Vice President - Medical Affairs

China, Shanghai, Shanghai

10 Reasons That You Cannot Miss This Job:

  • You are joining the world’s largest biotech company and the global leader in cancer treatments.
  • You are joining a company that has one of the highest R&D investments in the world across all industries with a robust product pipeline. Multiple product launches are coming soon across diverse therapeutic areas including Oncology & Hemophilia.
  • You are joining a company that has a strong purpose to prolong and improve the quality of patients’ lives.
  • You are joining a family owned company that is over 100 years old. You will see long term commitment to China from top management and benefit from being part of a market that has the full value chain from early research and development, to manufacturing and commercial operations.
  • You are joining one of the world’s best employers who is recognized by multiple authorities and institutes across the world as a sustainable, ethical company.
  • In this role, you would have chance to report to a leader who is visionary and people oriented with high integrity and a strong sense of values .  She has a diverse career across multiple countries and is a strong developer of people.
  • You would also join a great leadership team that is comprised of some of the  top elites in the industry.
  • In this role, you would be the leader, mentor, and inspirer of a highly engaged team composed of 230+ medical professionals with a high engagement level and a desire to make a big impact for Chinese patients.
  • In this role, you would be a core member of Roche’s Global Medical Committee. Your voice would be highly valued, and your insight would not only impact local medical strategy but also Roche’s long term global medical strategy.
  • In this role, you would have opportunity to pioneer and lead the upcoming medical-driven era in the industry and shape the new Pharma landscape in China together with customers

 

Primary Purpose of Job (Job Summary) 主要工作目标(岗位简介):

  • Provides strategic direction and leadership to the local Medical Department
  • Contributes to the leadership and management of the Affiliate by providing strong functional expertise and ensuring it adheres to the highest scientific and ethical standards and fulfils all regulatory and compliance requirements
  • Contributes to the collective Medical leadership of the Company and to the appropriate use of Roche products
  • Represents Roche medical authority with key external stakeholders

 

Accountable for:

  • Medical strategy for the Affiliate
  • Evidence generation activities
  • Scientific collaborations and knowledge-sharing, incl. medical information, medical education and publications
  • Strategic partnerships, incl. TAE collaboration, health authority interactions, Patient organizations, Payers
  • Clinical Operations (Phase IV study and Investigator Initiated Study)
  • Pharmacovigilance

Principle Roles & Responsibilities / Accountabilities 主要职责/责任 (Major functions of the position) (职位的首要职能)

People Leadership / Management:

  • Develops and leads a highly motivated and effective team with a performance-led culture, strive for excellence and strong focus on cross-functional collaboration
  • Manages the budget/resources and ensures prioritization of investments to meet the medical objectives (short and long-term)
  • Builds strong relationships and ensures good collaboration and communication between Medical and other affiliate, regional and global functions

 

Medical strategy and tactics:

  • Provides strategic guidance and scientific leadership, defines and executes the affiliate long-term vision, including strategic partnerships
  • Shapes development and delivery of affiliate medical plans, in alignment with Lifecycle plans. Aligns medical strategy development across functions, locally and globally. Collaborates with regions to evolve medical strategy
  • Strategizes optimal mix of evidence generation investment and other medical activities
  • Ensures strategic partnerships with TAEs, scientific institutions/societies, patient associations, cooperatives groups, health authorities and payers to support patient access and enable optimal use of Roche products

Evidence generation activities:

  • Is accountable for affiliate evidence generation portfolio management needed to enhance product knowledge and anticipate/support patient access according to the local needs and in line with global strategy
  • Oversees the development of medically sound, feasible affiliate studies which are approved and executed in compliance with all policies and regulations
  • Ensures the highest standards of clinical trial conduct, disclosure and data transparency in collaboration with Clinical Operations

 

Scientific communications (SC) and Medical Information:

  • Builds effective collaborations with external stakeholders and ensures integration of insights to support the medical strategy, including patient access
  • Ensures medical and product information is provided in compliance with SOPs, local requirements and that all data used in the provision of Medical information are accurate and meet the needs of internal and external customers

 

Compliance and Training:

  • Is accountable to set the local quality management system for the medical department. Ensures that all medical activities comply with Roche policies/SOPs and local regulations
  • Evaluates and anticipates quality and compliance related risks. Provides clear guidance on appropriate actions
  • Ensures that Medical Affairs staff is fully trained and compliant with Roche SOPs and regulations. Oversees medical review and approval of promotional materials. Ensures the accuracy of training material for scientific and product information

 

Drug Safety / Pharmacovigilance:

  • Ensures that processing and reporting of safety information is conducted in compliance with Roche SOPs and local regulatory requirements
  • Ensures oversight of the safety of local clinical activities

 

Regulatory Affairs & Health Economics / Market Access:

  • Provide timely support to RA and CAMAC
  • To manage effective relationship with Regulatory, Reimbursement and other health authorities to achieve registration of and access to products and approval of clinical trial applications; to anticipate clinical/RWD data needed to accelerate patient access. Ensures clinical value evidence and medical contribution are provided to support HTA submissions