Careers

OnCusp Therapeutics is transforming a growing portfolio of leading-edge molecules into innovative treatments that bring help and hope to cancer patients worldwide.

Our success is rooted in our exceptional team, and we are always looking for additional passionate, talented individuals. Our corporate culture is a vibrant blend of Asia and the West, and many positions are geographically flexible. We grant stock options to every employee to share our success with everyone who helps make it possible. Business offices are in New York and Shanghai.

Join Our Team

We are building a first-class team in the US and China. Our team shares the desire to deliver help and hope to cancer patients worldwide. We offer a flexible hybrid and remote structure and excellent health and financial benefits. Explore our job openings below.

  • Employee Stock Ownership Plan
  • Competitive Compensation & Benefits Package
  • Generous 401(k) Company Match with No Vesting Period(US)
  • Health Savings Account(US)

Job Opportunities

Division
  • Development
  • CMC
  • BD
  • Finance
  • R&D
  • Senior/Executive Director, Clinical Operations

    • Division: Development
    • Location: NY/NJ preferred, but flexible regarding remote location
    • Direct Supervisor: Chief Development Officer, Head of R&D

    SCOPE AND RESPONSIBILITIES

    The Clinical Operations Leader will provide strategic and operational leadership of clinical studies, including leading the creation of the clinical operations team, strategy and patient recruitment, and ensure compliance of all relevant regulatory guidelines

    The successful candidate will recruit and lead a team of clinical operations professionals who will oversee the strategy for implementation and the execution of all OnCusp-sponsored clinical trials. This leader of Clinical Operations will directly manage program level responsibilities, including budget, timeline and drug supply management and forecasting and will support efforts in the planning, execution, oversight and reporting of oncology clinical trials, with a focus on first-in-human Phase I trials Additionally, they will be the primary operational contact for the study(ies) and lead a clinical cross-functional team that includes both internal and external resources to support the execution of the study. Reporting into the Chief Development Officer, the ideal candidate will have an opportunity to help shape the company’s culture and values and future

    Responsibilities will include:

    • Building/evolution and leadership of the clinical operations function and translating the operational strategy from the pre-IND phase to full development

    • Development of clinical operational strategy and shaping the clinical development strategy and plan in collaboration with Clinical, Program Leadership and Project Management functions within OnCusp

    • All operational execution across multiple clinical programs, including leading clinical outsourcing, CRO management, and trial site management

    • Leading the full-service CRO and other third-party vendor selection process, specification development, and management/oversight of all clinical trial-related partners and vendors

    • Working closely with clinical development and CROs to ensure high quality data is captured, cleaned and stored in a timely manner

    • Leading the operational strategy and execution for identifying, recruiting and patients for study inclusion

    • Leading the development and continuous improvement of clinical and translational SOPs and providing oversight of clinical monitoring quality and adherence to established processes and plans. Responsible for data quality and study execution under GCP/ICH guidelines

    • Developing, managing, and maintaining study deliverables (i.e., timelines, all study plans, etc.) through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions

    • Proactively identifying potential risks and developing and implementing action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs

    • In partnership with Clinical leadership, providing oversight to ensure safety concerns and/or adverse events are identified; developing and implementing corrective actions accordingly, and participating in internal/external study related audits, as needed

    • Liaising with study investigators, research staff, and external partners to support clinical studies and drive enrollment. Performing external study feasibility with investigators for trials in start-up

    • In partnership with our CROs, overseeing preparation of all applicable documents required for the conduct of the study (e.g., Project Plan, Risk Management Plan, Study and site Monitoring Plans, Trial Master File, Biospecimen lab manuals)

    • Contributing to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority briefing books, clinical study protocol and consent forms, regulatory documents including submissions to IRBs and ECs, clinical study reports [CSR] and submissions) and other study related documents assuring quality and consistency

    DESIRED PROFESSIONAL QUALIFICATIONS

    • Proven leadership of Oncology-specific clinical operations functions and execution of clinical trials

    • Successful track record of effective recruiting and leadership of clinical operations talent

    • Experience developing, implementing, and leading clinical trials, and building clinical operations infrastructure

    • Early phase (Phase I-II) clinical trial experience required

    • Excellent organizational skills and attention to detail

    • Proven ability to prioritize competing demands to successfully meet deadlines and project milestones 

    • Driven to operate with a sense of urgency 

    • Ability to find creative solutions 

    • Strong collaborative, leadership and communication skills 

    • Financial forecasting, budgeting and resourcing experience

    • Effective teamwork and teambuilding skills 

    • Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures

    DESIRED PERSONAL ATTRIBUTES

    • As a member of a small and robustly growing early-stage company, a “no task too small” and “no task too large” attitude is needed

    • Exceptional communication skills, a commitment to achieving a high level of accuracy, and excellent attention to detail

    • An individual who thrives on direct accountability for a high-performing Clinical Operations function and enjoys the accountability of working in a fast-paced, entrepreneurial environment

    • A winning mindset, projecting a passion for patients, high-energy and a desire to achieve, balanced with humility, self-awareness, and maturity

    • A continuous focus on results and meeting or exceeding expectations

    • Highly developed people skills, including teamwork, and cross-functional collaboration

    • A positive “can-do” attitude. Well-developed people skills. An ability to project calm, seasoned leadership no matter what the challenges are

    • A self-starter with a high degree of energy, independence, initiative, and self-motivation, combined with a superior inclination towards delivering results, as illustrated by an ability to instil a sense of pace and urgency into their organization. An individual who moves fast and decisively in all circumstances, with a passion for growing the Company

    • A strong focus on deliverables, performance and results. An ability to track performance against measurable metrics

    • A non-pretentious, entrepreneurial mind-set. An individual focused on delivering great results

    • In the promotion of the health and safety of all OnCusp employee’s, Applicants should be fully vaccinated against COVID-19, unless subject to the reasonable accommodation provisions of Title VII and the ADA and other EEO considerations

    EDUCATION

    BS/BA Degree with relevant pharmaceutical and/or biotech experience in Oncology clinical operations. Advanced degree preferred

  • Manager to Director, Project Management (preclinical)

    • Division: Development
    • Location: CN
    • Direct Supervisor: Chief Development Officer

    Position Summary:

    Responsible for overall team leadership to ensure robust and balanced cross-functional planning, decision-making, implementation, monitoring, and reporting for one or multiple related programs to ensure strong alignment between Research/Development/ Lifecycle strategy (if applicable) and operational execution by the GPT

    Be able to both provide strategic vision and guide the team to develop integrated plans for successfully executing the strategy

    Support the development of publications arising from studies and other relevant initiatives

    Highly skilled at meeting management / facilitation

    Responsibilities:

    Project planning

    Create strategic and operational objectives and integrated tactical plans to drive program goals.  Drive team alignment around these objectives and plans

    Ensure the operational deliverables of the project are achieved on or ahead of schedule and within budget such that they meet the desired product profile criteria

    Define and track scope, risks, budget/costs and time, critical path

    Maintain the overall development plans and enterprise portfolio inputs

    Drive team meetings/agendas/minutes/action items including decision and action logs

    Ensures that teams work effectively to move the program forward

    Coordinate preclinical development studies

    Defining strategies, together with the project team, for the early development of PCCs

    Forecasting and tracking on departmental budget

    Execution

    Drive new asset discovery projects through engagement of external partners and labs (academic, biotech, CRO) to drive lead discovery and optimization

    Contribute to design, plan, and execution of all needed preclinical studies 

    Managing the selection and outsourcing of preclinical studies to Contract Research Organizations (CROs) to provide data necessary to support IND and First-in-Human Phase I clinical trial

    Support external engagements with KOLs/experts to gain input on in-licensing opportunities and pre-clinical / clinical development strategy by ensuring appropriate CDAs, consulting agreements, scope of work, questions, compilation of feedback, timelines, payments, etc

    Review and validation of study documentation, analysis and discussion about the results, with OnCusp staff, CROs or external experts 

    Writing / updating of the preclinical part of the regulatory documents (IMPD, IND, IB) 

    Manage the transition from preclinical development to Phase I/Proof of Concept (POC) clinical trials

    Managing development issues through close interaction with research and development teammates 

    Enterprise support

    Writing of OnCusp SOPs

    Support organizational and portfolio planning, SOPs and governance processes, as needed

    Create a safe, open-communication work environment

    Qualifications:

    Required:

    Advanced degree (MS, Ph.D., MD) in relevant biology, biochemistry or related discipline preferred

    10+ years of biotechnology experience with drug development expertise

    Effective in communication skills both verbal and written; listens and understands well

    Extensive knowledge and experience in project management discipline and its application to drug R&D

    Good oral and written communication skills

    Preferred:

    Proactively recognizes needs and problems, and independently identifies and implements effective steps and solutions

    Sustained and successful experience with project management working with cross-disciplinary teams; works well across boundaries in a highly matrix-based organization Strong skills engaging with people from different cultures, backgrounds and perspectives

  • Director / Senior Director, Biologics Scientific Lead

    • Division: R&D
    • Location: NY/NJ preferred, US
    • Direct Supervisor: Vice President, Research

    Responsibilities:

    Partner with R&D Leadership to build a strong portfolio of Oncology assets. This includes scientific evaluation of in-licensing opportunities, contributing to strategic framework of MOAs and modalities for asset prioritization, engaging in discussions with pharma and academic partners around in-licensing and out-licensing options, and leading due diligence activities of preclinical dataset

    Lead the scientific design and execution of novel biologics programs, taking from early discovery and into the clinic

    Evaluate and select features of novel biologic assets

    Work with CROs/partners to create and develop assets to have desired features. Oversee and ensure scientific rigor and desired phenotype of deliverables from partners

    Engage with CDMO partners to drive research and GMP manufacturing of biologics asset for in vitro, in vivo and GLP research studies

    Develop Research portion of IND package for assets. Work with CROs and other partners to provide data necessary to support IND and First-in-Human Phase I clinical trial

    Work with Clinical lead to support deeper understanding of asset biology and potential combinations and supplemental indications

    Supporting the development of publications arising from studies and other relevant initiatives

    Qualifications:

    PhD in biochemistry, molecular/cellular biology, pharmacology, protein engineering or related discipline

    8+ years’ experience in drug discovery and translational research in emerging biotech and/or large Pharma environment

    Track record of success taking biologics programs (mAb, bispecific, ADC) from target ID through IND is required. Well versed in current technology and platforms for generating biologics starting points, which are further developed into preclinical candidate (PCC)

    Demonstrate strong scientific leadership role of progressing biologics programs into IND ready stage. Prior successful experience of managing CROs is required

    Extensive knowledge in cancer biology is critical; immune oncology experience is preferred

    Working knowledge of GLP tox and IND regulatory requirements is strongly preferred

    Experience in development of biomarkers to support clinical assets

    Highly developed people skills, including teamwork, and cross-functional collaboration

    A self-starter with a high degree of energy, independence, initiative, and self-motivation, combined with a superior inclination towards delivering results, as illustrated by an ability to instill a sense of pace and urgency into their organization. An individual who moves fast and decisively in all circumstances, with a passion for growing the Company

    Experienced with Due Diligence of in-licensed assets

    Local to New York City preferred