• 招聘类型：社招
• 工作性质：全职

职位描述

Responsibilities:

The position is required to perform the following roles:

Core Roles

Country/Region Leadership

• Responsible for the China clinical development strategy for products falling within the therapeutic area/tumour type including clinical development plan, and LCM plan for compounds at different stages in the disease areas.
• Leads local development teams for the disease area and/or products and key representative for R&D China on global development and/or study teams
• Responsible for medical oversight of local clinical studies in China and ensure medical review of clinical data and safety for patients in ongoing studies
• Strategic and scientific input into regulatory documents for new drug and clinical trial application in China in close collaboration with GRS
• Oversees execution of local clinical studies with regard to medical data review, scientific interaction with key external clinical experts including organisation of advisory boards, investigator meeting in conjunction with RCO and global development teams
• Ensure local activities are in line with global strategies and global strategies aligned with local needs in close collaboration with other local functions including commercial
• Liaise with Head of Development China to manage all issues to ensure studies are designed and conducted in alignment with scientific quality, and in compliance with our SOPs and regulatory requirements
• Responsible for scientific content of key documents such as clinical study reports and publication of local data
• Build country reputation and visibility at the international level by managing the timely execution of trials and other clinical activities
• Contribute to priority set-up and budgeting for trials in own country with appropriate input from Global/Regional Medical teams

People Performance Developer

• Manage performance of direct reports including providing appropriate and timely feedback and conducting annual and mid-term performance reviews with direct reports
• Contribute to talent assessments, development and retention
• Translate business objectives into individual goals for direct reports and help direct reports develop a Development Plan and identify career development opportunities
• Coach and mentor all direct reports
• Assess and identify skills/knowledge gaps among direct reports and work with Head Development China to develop approaches of fulfilling the gaps
• Ensure new staff attend induction programs, and that direct reports have access to continuous learning and development opportunities
• Promote a culture of innovation, constructive challenge, team spirit and accountability within China Clinical Research Team that is based on ensuring the well-being of patients

Shaper of Global Lifecycle Management Plans

• Identify potential lifecycle extension opportunities through discussion with External Experts
• Collaborate with medical affairs leaders and BU Managers to identify and assess lifecycle management opportunities for the country. Provide this information to Global/Regional Medical team for communication to Global development Teams

Disease Area Reference Point

• Continuously update knowledge of therapeutic area DA, patient treatment trends and scientific activities
• Provide timely and informative responses to scientific queries from external customers including regulatory authorities and internal partners, which accurately reflect scientific data
• Effectively communicate medical benefits for all products within the therapeutic area in an accurate, transparent, balanced, and objective manner

Compliance

• Ensure compliance with SOPs, GCP, ICH and regulatory requirements, as well as with legal and ethical standards
• Provide appropriate medical representation for the management of major issues such as product withdrawals or major safety issues
• Act as a role model who demonstrates consistent ethical and professional behaviour
• Ensure all DASs are up-to-date with required training
• Alert management – in particular Legal and/or the Compliance Officer - to potential compliance issues

Pharmacovigilance and medical oversight

• Ensure that direct reports have the required training and skills to identify and report Adverse Events and assess the causality of PV cases
• Contribute to managing external communication when significant safety issues arise, with the well-being of patients being the ultimate goal
• Responsible for medical oversight of local clinical studies in China and ensure medical review of clinical data and safety for patients in ongoing studies

Clinical Trial/ Survey Manager

• Monitor progress of trials and surveys, ensure they meet planned timelines, and act decisively to address slippages

External Expert Manager

• Maintain direct contact with external clinical experts to gather insights and input on treatments/DA and develop strong peer-to-peer scientific partnerships with them
• Support direct reports in developing strong networks with clinical external experts
• Anticipate customers’ needs and countries changes with impact in disease treatment patterns and propose strategies

Contributor to Brand Plans & Strategies

• Support Developing the therapeutic area Medical Plan in close collaboration with medical affairs
• Ensure direct reports effectively leverage insights from external expert relationships and from reading publications and turn scientific data into compelling Brand messages which meet Regulatory requirements and meet patients’ needs
• Input into Brands Plans and Strategies based on analysis of medical literature and other information
• Promote effective working relationships with Medical and Marketing

Expert Contributor to Internal Partners (Medical, Marketing, Regulatory, OR, PV and Legal Counsel)

• Provide scientific support to Medical, Marketing, Regulatory, Outcomes Research, Pharmacovigilance and Legal Counsel
• Promote effective working relationships with internal partners
• Identify formulary specific requirements and Local Market Access needs and address them with the support of GEOR and Global/Regional Medical team

任职条件

Requirements:

• Medical doctor (physician) with significant experience in the relevant therapeutic area in the pharmaceutical industry (10-15 years)
• Extensive experience in designing and managing clinical trials across different phases of development, Extensive experience working in cross-functional teams
• Track record in effectively managing risk and compliance
• Solid track record in writing quality scientific publications and representing BMS at international congresses
• Building strong relationships with External Experts within DA (virology)
• Significant line management experience including performance management and people development skills
• Managing complex trials across multiple countries
• Strong verbal and written communication skills
• Complete knowledge of country regulations, BMS SOPs, GCPs and ICH
• Solid understanding of medical oversight of clinical studies and statistical methods in clinical trials
• In-depth understanding of different communication techniques
• Leading-edge approaches to capturing market insight
• Innovative approaches to managing customer and internal partners
• ASMART principles in goal setting
• Matrix management principles
• Line management experience

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要