北京招聘

Key Responsibilities

• Work as scientific leader in clinical trials, co-ordinate clinical projects with internal clinical operation team and external CROs to ensure that all clinical trials are conducted in compliance with GCP guidelines, include but not limited to
• Contribute on Target Product Profile (TPP) and Clinical Develop Plan (CDP)
• Develop and/or review of protocol, amendments, investigator brochure (IB), Informed Consent Form (ICF), Case Report Form (CRF), Statistical Analysis Plan (SAP), etc
• Support investigator/site selection and feasibility assessments, and initial medical discussions with investigators
• If necessary, provide medical training to Study Team members and site staffs
• If necessary, review statistical tables, identify additional analyses, interpret clinical data, prepare and/or review Clinical Study Report (CSR)
• Prepare the medical section of briefing documents for discussions/meetings with regulatory authorities
• Develop responses to study-specific medical issues that may be raised by regulatory agencies
• Act as a medical contact person for external Medical Experts to establish strong advisory boards and expert panels
• Support regulatory activities, such as Package Insert (PI)/label, CTA/NDA files, etc, when necessary
• Provide PV support
• Provide medical assessment on new assets (from both disease and product levels), support business development activities such as in- and out- licensing activities.
• Develop medical plan for key products, and provide medical contributions in developing and implementing marketing strategy/marketing activities, including new product launch
• Manage Phase IV, post-marketing surveillance study and IIS
• Serve as medical/technical resource for scientific education and training to internal and external customers. Represent company at Congresses and Symposia, working with marketing on local Congresses and Symposia. Support the development of effective patient medical education and interaction programs, together with regional and country organization
• Review and approve local promotional materials, verifying the medical accuracy of all claims
• Response to medical enquires from both the internal and external customers

Experience

• Medical background, Master or Doctor Degree, dermatology background is preferred.
• At least 2 years clinical practice.
• At least 8 years medical experience in multinational pharmaceutical companies. Familiar with the relevant regulations, with experience in clinical trials
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Competencies

• Proficiency in both oral and written English.
• Good communication skill, ability to liaise with different function involved: MA, RA and MKT & sales team, etc.
• Good capability of strategic and analytical thinking.
• Proactive planning and result oriented.
• Broad medical knowledge and good understanding about pharmaceutical business.
• Good interpersonal communication skills.

科笛生物医药（上海）有限公司（英文名Cutia Therapeutics (Shanghai) Co., Ltd）是一家总部位于中国上海的初创公司。科笛生物致力于为中国皮肤科患者寻求更好的治疗方案。把安全，有效，可承受的国内外皮肤病治疗药物提供给亟需的患者。
目前，该公司已经建立了从研发到临床，再到注册的经验丰富的团队。与此同时，公司正在通过内部研发和外部联盟的方式来构建公司产品线，惠及更多患者。