Position Summary

The ArriVent Clinical Development organization is responsible for developing and executing early and late development clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. The Director/Sr Director Clinical Research role provides an exciting opportunity to participate in the future expansion of ArriVent Biopharma, Inc. We are seeking a well-trained individual with strong leadership skills who is driven by science and the desire to develop novel therapies for patients. This individual will have the opportunity for growth and development while working in a vibrant startup environment. The ideal candidate will have a mastery of the drug development process, study document writing, study conduct, data review and reconciliation, as well as the principles of translational medicine.

Specific duties and major responsibilities include:

  • Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of assigned clinical trial activities
  • Lead protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
  • Lead the preparation of study support documents such as charters, medical data review plans, etc. as needed
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
  • Serve as a functional area representative to cross-functional teams, providing oversight and guidance to supporting team members
  • Lead activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent quality data review
  • Lead site-facing activities such as training and serving as primary contact for clinical questions
  • Identify clinical data trends; provide trends and escalate questions to Clinical Lead
  • Develop clinical narrative plan; review clinical narratives
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
  • Draft/review and validation of clinical study reports (CSRs)
  • Support the preparation of various official and regulatory documents for regulatory agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
  • Support clinical development planning (collaboration with clinical development team for provision and analysis of data to support future planning)
  • Work closely with the Medical Monitor/Clinical Lead to assess study progress, ensure proper study conduct and adherence to the protocol, and lead data review, evaluation, and analyses with support from Data Management and Stats and Programming team
  • Present study updates, interim results, and final headline data to internal and/or external stakeholders as required
  • Consistently comply with all governing laws, regulations, ArriVent Standard Operating Procedures (SOPs) and other guidelines

Knowledge, Experience and Skills:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred)
  • Experience Level
    • Director level: 6-8 years of direct drug development experience in a biotech/pharmaceutical company, contract research organization or academic institution
    • Senior Director level: 9+ years of direct drug development experience in a biotech/pharmaceutical company, contract research organization or academic institution
    • Able to work in a fast-paced dynamic organization
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed
    • Excellent verbal and written communication skills as well as interpersonal skills to maintain working relationship with team members to ensure scientific integrity of clinical studies
    • Strong presentation skills: highly effective at summarizing and presenting the key considerations and decision-points
    • Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc., stays focused and on-point, and can raise problems or challenges in a productive and mature manner

    Experienced with Microsoft Office (Word, Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire, MediData Rave, etc.

    ArriVent Biopharma is looking for a talented and highly motivated in-house Senior Clinical Research Associate or Clinical Trial Manager I. This role will work within the Clinical Operations team to provide project-specific and departmental support related to clinical trials execution.

    Key responsibilities:

    • Participates in site outreach and site selection while tracking progress toward selection goals
    • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
    • Works with the CRO and other vendors to expedite site start-up
    • Contributes to cohort management activities including fielding slot requests and tracking
    • Contributes to the review and update of study-related materials including: SIV slides, informed consent form, plans, and manuals
    • Schedules and leads cross-functional adjudication of study documents, as needed
    • Contributes to the review of country/site customizations of study documents
    • Compiles study and site metrics and maintain study trackers, as needed
    • Work with CRAs and sites to resolve data queries
    • Offers guidance on site issues and liaises with other functional groups (Clinical Science, Drug Safety, Pharmacovigilance, etc.) as necessary
    • Prepares and delivers presentations to the study team on study metrics, timelines, and clinical trial status
    • Leads meetings with functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are aligned with project objectives
    • Prepares agendas, documents meeting minutes and tracks open action items across internal and external stakeholders
    • Supports audit/inspection activities as needed
    • Reviews invoices against vendor budgets

    Education & Experience

    • B.A./B.S. with strong emphasis in science and/or biology
    • 4+ year experience with site management (monitoring), Clinical Research Organization background preferred
    • Prior oncology experience preferred

    Knowledge, Skills, & Abilities

    • Strong Excel and/or google sheets skill set
    • Strong organizational skills – able to build and maintain internal filing system for study documents
    • Ability to prioritize and multi-task – comfortable setting outlook rules
    • Knowledge of drug development process
    • Familiarity with: EDC, eTMF, CTMS, etc.
    • Strong oral and written communication skills

    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.

    Key Responsibilities

    • 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.

    Education Requirement

    • A PhD in Organic Chemistry, Chemical Engineering or related field with 7+ years of experience; BSc/MSc with relevant industrial experience to an equivalent level

    The ArriVent Clinical Development organization is responsible for developing and executing early and late development clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients.  This role provides an exciting opportunity to participate in the future expansion of ArriVent Biopharma, Inc. Working in collaboration with the Clinical Development (CD) team this role is responsible for various aspects of ongoing clinical trial program-related activities. These activities encompass, but are not limited to, collaboration on functional area activities during program implementation, clinical study startup/execution/close out, data analysis/reporting and support of HA interactions.

    Essential Duties and Job Functions:

    • Manages the preparation of study protocols, amendments, informed consents, charters, specific sections of study manuals, and other documents as needed with appropriate guidance and supervision.
    • Manages start up activities, including but not limited to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
    • Addresses questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs
    • Manages the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities
    • Prepares and reviews regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs
    • Supports priorities within functional area
    • Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies
    • Is able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development
    • Completes and/or leads other special projects, as and when assigned, or otherwise requested
    • Consistently complies with all governing laws, regulations, ArriVent Standard Operating Procedures (SOPs) and other guidelines

    Knowledge, Experience and Skills:

    • Typically requires an advanced degree such as PharmD or PhD in clinical research or clinical pharmacology
    • 3+ years of relevant scientific and/or drug development experience in a pharmaceutical company, contract research organization or academic institution
    • Able to work in a fast-paced dynamic organization
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed
    • Possesses excellent verbal and written communication skills as well as interpersonal skills to maintain working relationship with team members to ensure scientific integrity of clinical studies
    • Strong presentation skills: highly effective at summarizing and presenting the key considerations and decision-points
    • Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc., stays focused and on-point, and can raise problems or challenges in a productive and mature manner
    • Experienced with Microsoft Office (Word, Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire, MediData Rave, etc.
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