職位描述
職位描述：
JOB PURPOSE/ COMPANY RELATIONSHIP The mission of this department is to develop products for patients in the AP region. The role and responsibilities include AP project leadership and/or clinical research leadership AP Project Leadership (AP PL): Be responsible for leading development projects from entry into development to successful approval. He/she will lead a tailored development Project Team to plan and ensure the successful completion of development projects according to rigorous scientific and regulatory standards. Actively directs the project for completion of milestones and actively addresses any deviations from the plan that would trigger review of the project by the appropriate governance committees. In collaboration global project teams or independently for AP only projects with the respective functions, the Project lead facilitates the creation of resource and budget plans for review by goverance committees. Clinical research Leadership: Be responsible for the design and execution of clinical development plans leading to regulatory submissions in AP countries. The position is responsible for high level clinical guidance of the: set-up, implementation, conduct, analysis and reporting of those clinical trials to ensure the ability to file with regulatory authorities KEY ACCOUNTABILITIES: l Clinical Research Leadership: n Be capable of planning and directing a clinical program leading to regional regulatory submissions. This entails writing the clinical part of the AP part of the IDP (integrated development plan), and writing (be the author of) the protocol Extended Synopsis (ES) of the study/ies. n To provide guidance and assist in the conduct of clinical trial programs in the AP region in collaboration with the Clinical Study Director (CSD) and the Clinical Operations Group (CSO). n Serve as medical and scientific expert for the clinical programs, including: u Identify and working with key KOLs and sites in the disease area u The final review of clinical trial data as regards to accuracy, quality. u The collaboration, together with the CSD, with the Pharmacovigilance department in the timely and accurate follow-up of the patient safety (e.g. adverse events) in clinical trials, and the data surveillance plan and the risk management plan, if any is implemented and conducted. u The participation in building and review of the Key Result Memo and of the Clinical Study Report. n Cooperate and participate – clinical part - in the building and writing of AP registration dossier in close relationship with the AP Project Lead(if separate role), Regulatory Affairs, and other key contributors. n Participate in written and oral presentations to experts and investigators, to business partners, to development management and to regulatory bodies involving discussion of the clinical issues relating to the project. l As Project Lead n Project Strategy: u Directs the creation of an AP Integrated Development Plan (IDP) to translate the overall project strategy into an executable development plan. u Leads the implementation of tailored cross-functional Project Team. n Operational Management: u .Manage the Projcet team in order to efficiently and diligently implement the development plan. In collaboration with the Project Manager, monitor, anticipate, and track any deviation from the agreed plan (time, risk, scope). Anticipate risks and if needed contingency planning. Proactively identify potential issues and manage cross-functional and cross-cultural resolution.. u Co-Chair the CTD submission task force. u Represent AP Development and vis a vis Medical & Marketing, Pharma Operations and BUs in the AP region/countries, represent AP Development in the Global Project Team. Proactively identify potential issues and manage cross-functional resolution, as well as all cross-functional team activities. u In close collaboration with the Project Manager and team members, assume responsibility for the preparation and quality of the following documents, e.g. AP part of the Integrated development plan (AP –IDP), Presentation to Management Board, including Position Papers; Project Team Objectives; Executive Summaries and minutes/actions of Project Team meetings. Supervise the completion of clinical overview, clinical-regulatory documents (such as investigator’s brochure, benefit/risk assessment, briefing package for health authorities, etc..). Full director level: proven ability to independently develop above mentioned documents up to a quality ready for management sign-off. DECISION RIGHTS: l Project Lead: n Authority to implement strategy as defined in IDP. n Negotiate resource conflicts with functions. n Implementation of strategic changes / addressing of emergent issues require close interaction with manager/appropriate management committees. n Full director level: upon delegation by management, assume leadership role in critical project-tasks, including key alliance interactions. l Clinical leadership: n Use judgment and expertise in executing agreed strategy. Anticipate significant issues for discussion and resolution by clinical teams or management, as appropriate. PARAMETERS FOR SUCCESS: l Key Metrics n Number of programs through phase transition. NDA submission & approval. l Organizational n Network with internal stakeholders: Therapeutic Area Development Lead, AP Development Head and Global Project Head, Discovery, Preclinical, Regulatory affairs, Quality, Pharmacovigilance, medical and Marketing, BUs and other key R&D departments to provide direction for AP projects and clinical research activities. JOB-HOLDER ENTRY REQUIREMENTS: Education: l Scientific degree (Ph.D.; M.D.; Pharm. D.). MD degree is required for the clinical lead position, prior clinical position as a phycisian is a plus. Certification in relevant medical or scientific specialities is a plus l Other degrees may be acceptable as scientific qualification if supplemented by appropriate, documented on-the-job scientific expertise. Experience & knowledge: l 5+ years in pharmaceutical industry; 3+ years in global/clinical drug development and or equvalent clinical trial expereince; Strong medical background. Ideally with experience in other industry medical functions (medical affairs, clinical operations, safety or translational medicine) l People / Team Management skills: Ability to lead and challenge multifunctional teams; conflict resolution, and ability to facilitate decision-making; ability to conduct effective meetings; ability to work effectively in cross-cultural environments. l Technical Competencies in areas such as: Drug development including experience with clinical projects; project management; scientific knowledge and experience; budget management; resource management; l Operational Competencies: Performance-oriented, and achievement-oriented, audacious; familiar with details of drug development process; analytical and troubleshooting competencies; creativity and common sense; issue and conflict analysis; able to communicate and negotiate across all levels of organization; ability to operate in an international and cross-functional environment; professionalism and demonstrates solidarity with organization and team members; customer focus; interpersonal savvy with respect for people; good communication skills (written and oral). l More specifically from Clinical Research view point: n strong medical background particularly in oncology area as well as a very good understanding of the drug development process and the regulatory framework for clinical trials. n The ability to interpret clinical data accurately is essential. n Strong verbal and written communication skills in English and local language (such as Chinese, Japanese, etc) are required to complement the ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions. n Good knowledge and experience with the process of data collection, management, and analysis are required for direct and indirect management of this process. n Good negotiation and persuasion skills are important.
