading clinical development functions and multidisciplinary teams is highly preferred.
  • Demonstrated success leading clinical programs through multiple stages of development, including late-stage and registration-enabling studies.
  • Experience supporting regulatory interactions and submissions.
  • Cell and gene therapy or advanced modality experience preferred.
  • Hematology/oncology, immunology, rheumatology, or advanced therapeutic experience strongly preferred.
  • Strategic thinker with strong scientific and business acumen.
  • Proven ability to lead and scale high-performing teams.
  • Excellent communication, influence, and stakeholder management skills.
  • Demonstrated ability to operate effectively in a dynamic, fast-paced biotech environment.

Physical Requirements:
  • The ideal candidate will be able to work onsite based out of our Seattle, WA office at least 2 days/week. There may be the ability to work remotely on the west coast and travel to Seattle, WA at least 5 days/month.
  • Ability to travel domestically and, if applicable, internationally (typically up to 30-50%, depending on role), including air travel and extended periods away from home.
  • Ability to attend and actively participate in external meetings, some of which may require travel.
  • Ability to sit for prolonged periods of time.

Salary Range: $320,000 - $400,000
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

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