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 Medical Director/Senior Medical Director provides clinical scientific leadership for a program including direct responsibility for clinical development strategy and execution of clinical trials. You will lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions. This position is located in the San Francisco Bay Area in California.
A Typical Day Might Include the Following
- Design and develop smaller, yet robust and innovative Phase 1, 2 or 3 programs.
- Interact effectively and successfully with regulatory agencies.
- Serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions
- Build consensus and lead multi-disciplinary teams towards sound decision-making.
- Develop and implement strategic growth plans.
- Work with external collaborators, including CROs, national institutes and multinational pharmaceutical companies.
- Evaluate external opportunities for partnering or licensing new oncology assets.
This Role Might Be for You If
- You have developed unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
- You have proven knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products.
- You have familiarity with drug-diagnostic co-development.
- You have excellent scientific standing among peers and the ability to address issues with scientific difficulty and creative solutions.
- You are a change agent and driver, adapting to organizational growth, as needed.
Education & Experience
- For this role, we seek a MD or MD/PhD with Hematology/Oncology or relevant clinical training.
Minimum of 3 years of industry experience in clinical development, with experience designing and executing first-in-human through registration-enabling clinical programs.
We have established a deep, global network of biotechs and big Pharmas, providing us with access to unique best-in-class and first-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.
We are seeking a highly motivated individual to join us as a Director, Business Development. In this position, you will take a critical role where your experience in strategic thinking, due diligence, strong project management, scientific understanding and excellent communication and negotiation skills will be central to your success. The ideal location for this position is the San Francisco Bay area however we are also open to the Mid-Atlantic region of the east coast.
- Partner with the Chief Business Officer and other functional leaders to define, design, and implement ArriVent’s overall business development strategy.
- Conduct business development activities consistent with the company’s overall strategy set by the Executive team and the board
- Maintain all existing the partnering network and develop relationships with potential partners, including biopharma companies, bankers, advisors and other external experts.
- Conduct search and evaluation efforts to identify potential partners for current products and new assets.
- Leads the business development execution process, including planning and conducting diligence with functional leads across the organization, and external experts to create diligence reports, business case presentations with recommendations.
- Works closely with the Chief Business Officer to lead and/or assist in developing negotiation strategies.
- Heavily participate in deal structuring, term sheets and contracts negotiations with internal and external legal counsel, as needed.
- Ensure compliance with corporate policies and procedures, as well as healthcare laws and regulations. Continually monitor and evaluate industry trends and integrate learnings into corporate strategy in support of key corporate goals across the company. Performs in-depth evaluations, interpreting competitive landscape.
- Stays abreast of emerging healthcare & pharmaceutical industry trends and assess their potential impact on business strategies.
EXPERIENCE AND QUALIFICATIONS
- 7 years of experience in pharmaceutical/healthcare/biotech business, including track record of identifying and evaluating deals and executing transactions.
- Experience should include participating in multiple successful partnerships or an investment institution/bank/consulting firm focused on the biotech/pharma sector.
- Advanced or graduate degree in Medical/life sciences is strongly preferred. This role requires a working knowledge of drug development and the ability to integrate scientific and clinical knowledge in the business assessment of opportunities.
- Strong analytical and quantitative modeling skills, including proficiency in building forecast and valuation models.
- Excellent interpersonal skill and team oriented. Strong ability to effectively influence and persuade diverse stakeholders in drug development while maintaining high quality and efficiency standards.
- Successful experience in fast-paced entrepreneurial environment.
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 Associate Director/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)
- 3+ 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.