1. Clinical Program Manager (ideally based in greater Boston, MA, USA area)
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- Bruce Porter
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1 Livzon Mabpharm, Inc ( 珠海丽珠单抗生物技术有限公司 ) a development stage biotech company, was jointly founded by two publically traded companies (Livzon Pharmaceuticals Group and JointCare). It focuses on the development, production and sales of biologics (both biosimilars and innovative drugs). It is located in Zhuhai city, a beautiful coastal city rated as the most livable city in China. We are positioned to become a leader in the biopharmaceutical industry in China and a key player in the global market The Livzon Pharmaceuticals Group ( 丽珠医药集团 )is a leading China based company, publically traded Hong Kong and China. It has 12 sister companies with approximately 6000 FTE and annual revenue of over $1 billion US dollars. In China, we have 120 marketed products for the treatment of gastrointestinal disease, cardio-cerebral-vascular disease, anti-infectives, and reproductive health, including Chinese traditional medicines. We are expanding our global capabilities to serve patients and caregivers outside of China. Benefits: Livzon Mabpharm offers competitive salaries and a great benefits package including the option to be paid in US dollars, flexibility and travel assistance to and from China, an incentive bonus plan, and employee health insurance and retirement plans. Livzon Mabpharm is seeking to hire for the following senior level position. Interested candidates should please contact Robert Mattaliano (bob.mattaliano@livzonmabpharmusa.com) 1. Clinical Program Manager (ideally based in greater Boston, MA, USA area) The Livzon Mabpharm USA Clinical Program Manager provides comprehensive project management for the team to ensure alignment and execution of clinical research, development, medical, and commercial strategic and operational objectives. The CPM serves as the operational leader ensuring all cross functional deliverables are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The CPM s responsibilities encompass clinical trial strategic and scenario planning, CRO interactions, program and submission execution, resource management, risk management, and information and communication management. The CPM will regularly make presentations to senior staff members or corporate advisors
2 The successful candidate will also assist in operational functions related to management of the US based Mabpharm subsidiary Job Skill and Requirements: Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree (PhD, PharmD, MBA) desirable. Mastery of project management skills. Minimum of 5 years pharmaceutical clinical trial management experience with focus in development of drugs/biologics, including biosimilars. Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable. Strong track record of performance on cross-functional teams and results achieved through effective implementation of project management methodology, tools, and techniques. Extensive knowledge and experience in drug development, clinical research, medical, and/or commercial disciplines with proven performance in clinical trial execution and project delivery. Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills. Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders Proven ability to interact effectively across multiple functional levels and projects. Demonstrated ability to utilize project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis). Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines. Experience working with contract research organizations, budget management, and related areas. Knowledge of medical and commercial issues that drive clinical development and life cycle management. Proven ability to succeed in a challenging and global matrix team environment. Excellent verbal and written English communication skills. Ability to travel internationally 2. Director, Regulatory Affairs (based in greater Boston, MA, USA area)
3 The Livzon Mabpharm USA Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategies for US-related regulatory functions. This position coordinates planning, working with multiple project teams in the US and Asia and developing regulatory strategies to ensure achievement of corporate regulatory goals while acting as the US based liaison to the US FDA. Principle Duties and Responsibilities: Develop and implement regulatory strategy and manage those systems and programs in order to meet Livzon Mabpharm USA goals and objectives Prepare and review FDA applications and other regulatory documents related to biologics including INDs, and NDAs Review and advise on product registration and licensing requirements Review and interpret US regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through Livzon Mabpharm policies and procedures Review all product labeling and marketing materials to ensure compliance with US regulatory requirements Ensure that the US Regulatory function interfaces with key functional groups (R&D, Manufacturing, Sales, Marketing, Quality Assurance and Field Clinical Groups) to drive company-wide or cross-departmental initiatives Participate in the short and long range planning of new product opportunities Provide management-level representation during internal and external cgcp audits Oversees the Regulatory Department SOP review and development, and associated requirements Regularly make presentations to senior staff members or corporate advisors Procure and oversee outside vendors and consultants, as required Establish and maintain a professional and credible image with regulatory authorities, consultants, vendors and co-workers Job Skills and Requirements: Bachelor degree in a life sciences discipline; an advanced degree is preferred Regulatory Affairs Certification preferred Minimum 8 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics, including biosimilars. Direct experience in preparation, submission and lifecycle management of investigational/marketing applications in ectd format, including as primary Regulatory author Experience negotiating and directly interfacing with US regulatory authorities
4 In depth knowledge of GXP/ICH guidelines and regulations Ability to work in a dynamic environment with a high degree of flexibility Proven ability to interact effectively across multiple functional groups and projects Excellent prioritization and organizational, and problem solving skills Positive flexible outlook Excellent verbal and written English and Chinese communication skills Ability to travel internationally 3. USA East Director Business Development (based in greater Boston, MA, USA area) The Livzon Mabpharm USA East Director of Business Development will identify in-licensing opportunities, acquisitions and out-licensing opportunities that support our strategic objectives, with an emphasis on serving the eastern USA area. This will include structuring, negotiation of terms or licenses, strategic alliances and acquisitions. The Director of Business Development will also help develop and implement processes and procedures designed to create a cross functional deal process within the Livzon Mabpharm. Principle Duties and Responsibilities: Develop and coordinate presentations to potential partners Lead due diligence activities and interactions with potential partners throughout the deal process. Manage development of a business case and financial model with other Livzon functions Manage the overall assessment of Livzon USA transaction. Prepare and deliver presentations to Livzon Management and advisors integrating and summarizing scientific, clinical, financial, and market information. Assist in the structuring and negotiating of licensing and acquisition agreements with potential business partners. Devise and implement cross functional deal processes and procedures. Job Skills and Requirements: MBA, or relevant business experience (pharmaceutical, biotech, venture capital, investment banking) with 5-10 years of business development experience. Strong interpersonal skills, ability to persuade and motivate others. Ability to synthesize and summarize a complex set of facts within the broader strategic context. Strong analytical skills and the ability to assess detailed models and analytics.
5 Strong multi-project management skills Able to build and maintain contacts with potential partner companies Ability to work with a high degree of flexibility Excellent prioritization and organizational skills and problem solving skills Excellent verbal and written communication skills Ability to travel internationally 4. Vice President, Biologics Manufacturing Site Engineering (based in Zhuhai, China) The Vice President for Biologics Manufacturing Site Engineering leads the development and execution of the capital project portfolio to enable commercial manufacturing of biopharmaceutical products, including recombinant proteins and monoclonal antibodies. The position is responsible for managing project managers and contractors involved in the execution of the capital projects, as well as plant engineering staff (steam, air, water, electrical, EHS, etc.) that support biologics commercial manufacturing operations. Principle Duties and Responsibilities: Capital Project Management. Lead the overall development and implementation of state of the art design and engineering systems for the construction of a modern biologics manufacturing facility involving cell culture, protein purification, fill & finish, lyophilization, etc. Capital project management entails all phases including project scope development, multiple phases of design, securing of all permits, construction management and commissioning and qualification. Manage the development and administration of capital and expense budgets for the capital project. Coordination, Collaboration & Communication. Facilitate specific sub-projects in collaboration with other functional groups (such as Process Development, Quality, Supply Chain, etc.) in the review of engineering drawings and specifications to ensure consistent functions and forms. Regulatory Compliance. Interface with regulatory authorities (including local and international pharmaceutical regulators, environmental, health and safety authorities, etc.). Be accountable for non-conformance investigation with appropriate CAPA implementation. Customer Service. Build and sustain strong relationships with internal stakeholders (including Manufacturing, Process Development, Quality, EHS, Facilities & Engineering, etc.), as well as external stakeholders (such as local communities and government agencies) to ensure achievement of the overall business objectives.
6 Leadership Expectations. The work at this level is characterized by freedom from immediate supervisory control on routine and regular assignments. As such, the VP is expected to carry out assignments without detailed instructions. The ability to recognize critical issues and communicate vertically and horizontally is essential. Job Skills and Requirements: Specific Skills and Knowledge A minimum 15 years of experience in facility and engineering services in pharmaceutical/biopharmaceutical manufacturing environment. Mastery of engineering principles especially in relation to biopharmaceutical processes including cell culture, protein purification, fill & finish, and lyophilization. Excellent knowledge of various operating systems under cgmp regulations, such as clean room operations, clean utility systems, cold chain management, access controls, etc. Familiarity with the current FDA/EMA/CFDA regulations, fundamental principles and industry trends. Superior verbal and written communication skills. Education, Licenses & Certifications Bachelor s degree in Mechanical, Chemical, or Industrial Engineering or any other relevant disciplines (Master s degree is preferred but not required). Prior direct participation in capital project management is essential (PMP certification is preferred but not required). Work Flexibility This position is located in Zhuhai, Guangdong, China and may require approximately 25% of travel. Work environment for the job include office space, lab space, inside work, outside work, working alone, working with and around others. Organizational Responsibilities This position reports to the head of manufacturing operations. Supervisory responsibilities include the project managers, site Facility & Engineering staff, plant engineers, and contractors on site.
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