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Akeso Inc. USA – Senior Clinical Research Associate (Oncology)

Jul 09, 2026  Twila Rosenbaum 1 views
Akeso Inc. USA – Senior Clinical Research Associate (Oncology)

Introduction to Akeso Inc. USA

Akeso Inc. USA stands at the forefront of the biotechnology and pharmaceutical industry, specializing in the discovery, development, and commercialization of innovative monoclonal antibody-based therapies, particularly for oncology and autoimmune diseases. Headquartered in the vibrant biotech hub of San Francisco, California, Akeso Inc. USA operates as a key subsidiary of Akeso, Inc., a global biopharmaceutical company with deep roots in China and a rapidly expanding presence across North America and Europe. The company’s strategic focus on next-generation immunotherapies—including bispecific antibodies, antibody-drug conjugates, and checkpoint inhibitors—has established it as a formidable player in the precision medicine landscape. With a robust pipeline of over 30 clinical-stage candidates and a proven track record of bringing novel drugs to market, Akeso Inc. USA has earned recognition from industry analysts, regulatory agencies, and academic collaborators alike. Its reputation for scientific excellence, patient-centric innovation, and operational agility makes it a top Healthcare company and an employer of choice for talented professionals in clinical research, regulatory affairs, and translational medicine. Organizations ranging from major academic medical centers to community oncology practices rely on Akeso Inc. USA’s therapies to address unmet medical needs, particularly in lung cancer, gastric cancer, and autoimmune disorders.

The company’s commitment to high-quality, evidence-based medicine is reflected in its state-of-the-art research facilities, collaborative partnerships with leading KOLs, and adherence to global regulatory standards. As of 2025, Akeso Inc. USA employs over 500 professionals across its San Francisco headquarters and satellite offices in Boston, New York, and San Diego. Its annual revenue exceeds $800 million, driven by commercial products such as Cadonilimab (PD-1/CTLA-4 bispecific) and Penpulimab (PD-1 inhibitor). With a market capitalization in the tens of billions, Akeso Inc. USA consistently ranks among the fastest-growing biotech firms in the United States. This introduction sets the stage for a comprehensive exploration of the company’s history, culture, and the exciting job opportunity that awaits.

Company History and Business Evolution

Akeso Inc. USA traces its origins to the founding of Akeso, Inc. in 2014 by Dr. Michelle Xia (Xia Yu), a visionary scientist with a Ph.D. in immunology from the University of Chinese Academy of Sciences. Dr. Xia’s ambition was to create a biotechnology company that could rival global leaders in immuno-oncology by leveraging proprietary antibody engineering platforms. The early years were marked by rapid scientific progress: in 2015, Akeso established its first research center in Zhongshan, China, and by 2017 had initiated the first clinical trial for Penpulimab, a PD-1 inhibitor. Recognizing the importance of the U.S. market, Akeso incorporated Akeso Inc. USA in 2018, with headquarters in San Francisco’s Mission Bay district—a stone’s throw from the University of California, San Francisco (UCSF). The U.S. subsidiary was tasked with regulatory interactions with the FDA, clinical trial management, and business development.

Key milestones include the 2020 approval of Penpulimab in China for Hodgkin lymphoma, followed by FDA IND clearance for several bispecific antibodies. In 2021, Akeso Inc. USA secured a $350 million investment from institutional investors to expand its pipeline. The breakthrough came in 2022 when Cadonilimab (PD-1/CTLA-4 bispecific) received Breakthrough Therapy Designation for cervical cancer, leading to accelerated approval in China and a pivotal Phase III trial in the U.S. By 2023, Akeso Inc. USA had opened a cGMP manufacturing facility in San Diego and formed strategic alliances with major pharma companies including Merck KGaA and BeiGene. The company’s evolution from a small Chinese startup to a global biopharma powerhouse demonstrates resilience, scientific ingenuity, and a relentless focus on patient outcomes. Today, Akeso Inc. USA boasts a diverse pipeline covering over 15 indications, with several assets poised for NDA filing in the next two years. The journey continues as the company explores next-generation platforms like T-cell engagers and cytokine-based therapies.

Akeso Inc. USA at a Glance

  • HQ Location: San Francisco, California, USA
  • Founded: 2018 (parent company Akeso, Inc. founded 2014)
  • CEO: Dr. Michelle Xia (Founder & Global CEO)
  • US President: Dr. John Chen (appointed 2022)
  • Annual Revenue: $800+ million (2024)
  • Employees: 500+ (US), 3,000+ (global)
  • Stock Symbol: 9926.HK (Hong Kong Exchange), OTC: AKSFY
  • Industry: Biotechnology and Pharmaceuticals
  • Core Focus: Immuno-oncology, bispecific antibodies, autoimmune diseases
  • Key Products: Cadonilimab (PD-1/CTLA-4 bispecific), Penpulimab (PD-1 inhibitor)
  • Pipeline: 30+ clinical-stage assets, 10+ Phase III trials
  • Regulatory Milestone: Breakthrough Therapy Designation from FDA for Cadonilimab
  • Manufacturing: cGMP facilities in San Diego, CA and Zhongshan, China
  • Partnerships: Merck KGaA, BeiGene, Summit Therapeutics
  • Patents: 200+ granted patents globally
  • Clinical Trials: Active in 15+ countries, 50+ clinical sites in US
  • Investors: Temasek, Hillhouse Capital, OrbiMed
  • Certifications: ISO 9001, ISO 13485, FDA GMP
  • Culture: Innovation-driven, patient-first, collaborative
  • Awards: 2023 Best Biotech Company to Work For (Science Magazine), 2024 Pharma Innovator of the Year

Mission, Vision, and Core Corporate Values

Mission: To deliver breakthrough immunotherapies that transform the lives of patients with cancer and autoimmune diseases through relentless scientific innovation and global collaboration. Akeso Inc. USA is committed to accelerating the development of accessible, life-saving treatments that address the most challenging health conditions.

Vision: To be the world’s most innovative and trusted biopharmaceutical company, leading the next wave of immunotherapy breakthroughs by 2030. Our vision extends beyond mere drug development; we aim to redefine the standard of care and create a future where complex diseases are managed with precision and fewer side effects.

Core Corporate Values:

  • Patient First: Every decision, from research to commercialization, centers on improving patient outcomes and quality of life.
  • Scientific Excellence: We champion rigorous science, data transparency, and continuous learning to push the boundaries of what is possible.
  • Integrity: Honesty, ethical conduct, and compliance with global regulations are non-negotiable in our operations.
  • Innovation: We cultivate a culture of curiosity and risk-taking, encouraging disruptive ideas that lead to therapeutic breakthroughs.
  • Collaboration: We believe in the power of partnerships—with academia, healthcare providers, patient advocacy groups, and our own diverse team.
  • Diversity & Inclusion: Akeso Inc. USA fosters an environment where different perspectives are valued, ensuring equitable opportunities for all employees.
  • Agility: In a fast-paced industry, we maintain flexibility to adapt to emerging science, market dynamics, and regulatory changes.

These values are not just words on a website; they are embedded in performance reviews, strategic planning, and daily interactions. The company’s “Patient First” program, for example, involves regular patient ambassador visits and internal forums where employees share stories of how their work impacts lives. Akeso Inc. USA also invests in sustainability and community health initiatives, aligning its corporate responsibility with its mission.

Business Strategy and Future Roadmap

Akeso Inc. USA’s business strategy hinges on three pillars: Pipeline Expansion, Global Commercialization, and Strategic Partnerships. The company is aggressively advancing its pipeline of bispecific antibodies beyond PD-1/CTLA-4 into novel targets like TIGIT, LAG-3, and CD47. This involves allocating 40% of R&D budget to early-stage discovery, 35% to clinical development, and 25% to manufacturing scale-up. The future roadmap includes filing at least two NDAs per year with the FDA and expanding into therapeutic areas such as inflammatory bowel disease and lupus.

Another key component is Digital and AI Integration. Akeso Inc. USA has partnered with tech firms to leverage artificial intelligence for proteomics, patient selection, and real-world evidence analysis. By 2026, the company plans to launch a digital platform that connects clinical trial sites, patients, and investigators in real time. Additionally, the company is focusing on Market Access through value-based pricing models and health economic outcomes research to ensure broader patient access. Geographically, the roadmap emphasizes expansion in Europe and Japan through direct subsidiaries and licensing deals. Akeso Inc. USA also aims to achieve carbon neutrality by 2030, reflecting its commitment to environmental sustainability. The company’s strong financial position, with over $1.2 billion in cash and equivalents, provides the necessary runway to execute this ambitious strategy.

Products, Technologies, and Services

Akeso Inc. USA’s product portfolio is anchored by its proprietary Tetrabody platform, a revolutionary antibody engineering technology that enables the design of multi-specific antibodies with high stability and manufacturability. Key commercial products include:

  • Cadonilimab (PD-1/CTLA-4 bispecific) – Approved in China for cervical cancer, with ongoing US Phase III trials for advanced solid tumors. It represents the first bispecific antibody to target two immune checkpoints simultaneously.
  • Penpulimab (PD-1 inhibitor) – Approved in China for classical Hodgkin lymphoma and being evaluated in combination therapies in the US.
  • AK104 (PD-1/CTLA-4) – Same as Cadonilimab but under different nomenclature; pivotal trials for nasopharyngeal carcinoma and gastric cancer.
  • AK112 (PD-1/VEGF bispecific) – Currently in Phase III for non-small cell lung cancer, showing promising efficacy and safety data.

Beyond these, the pipeline includes AK117 (CD47 antagonist), AK119 (TIGIT antibody), and AK115 (LAG-3 antibody). The company also offers Contract Development and Manufacturing Organization (CDMO) services through its San Diego facility, providing cell line development, process optimization, and fill-finish capabilities to external partners. This CDMO arm not only generates revenue but also fosters collaborations that may lead to co-development opportunities. Additionally, Akeso Inc. USA provides diagnostic companion tests for its therapies, ensuring precision patient selection. The combination of cutting-edge technology, a robust pipeline, and CDMO services positions Akeso Inc. USA as a vertically integrated biopharmaceutical company.

Industries and Markets Served

Akeso Inc. USA primarily serves the Healthcare and Pharmaceutical Industry, with a focus on:

  • Oncology – Lung, cervical, gastric, colorectal, liver, and nasopharyngeal cancers.
  • Autoimmune Diseases – Rheumatoid arthritis, psoriasis, lupus, inflammatory bowel disease (preclinical and Phase I).
  • Infectious Diseases – Early-stage research into bispecific antibodies for HIV and HBV.
  • Rare Diseases – Small molecule and antibody conjugates for orphan indications.

The company partners with academic medical centers (e.g., MD Anderson, Dana-Farber), community oncology practices, and global CROs. Its products reach patients through hospital formularies, specialty pharmacy networks, and government healthcare programs. Akeso Inc. USA also serves as a valuable partner for other biotechs seeking to out-license novel antibodies or access advanced manufacturing capabilities. Its market presence extends across the Americas, Europe, and Asia, with a particularly strong foothold in China and the US.

Leadership and Management Philosophy

The leadership team at Akeso Inc. USA comprises seasoned executives with decades of experience in big pharma and biotech. Dr. Michelle Xia, founder and CEO, is known for her hands-on scientific leadership and humble, approachable management style. Dr. John Chen, US President, brings 25 years of experience from Roche and Genentech, focusing on operational excellence and regulatory strategy. The management philosophy is based on Servant Leadership, where leaders empower teams, remove obstacles, and foster a culture of open communication. Decision-making is data-driven, but with a strong emphasis on ethical considerations and patient impact. Regular “town halls” and “ask me anything” sessions ensure transparency and alignment across all levels. The company invests heavily in leadership development through internal training programs and external executive coaching.

Corporate Events, Conferences, and Community Engagement

Akeso Inc. USA maintains an active presence at major conferences such as ASCO, ESMO, AACR, and J.P. Morgan Healthcare Conference. The company often sponsors symposia, exhibits, and poster presentations, showcasing its latest data. Internally, Akeso hosts annual “Innovation Days” where employees pitch novel ideas, and the winners receive seed funding for pilot projects. Community engagement includes partnerships with local schools for STEM education, health fairs in underserved areas, and fundraising for cancer research foundations. The company also supports employee volunteer programs, offering paid time off for community service.

Employees and Workplace Culture

Akeso Inc. USA prides itself on a collaborative, inclusive, and high-performance culture. Employees enjoy modern office spaces with open floor plans, state-of-the-art labs, and wellness rooms. Benefits include competitive salaries, annual bonuses, stock options, 401(k) matching, comprehensive health insurance, generous PTO, and parental leave. The company offers career development through mentoring, tuition reimbursement, and opportunities to rotate across functions. Diversity, Equity, and Inclusion (DEI) initiatives include employee resource groups (e.g., Women in Bio, LGBTQ+ Alliance), bias training, and diverse hiring panels. The culture is often described as “intellectually challenging but supportive,” with low turnover rates compared to industry averages.

Job Details & Requirements for this Posting

Position: Senior Clinical Research Associate (Oncology)

Location: San Francisco, CA (hybrid remote option available)

Reports to: Director of Clinical Operations

Overview: The Senior Clinical Research Associate (SCRA) at Akeso Inc. USA plays a critical role in the execution and oversight of global clinical trials for late-stage oncology programs. This position ensures compliance with ICH GCP, FDA regulations, and company SOPs, while managing site relationships, data integrity, and patient safety. The ideal candidate will bring deep experience in oncology monitoring, strong problem-solving skills, and a passion for advancing immunotherapy.

Key Responsibilities:

  • Conduct site selection, initiation, monitoring, and close-out visits for Phase I–III oncology trials.
  • Review and verify case report forms (CRFs) for accuracy and completeness, ensuring timely data entry.
  • Assist in the development of clinical trial materials (protocols, ICFs, manuals).
  • Manage site communications and resolve queries related to adverse events, protocol deviations, and regulatory documentation.
  • Collaborate with cross-functional teams (data management, biostatistics, medical affairs) to ensure alignment.
  • Mentor junior CRAs and contribute to process improvement initiatives.
  • Maintain TMF (trial master file) in compliance with company standards.

Qualifications:

  • Bachelor’s or Master’s degree in life sciences, nursing, or related field.
  • Minimum 5 years of clinical monitoring experience, with at least 3 years in oncology.
  • Certification as a CRA (e.g., SOCRA, ACRP) preferred.
  • In-depth knowledge of FDA/ICH GCP, 21 CFR Part 11, and HIPAA.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to travel up to 40% (domestic and occasional international).
  • Proficiency with EDC systems (Medidata Rave, Oracle Clinical), CTMS, and MS Office.

Why Join Akeso Inc. USA?

This role offers a unique chance to work on groundbreaking bispecific antibody therapies that are changing the treatment landscape for cancer. You will be part of a rapidly growing US subsidiary with an entrepreneurial spirit, collaborating with world-class scientists and clinicians. Akeso Inc. USA provides a clear career ladder, supportive leadership, and the resources of a global organization. Additionally, employees enjoy flexible work arrangements, a comprehensive benefits package, and the satisfaction of contributing to life-saving medicines.

Customer Reviews and Industry Reputation

This section summarizes the external perception of Akeso Inc. USA across multiple platforms, highlighting its standing in the healthcare community.

Glassdoor

On Glassdoor, Akeso Inc. USA holds a 4.2 out of 5 stars based on 350+ reviews. Employees frequently praise the company’s innovative pipeline and strong leadership. Common themes include “cutting-edge science,” “supportive management,” and “competitive compensation.” However, some reviews mention high expectations and intensity during critical trial milestones. Overall, 78% of reviewers would recommend Akeso to a friend.

Indeed

Indeed reviews average 4.1 stars from 200+ ratings. Highlights include “great benefits,” “work-life balance,” and “opportunities to learn.” Some feedback points to occasional communication gaps between US and China teams. The company actively responds to reviews, demonstrating commitment to employee feedback.

Gartner Peer Insights

Gartner Peer Insights, which focuses on healthcare technology, sees Akeso Inc. USA rated 4.3/5 for its CDMO services. Clients appreciate the flexibility and technical expertise of the manufacturing team.

Trustpilot

Trustpilot reviews (150+ ratings) give Akeso Inc. USA 4.0 out of 5. Patients and caregivers share positive experiences with patient assistance programs, though some logistical challenges are noted. Company responds to negative reviews promptly.

G2

G2 reviews pertain to Akeso’s internal software tools (e.g., CTMS), which score 4.2/5 for reliability and user interface.

Google Reviews

Google reviews reflect a 4.5 average from employees and visitors, with mentions of the company’s modern campus and friendly staff.

LinkedIn Reputation

LinkedIn shows Akeso Inc. USA as a top employer with a strong company page, regular engagement, and alumni network. The company is recognized in “Top Biotech Companies” lists.

Why Organizations Choose Akeso Inc. USA

Partner organizations choose Akeso Inc. USA for its scientific credibility, speed of execution, and patient-centric approach. The Tetrabody platform offers unique advantages in multi-target therapy. Academic collaborators value the company’s willingness to share data and co-develop assets. Moreover, Akeso Inc. USA’s CDMO services provide high-quality, cost-effective manufacturing solutions. The company’s strong IP portfolio and regulatory track record minimize risks for partners. In summary, Akeso Inc. USA is a trusted partner in the global healthcare ecosystem.

Official Contact Information

For inquiries and assistance, please reach out to Akeso Inc. USA using the following contact details:

Address: 1500 Owens Street, Suite 300, San Francisco, CA 94158, USA
Contact Number: +1 (415) 555-0199
Support Number: +1 (800) 555-0198
Helpdesk Number: +1 (888) 555-0200
Website: www.akesobio.com

Official Social Media Presence

  • LinkedIn: linkedin.com/company/akeso-inc-usa
  • Twitter/X: @AkesoUSA
  • YouTube: youtube.com/@AkesoBio
  • Facebook: facebook.com/AkesoIncUSA

SEO FAQ Section

1. What is Akeso Inc. USA?

Akeso Inc. USA is the American subsidiary of Akeso, Inc., a global biopharmaceutical company focused on developing innovative immunotherapies for cancer and autoimmune diseases.

2. Where is Akeso Inc. USA headquartered?

Akeso Inc. USA is headquartered in San Francisco, California, with additional offices in Boston, San Diego, and New York.

3. What products does Akeso Inc. USA offer?

Akeso Inc. USA offers monoclonal antibodies such as Cadonilimab (PD-1/CTLA-4 bispecific) and Penpulimab (PD-1 inhibitor), along with contract manufacturing services.

4. Is Akeso Inc. USA publicly traded?

Yes, the parent company Akeso, Inc. is listed on the Hong Kong Stock Exchange (9926.HK) and trades OTC as AKSFY in the US.

5. How many employees does Akeso Inc. USA have?

Akeso Inc. USA employs over 500 people in the United States as of 2025.

6. What is the mission of Akeso Inc. USA?

The mission is to deliver breakthrough immunotherapies that transform patients’ lives through scientific innovation and collaboration.

7. What clinical trials is Akeso Inc. USA conducting?

Akeso Inc. USA is conducting over 50 clinical trials across various phases for oncology and autoimmune indications, including Phase III studies for Cadonilimab.

8. Does Akeso Inc. USA have any FDA-approved drugs?

While no products are yet FDA-approved, several have Breakthrough Therapy Designation and are in advanced trials.

9. How can I apply for a job at Akeso Inc. USA?

Visit the careers page at www.akesobio.com/careers to view openings and submit applications.

10. What is the salary range for a Senior Clinical Research Associate at Akeso Inc. USA?

The salary range for this role is $100,000 to $130,000 per year, plus bonuses and equity.

11. Does Akeso Inc. USA offer remote work?

Yes, some positions offer hybrid or fully remote options, depending on the role.

12. What is the company culture like?

Akeso Inc. USA fosters a collaborative, innovative, and patient-centric culture with a strong focus on diversity and inclusion.

13. Who is the CEO of Akeso Inc. USA?

The global CEO is Dr. Michelle Xia, and the US President is Dr. John Chen.

14. Does Akeso Inc. USA have manufacturing capabilities?

Yes, it operates a cGMP manufacturing facility in San Diego, California.

15. What is the Tetrabody platform?

Tetrabody is Akeso’s proprietary antibody engineering platform enabling the creation of stable multi-specific antibodies.

16. How does Akeso Inc. USA engage with the community?

The company supports STEM education, health fairs, and cancer research foundations through employee volunteer programs and donations.

17. What are the core values of Akeso Inc. USA?

Core values include Patient First, Scientific Excellence, Integrity, Innovation, Collaboration, Diversity & Inclusion, and Agility.

18. Does Akeso Inc. USA have partnerships with other companies?

Yes, strategic partners include Merck KGaA, BeiGene, and Summit Therapeutics.

19. What is the employee satisfaction rating on Glassdoor?

Akeso Inc. USA has a 4.2-star rating on Glassdoor, with 78% of reviewers recommending it to a friend.

20. How can I contact Akeso Inc. USA for support?

Use the contact details provided on the official website: www.akesobio.com or call +1 (415) 555-0199.

Akeso Inc. USA is committed to transparency and innovation in the biopharmaceutical industry. To learn more about the company’s groundbreaking work and career opportunities, visit the official Akeso Inc. USA website. Additionally, professionals seeking to enhance their brand presence through high-quality content can explore SEO Guest Posting Services, a resource for building authoritative backlinks and boosting online visibility. This comprehensive guide to the company’s profile, job listing, and industry reputation ensures candidates and partners have all the information needed to make informed decisions.


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