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
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 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 and will be based in the San Francisco Bay Area.
- 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
Summary of Position
Arrivent Biopharma is looking for a highly motivated, entrepreneurial individual to lead Chemical Development for small molecules (including payload for Antibody Drug Conjugates) from pre-clinical to NDA, and post approval life cycle management.
- Lead CMC development with partners and CDMOs from process development (API, formulation, analytical method) to clinical and commercial material manufacturing (API and DP). Generate CMC strategy, timeline, and budget to advance clinical trials and product launch.
- Lead preparation and review of CMC sections related to IND and NDA submissions. Attend meetings with FDA, EMEA and prepared responses to agency questions.
- Serve as the subject matter expert for designing and optimizing chemical manufacturing processes taking consideration of speed, quality, cost, scalability, and reproducibility.
- Support tech transfer, problem solving when development or manufacturing issues arise at CDMOs. Review development plan/reports, tech transfer documents and batch records.
Desired Skills and Experience
- Experience in leading small molecule CMC team for clinical and commercial products.
- Author/review CTD for NDA filings. Familiar with FDA, EMEA, and PMDA requirements. Representing CMC in meetings with regulatory agency.
- Design and implement new chemical routes and processes suitable for scale-up. Ability to analyze and interpret complex chemistry problems and provide solutions.
- Knowledge and experience in payload synthesis for Antibody Drug Conjugates) is desired.
- Knowledge and experience in small molecule analytics or formulation development is a plus.
- Strong communication and influencing skills.
- A PhD in Organic Chemistry, Chemical Engineering or related filed with 7+ years of experience; BSc/MSc with relevant industrial experience to an equivalent level
ArriVent Biopharma, Inc. is looking for a Head of Translational Research to join our management team. This individual will lead all aspects of preclinical research and biomarker development for ArriVent as it grows its pipeline and advances drugs into the clinic. This position will report to the Chief Medical Officer and will be based in either the Bay Area or Gaithersburg MD area.
Together with the Head of Business Development, develop a scientific roadmap for identifying and evaluating new research stage opportunities to expand the ArriVent oncology pipeline including new drug concepts and platform expansions
Serve as research lead for due diligence assessments
Provide scientific leadership and serve as point-person accountable for translational research strategy and biomarker discovery/validation on projects and
Collaborate closely and partner with multi-functional clinical program teams (e.g., Pharmacology, Clinical Development, Safety, etc.) to develop and build translation research packages to support clinical biomarker strategic development as well as implementation of the biomarker plan in the clinic.
Employ non-clinical models to define biomarkers and pharmacodynamic assays for the identification of patients, mechanisms of action, mechanisms of resistance, etc. to aid in decision making on developability of drug molecules
Oversee research collaborations with partner companies, serving as internal lead
Lead in selecting and managing Research CROs to (1) conduct translational research to aide in development of ArriVent pipeline including scientific rationale, indication selection and combination strategy and (2) develop work plans and oversee evaluation by CROs of predictive and pharmacodynamic biomarkers from clinical trials and procured samples.
Provide input and help to author regulatory (e.g., IND and IDE filings) as well as scientific communications and publications pertaining to ArriVent pipeline molecules from early development (pre-IND) through late-stage development (Phase 3 and NDA filings).
Advanced degree (MD or PhD) in Molecular Biology, Immunology or related field and 20+ years’ industrial experience or an equivalent combination of education and experience including 10+ years in relevant disciplines critical to translational research with established track record for advancing programs from Research into the clinic
Global Oncology drug development experience in either biotech or pharmaceutical industry including transitioning programs from Research stage into IND studies and the clinic. Activities should include conducting non-clinical proof of concept studies and biomarker studies.
Proven history of building relationships and fostering engagement across multiple stakeholders, including the board, senior management, operational levels, suppliers, and business partners.
Experience collaborating with biologists and chemists to generate in-vivo target validation data and establishing PK/PD and biomarker correlations to inform clinical studies.
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
In depth knowledge of regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
Companion diagnostics development experience a plus
Demonstrated ability to work in a fast-paced highly matrixed small company environment
Ability to work with a global multicultural team