Accelerating the Global Development of Innovative Biopharmaceutical Products
We have established a deep, global network of biotechs and big Pharmas, providing us with access to unique and best-in-class drug candidates at various development stages, including those coming from the booming life sciences industry in China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, we aim to globalize medicines for patients with a broad range of diseases, with an initial focus in oncology.
When identifying potential candidates, our focus is on compounds that have been validated through rigorous discovery and development processes, potentially mitigating risk while maintaining cost efficiency.
We are proud to be working with the best and brightest minds in the field committed to maximizing patient benefit and have attracted top-tier investors, providing the necessary resources to help us realize our mission of accelerating the global development of innovative biopharma products.
Bing Yao, PhD
Chief Executive Officer
Stuart Lutzker, MD, PhD
Chief Medical Officer
Robin Lachapelle, MA
Chief Administrative Officer
Yang Wang, PhD
Chief Technology Officer
Jerry Hsu, MD, PhD
Senior Vice President, Clinical Development
Senior Vice President, Development Operations and Business Management
Jack Huang, M.D., Ph.D.
VP and Head of Drug Safety and Pharmacovigilance
VP, Portfolio, Project & Alliance Management
Vice President, Head of Quality and GxP Compliance
Jin Zhu, Ph.D.
VP, Head of Biometrics
Luna Musib, Ph.D.
Vice President, Clinical Pharmacology
Miki Yamamoto, PhD
Vice President, Regulatory Affairs
Fatema Legrand, PhD
Senior Director Clinical Research
Michael Clark, CPA
Controller & Director of Finance
Jessica Marroquin, J.D.
Associate Director, Legal and Contracts
Senior Clinical Trial Manager
At Arrivent, we are building a skilled and passionate team with a breadth of experience across the biotech sector. While we have diverse backgrounds, we share a common goal of advancing therapies for patients in areas of unmet need. We work with a sense of urgency and purpose, foster a collaborative culture that prioritizes cross-functional learning and reward our employees with highly competitive benefits that prioritize health and fiscal wellness, as well as professional development.
We invite you to explore our career opportunities. All applicants are considered for all positions without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical/mental disability, severe/morbid obesity, medical condition, military/veteran status, genetic information, marital status, ethnicity, alienage or any other protected classification, in accordance with applicable federal, state, and local laws. Equal access to programs, services, and employment is available to all qualified persons.
The Director of Biostatistics will provide statistical leadership, oversight, and statistical expertise to lead at least one molecule and support the clinical development of multiple clinical trials. This position will be based in the San Francisco Bay Area.
- Oversee and lead statistical activities as the lead biostatistician for at least one molecule
- Provide scientifically sound statistical input into clinical development plans, protocol development and sample size/power calculations
- Lead the development of statistical analysis plans for individual clinical trials and integrated summary of efficacy/safety of multiple trials; help the team to interpret the study results and contribute to Clinical Study Report(s)
- Contribute to the development of department SOPs and working instructions
- Review and provide feedback to Case Report Forms, CRF completion guidelines, data transfer agreement and data review plans
- Oversee and manage CRO’s activities to ensure that the deliverables are high quality and on time
- Lead the development of Tables/Listings/Figures; review and/or validate SDTM/Adam specifications/data sets and TLFs
- Apply innovative statistical methodologies to trial designs and analyses (e.g., modeling and simulation, Bayesian statistics, etc.)
- Participate in meetings with regulatory agencies; contribute to the pre-meeting packages and prepare responses to agency’s requests/questions
- Perform ad-hoc analyses and exploratory biomarker analyses
- Collaborate closely with statistical programming, clinical science, data management, clinical operation, pharmacovigilance, and regulatory to ensure operational excellence
Required/Preferred Education, Skills, and Qualifications
- D. or a master’s degree in statistics or related field with relevant experience in biotechnology or pharmaceutical industry.
- PhD with a minimum of 8 years
- Masters with a minimum of 10 years
- Solid knowledge of statistical methodologies and experimental designs
- Advanced skills in statistical software for sample size calculation; advanced skills in SAS and R programming
- Experience in leading statistical activities from first-in-human trials to later phases of clinical development
- Extensive knowledge of CDISC standard
- Oversight experience managing CROs
- Oncology experience is required
- Experience in leading NDA/BLA submission and/or experience leading ISS/ISE is a plus
- Thorough knowledge of drug development process and regulatory guidance
- Solid understanding of ICH/GCP guidelines
- Ability to prioritize and manage multiple tasks simultaneously
- Excellent communication/interaction skills and ability to collaborate with a global multicultural team
The Associate Director of Clinical Data Management will be responsible for leading and managing the Clinical Data Management (CDM) function to support various projects. This position will report to the head of Biometrics. West coast time zone preferred.
- Lead or participate in the development, review and implementation of processes, SOPs, and standard templates for clinical data management (CDM)
- Provide direction and leadership in CRO and vendor selection and management
- Oversee CRO’s activities to ensure the quality of deliverables and that timelines are met
- Ensure that the CDM related documentation required to support regulatory submissions and inspections are maintained to the standard required
- Collaborate closely with clinical operation, clinical science, biostatistics, statistical programming, drug safety, and regulatory to ensure operational excellence
- Lead and oversee all data management activities for multiple clinical trials, including but not limited to design and completion guidelines for eCRF, design and testing of EDC systems, development of edit checks, development of data management plan, development of data transfer agreement, SAE reconciliation, database freeze and lock activities
- Participate in the generation and approval of budgets and timelines
Required/Preferred Education, Skills, and Qualifications
- BA/BS or higher education
- 8+ years of experience in CDM in biotechnology or pharmaceutical industry
- Hands-on experience with mainstream EDC systems (e.g. Medidata RAVE, Inform, etc)
- Solid understanding of CDASH and CDISC standard
- Extensive experience managing CROs
- Oncology experience in solid tumor is required
- Experience with pivotal clinical trials conducted globally in successful NDA/BLA submission is preferred
- Thorough knowledge of clinical data management and its role in the drug development process
- Solid understanding of ICH/GCP guidelines as they relate to clinical data management
- Ability to prioritize and handle multiple tasks simultaneously
- Excellent communication/interaction skills and ability to work with a global multicultural team
The Head of Cancer Biology will play a critical role in building the non-clinical stage portfolio for ArriVent by scientifically evaluating non-clinical stage assets for in-licensing, establishing Research collaborations with innovative biotechs globally and providing scientific input into these and other programs as they advance towards clinical testing and once in the clinic. This role will report to the President of R&D.
- Partner with the Business Development team and consultants in Chemistry, Toxicology and Pharmacology to identify suitable Research/pre-IND stage molecules for potential in-licensing and co-development.
- Aid in advancing partnering opportunities through the deal funnel by rigorously assessing the science behind the target and the qualities of the lead molecule versus competitor molecules.
- Contribute to the identification of biotechs with innovative therapies for Research stage partnerships and oversee projects
- Design and where required execute Research plans through CROs to demonstrate MOA for IND and to support the CDP
- Where appropriate serve as the Team leader for Research stage programs as they advance to IND including working with consultants for Toxicology and Pharmacology
- Author scientific background section of regulatory documents
- Attend scientific conferences to stay abreast of new developments
- Maintain presence in professional industry networks and represent the company in the industry associations
Experience & Qualifications
- Advanced scientific degree (PhD) in Cancer Biology or related discipline
- A minimum of 10 years of experience beyond PhD including at least 7 years of Pharmaceutical Research experience in oncology indications
- Experience working with BD and consultants to evaluate drug candidates for licensing, collaboration, or acquisitions
- Experience in defining target candidate profiles and competitor benchmarking including for small molecules
- Strong experience in defining and executing preclinical strategy for oncology programs
- Extensive understanding of in vitro and in vivo systems for demonstrating MOA
- Experience in assembling IND packages including authoring scientific sections
- Experience overseeing CROs and contractors
- Experience in small molecules including non-clinical pharmacology
- Ability to work collaboratively with Research partners, consultants and internal team to advance non-clinical stage programs
- Strong problem-solving and quantitative skills
- Excellent written and communication skills
- Strategic thinker with proven ability to evaluate the strategic implications of business development decisions
- A strong professional presence with peers
- West coast location required