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.

Job Opportunities

Division
  • Development
  • CMC
  • BD
  • Finance
  • R&D
  • Manager to Director, Project Management (preclinical)

    Sep 09, 2021
    • 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

  • Senior Director to Vice President, CMC

    Aug 11, 2021
    • Division: CMC
    • Location: CN / US
    • Direct Supervisor: CEO

    Position Summary:

    Oversee the CMC activities of the company under the supervision of the CEO

    Drive the execution of the CMC projects throughs CRO and CDMOs to meet critical timeline and global quality standard.

    Lead the internal development of drug candidates, drug substances and drug products of the company and build the infrastructure and function team to substantiate it

    Collaborate closely with drug discovery team, regulatory team and clinical team to ensure smooth execution of projects

    Represent the company at conferences, meetings, conventions and other events as CMC representative

    Responsibilities:

    Responsible for providing technical leadership and guidance across CMC development disciplines to all outsourced development and manufacturing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations

    Scope of technical responsibilities include pre-formulation, formulation development, analytical method development and transfer, process development, optimization, scale-up studies/technology transfer, clinical manufacturing, and stability studies

    Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives, milestones, timelines, resources and budgets 

    Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations

    Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership

    Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs. Negotiate, obtain and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners

    Direct/oversee contract manufacturing, testing, packaging and labeling operations for the company’s drug substances and drug products, and ensure timely clinical drug supply for global trials

    Actively manages CMC aspects of IND submissions and other regulatory interactions for relevant products in close collaboration with the involved departments. Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements

    Qualifications:

    PhD in Pharmaceutics or related disciplines 

    10+ years of experience in pharmaceutical or biotechnology CMC management of development programs

    Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions

    Extensive experience in managing CDMOs in different regions for the manufacture of cGMP drug substance and drug product

    Experienced with cGMP manufacturing and IND filings; good working knowledge of relevant US FDA, EMEA and China regulations

    Proven track record of superior interpersonal and communication skills with ability to develop strong positive relationship with senior management as well as all levels of the organization

    Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards

    Proven experience in managing teams, budgets and resources

    Project management skills

    Proven ability for strategic thinking in a complex business environment

    Ability to deal with ambiguity

    Mentorship, innovative thinking, keen industry insight, strong analysis and problem solving

  • Senior Director to Vice President, Business Development & Licensing (US BD Lead)

    Jun 30, 2021
    • Division: BD
    • Location: US
    • Direct Supervisor: CBO

    Position Summary:

    Build on and utilize existing network with the Biotech and Pharmaceutical community and target companies in oncology

    Enhance company’s reputation as a partner of choice for global translational development in oncology

    Generate high quality deal-flow of licensing opportunities (both buy and sell side) in line with company’s Corporate Strategy

    Lead the evaluation of and due diligence on target assets in an efficient and effective manner

    Support target valuation, deal structuring, and negotiation

    Project manage transactions through to completion

    Responsibilities:

    Principal Responsibilities

    Build a robust pipeline of high quality, actionable licensing opportunities through a network of strong relationships

    Identify highly promising pre-clinical, oncology assets based on scientific and industry knowledge

    Coordinate the initial evaluation (including scientific and commercial attractiveness) of opportunities in a lean and efficient manner: directing appropriate resources to focus on the key issues and arriving at clear go/ no-go decisions expeditiously

    Perform required competitive analysis, due diligence, in a thoughtful, thorough, accurate, complete and timely manner

    Support and participate in the negotiation and structuring of transactions that deliver value to the organization

    Lead diligence (internal and external) to deliver clear and concise conclusions in support of final decision-making on deals

    Manage all parties through to completion on a timely basis

    Provide input into the development of wider business unit and corporate strategy

    Preparation of internal review and board briefing documents including substantial quantitative and qualitative analysis of opportunities

    Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with corporate objectives

    Other Responsibilities

    Work on other transactions that fit with corporate strategy, including collaborative research and development agreements and joint ventures

    Undertake external talks and presentations to prospective partners and regularly attend key industry events such as conferences

    Contribute to competitive intelligence activities and to maintenance of professional knowledge management practices

    Carry out other reasonable tasks as required by the CBO

    Principal relationships:

    Internal – Key stakeholders are at Board and Senior Management levels throughout the organization, particularly the CDO, VP of Research, VP of Early Clinical Development and CEO

    External – C-suite executives at target companies, advisors, investors, and entrepreneurs

    Qualifications:

    Education and experience

    Bachelor’s degree demonstrating excellence in science or medicine.  Advanced degree preferred

    5-10yrs + of significant successful business development experience in biotech/pharma with a proven track record in closing deals, both in and out-license

    Prior experience in the oncology space is required

    Dynamic individual, able to demonstrate evidence of being a highly proactive self-starter

    Experience working effectively in multi-disciplinary teams and managing others without formal authority

    Skills and attributes

    Relationship builder as evidenced by a talent in building rapport, managing internal and external relationships, and working effectively across functions and geographies, correspondingly high level of emotional intelligence

    Strong understanding of the latest developments in oncology and the underlying science

    Ability to write high quality succinct business documents in English for Board level audiences

    Ability to understand complex commercial, financial, scientific, medical and legal problems

    Highly articulate and able to communicate effectively with senior audiences internally or externally, be they commercial or scientific

    Strategic thinker as indicated by experience of contributing to the development of corporate or business unit strategy and translating this into appropriate business development goals that are then successfully executed

    Willingness/ability to travel extensively (US, Europe, Asia)

    Able to work with a global team based in both US and China and willing to adapt to flexible working hours due to time zone differences

    Understands the dynamic and requirements of working in a small company

    Proactive nature, with ability to work independently

    Strong team player

  • GL Accountant (US GAAP)

    Jun 30, 2021
    • Division: Finance
    • Location: Shanghai, China
    • Direct Supervisor: Finance Director

    Major Responsibilities and Duties:

    Preparation of journal entry under US GAAP

    Preparation of consolidated financial reports under US GAAP, to ensure the timeliness, accuracy and integrity of the reports

    Assisting in preparing of the quarterly and annual financial analysis reports, to ensure an objective and accurate reflection of the operation status and the related financial index

    Supporting the quarterly / annual financial audit, assisting in preparing basic accounting book, checking and adjusting the journal entries and financials

    Be responsible for collecting and managing all updated knowledge of accounting principles, analyzing the impact for the financial reports related to the gap between PRC GAAP/US GAAP/IFRS

    Be responsible for checking the data of financials of each entity, to ensure accuracy of the inter-co transaction data

    Qualifications:

    US GAAP experience is a must, be familiar with bookkeeping and financial reports under US GAAP

    3 years+ accounting or audit experience

    Bachelor or above

    English as working language with strong communication skills

  • Vice President, Clinical Development

    Jun 30, 2021
    • Division: R&D
    • Location: NY/NJ preferred, US
    • Direct Supervisor: CDO

    Position Summary:

    The role will have broad strategic and operational leadership responsibilities for advancing OnCusp’s innovative pre-clinical and early clinical pipeline

    This position will play a highly visible and strategically critical leadership role, supporting the Company’s R&D efforts to create high value therapeutics to address unmet medical needs

    The role will oversee clinical trials, clinical research, data collection, patient safety, and interpretation activities for the Clinical Development function

    The role will play an important role in determining OnCusp’s oncology portfolio, including in in-licensing and due diligence activities. They will lead interactions with external stakeholders including CROs, Global Health Authorities, to strategic partners and leading Oncology research centers and KOLs

    The role is specifically responsible for the strategy, design and delivery of the Company’s FIM through PoC development programs. Current and/or future development assets will span both large and small molecules, a wide range of mechanisms of action, as well as liquid and solid tumor targets

    Responsibilities:

    Designing high quality Phase I FIM, Ph. Ib and Ph. II POC clinical protocols and programs, and oversight of statistical analysis and report preparation

    Working extensively with and contributing to the senior leadership team, setting strategy and direction for the Clinical Development function

    Working with relevant internal or external partners to ensure appropriate biomarker, PK/PD measurements, and insightful review of emerging clinical data regularly. They will also validate interpretation of study and program results with KOLs and peer input 

    Collaborating with external experts to drive innovation in early clinical development plans and translational/experimental medicine 

    Recruiting, leading, and mentoring a high-performing internal clinical development function as appropriate. Team to build would include approximately four to six colleagues covering Clinical Scientists, Clinical Operations, and other appropriate functions

    • Identifying academic centers, investigators, and physicians to initiate and/or participate in clinical trials and identify key areas of future research 

    Preparation of study reports, integrated summaries, and responsibility for overseeing/authoring clinical documents and preparation of clinical presentations

    Consulting with scientists to deliver non-clinical packages necessary to support translation into clinical programs

    Leading the analysis of biomarkers for clinical studies by working with relevant functions and CRO as needed

    Supporting regulatory submissions, including INDs, regulatory interactions, writing clinical sections for regulatory response and answers to regulatory queries, and providing clinical representation for key engagements with health care agencies

    Clearly defining study priorities and execution plans, communicating to relevant internal colleagues and external CRO partners

    Helping build a strong portfolio of Oncology assets. Helping drive strategic framework of MOAs and modalities for asset prioritization. Engaging in discussions with pharma and academic partners around in-licensing options. Clinical leadership of in-licensing activities, including due diligence activities

    Monitoring, editing, approving, and updating clinical monitoring plans. Developing SAE reporting in conjunction with and directing CRO partner’s clinical monitoring activities. Taking accountability for effective clinical monitoring planning

    Reviewing safety reports/data during study conduct. Providing and documenting oversight of clinical monitoring activities. Reviewing, overseeing creation of patient narratives. Defining product surveillance plans and interpretations, e.g., language for Investigation Brochure. Documenting ongoing Medical Monitor review of data for safety and quality

    Developing and implementing methods and procedures for monitoring clinical research projects and delivering scientific presentations to individuals and groups of strategic importance to the Company

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

    Forecasting and executing on departmental budget and financial reporting

    Ensuring that clinical trials are GCP compliant, and all applicable regulatory requirements, standard operating procedures, and other quality standards are adhered to

    Qualifications:

    MD, preferably with Board certification in Hematology/Oncology sub-specialties

    PhD with strong/relevant early clinical development experience may be considered

    Fluency in English mandatory; Chinese language skills a strong advantage

    10+ years of hands-on Clinical Development experience and a successful track record of leadership in the biotechnology/ pharmaceutical industry

    Oncology expertise mandatory (at least 5 years in oncology). Immuno-oncology experience a bonus 

    Extensive knowledge of Oncology drug development processes. Successful track record of designing and leading early clinical development plans to advance programs from pre-clinical to early-to-mid stage development

    Experience with a broad range of MoAs and multiple tumor targets

    Strong working knowledge of biomarker development to support clinical assets

    Thorough understanding of Health Authority regulatory processes and prior success contributing to successful Oncology submissions

    Experienced with Due Diligence of in-licensed assets

    Successful track record of hiring, training, exceptional people and motivating internal and external teams to the highest level of performance

    Knowledge of effective competitive development strategies and in-depth understanding of the Oncology clinical development landscape

    Experience leading in a line management role, as well as influencing in a matrix, team environment

    Highly experienced with state-of-the-art systems and processes that exist in major biopharmaceutical companies while also having shown ability to operate effectively in the fast-paced environment that prevails within a young, nimble biotechnology company

    Proven track record in managing external relationships with a wide diversity of stakeholders – both internal and external – ranging from CROs, KOLs, academics, regulators, Board members, financial analysts to senior executives

    Proven ability to “connect the dots” between research, development and commercial viewpoints, and ability to develop robust clinical development strategies that take market trends and competitive environments into consideration

    Track record of innovative, creative, and practical approaches to drug development

    Strategic insight combined with a hands-on approach and the attitude that no job is too big or too small

    An individual who thrives on direct accountability for driving clinical development programs 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

    Understanding of challenges, quick to spot opportunities, able to clearly articulate value of opportunities for key stakeholders

    A track record of effectively leading performance-focused teams, collectively accountable for meeting agreed objectives, and focused on performance management and talent development. A leader by influence as well as authority with the experience of building on existing excellence and attracting talent from the outside

    An inspiring natural leader. The VPCD will project credibility, gravitas, collaboration, and influence to interact with the most senior levels of any organization, in particular with existing or potential strategic partners

    A positive “can-do” attitude. Highly developed people skills, including development and mentoring of staff. 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 building a great team, delivering great results, and not concerned about the “trappings” of a senior level appointment

  • Director / Senior Director, Biologics Scientific Lead

    Jun 30, 2021
    • 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