RESPONSIBILITIES:

• Serve as internal global lead and work closely with senior consultants and agencies for all corporate finance and accounting responsibilities.

• Lead all budgeting and forecasting initiatives, including monthly and quarterly reporting of financial results for management and department heads.

• Assist with developing dashboards and advanced analytics to support decision making; including quarterly and annually reporting packages, and for presentations to the Senior Executive Team and Board of Directors.

• Manage annual tax filing and reporting

• Engage with accounting firms and manage auditing process 

• Continuously develop and/or optimize processes and SOPs to increase efficiency, accuracy, scalability and compliance.

• Manage timely external and internal payments and processes. Review and assess proposed financial terms and costs for vendor contracts and support contract negotiations to ensure sound financial decisions.

• As internal point of contact, lead cash management and investment together with external advisors

• A hands-on approach to working with R&D groups and other stakeholders across the organization in addressing challenges and developing solutions.

• Manage a junior team member based in China

Qualifications:

• Bachelor’s Degree or equivalent required. 

• Professional designation (CPA, MBA or CFA) preferred. 

• Minimum of 10 years’ related finance experience. 

• Fluent in English. Bilingual in English and Chinese preferred

• Biotech experience in a development-stage company or pharmaceutical experience is required. 

• Exceptional financial modelling and analysis skills with strong attention to detail and accuracy. 

• Excellent oral and written communication, leadership, and interpersonal skills as well as the ability to build credibility and trust inside the Company. 

• Excellent analytical and problem-solving skills with sound business judgement, with an ability to constructively challenge assumptions. 

• Experience with ERP software (e.g. NetSuite) and tools. 

• Excellent organizational skills with the ability to manage concurrent deliverables and work effectively with minimal direction in a challenging, high performance and changing environment.  

Responsibilities:

• Designing high quality Phase 1a, Ph. Ib and Ph. II clinical protocols and programs, and oversight of statistical analysis and report preparation.

• 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.

• 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 future OnCusp 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. Engaging in discussions with biotech, 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.

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

•  Contributing to due diligence efforts of in-licensing assets.

Qualifications:

Education:

• MD, preferably with Board certification in Hematology/Oncology.

Desired Personal Attributes:

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

• Oncology expertise mandatory (at least 3 years in oncology).

• Extensive knowledge of Oncology drug development processes. Successful track record supporting early clinical trials

• Strong working knowledge of biomarker development to support clinical assets.

• Thorough understanding of Health Authority regulatory processes and prior success contributing to regulatory interactions.

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

•  Experienced with state-of-the-art systems and processes that exist in major biopharmaceutical companies.

•  Ability to adapt, respond, and 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.

• Understand and evaluate the competitive landscape for multiple tumor types. 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.

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

•  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.

• Preferably located in the NYC region; remote work with routine travel to company meetings also acceptable.