加入我们

昂阔医药致力于将其日益扩大的管线中的临床前候选药物转化为可以为全球患者带来帮助和希望的创新疗法。

我们的成功与优秀的团队密不可分,期待更多充满热情的优秀人才加入团队。我们拥有中西融合的企业文化,在纽约和上海两地均设有办公室。通过发放股票期权,我们与每位为公司作出贡献的员工共享成功果实。

工作机会

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

    Dec 17, 2021
    • Division: Manager to Director, Project Management (preclinical)
    • 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.

  • Senior Director to Vice President, CMC

    Oct 27, 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

  • Manager to Director, Project Management (preclinical)

    Oct 27, 2021
    • Division: Manager to Director, Project Management (preclinical)
    • 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

    Oct 27, 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

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

    Oct 27, 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