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Principle Roles & Responsibilities / Accountabilities
(Major functions of the position)
Medical Strategy and planning
Ø Accountable for development, delivery and maintenance of DA medical strategy
– Drive the synthesis and translation of complex scientific data/clinical situations into strategy and solutions to optimize care for patients
– Creates and executes long term medical affairs DA strategy
– Ultimately accountable to provide strategic perspective based on a deep understanding of clinical decision-making to inform decisions about unmet medical needs and the impact of clinical data on clinical practice pattern
Ø Accountable for team development, delivery and maintenance of strategically aligned Medical Plans (on-market & in portfolio) within assigned DA(s)
– Leads Country Medical Managers and Medical Science Manager(MSM) Leaders working on the same product or DA to develop and execute annual medical plan
– Ensure medical plan is to aligned with global medical plan, DA strategy and brand strategy
– Leads Country Medical Managers to periodical update medical plan to reflect the change of the competitive landscape and critical business strategy change if appropriate
– On time, quality and within budget delivery of the medical plan, either directly or through team member(s)
Ø Supervises team to actively build up internal cross-functional strategic partnership for assigned DA(s), also including global networking
– Acts as point of contact for any strategic discussion on the assigned DA(s)
– Partner effectively across the medical and strategy network, within China cross functions(Access, CPS, PD China, CiCOR) and with global(PD, PDMA & GPS) colleagues to create and deliver options to support short and long-term goals on the assigned DA(s)
– Upgrades the influence level to the global IMT (International Medical Team)
Ø Accountable for the scientific & strategic leadership for all other key medical activities for the assigned DA(s), including medical information service, epidemiology/outcome research, medical education, medical publications, pharmacovigilance, and biomarker science, etc. to ensure alignment of the overall medical strategy and optimal execution of the medical plan
Ø Accountable for the medical and scientific support provided to the commercial activities for the product(s) within assigned DA(s), including medical input in the marketing strategy, external professional interaction, sales training, promotional material generation
Evidence generation
Ø Medical/scientific accountability for formation and execution of high quality clinical studies and other sources of evidence generation (e.g. RWD ), including but not limited to defining study concepts/synopses, protocol development, medical monitoring, final study reports and preparation of data for publication of study results
Ø Accountable for close collaboration with regulatory and development teams to provide unmet medical needs assessment and product value proposition to ensure an optimal local registration strategy for the new product and/or new indication(s)
Ø Accountable for identifies potential medical interest for line extensions according to the scientific rationale and the understanding of the actual and anticipated future medical practice in key markets
Knowledge exchange/Data communication
Ø Accountable for full execution of MSM action plan
– Leads MSM Leaders to ensure the execution of MSM action plans to fulfill the scientific communication objectives
– Brings medical insights from external stakeholders to internal medical and product teams timely and accurately, to help shape strategic planning
Ø Ensures that medical expertise and scientific data is provided to other stakeholders such as Regulatory, Drug Safety, Health Economics, and Public Policy as appropriate to support proper product labeling, reimbursement and funding.
Ø Leads medical events such as advisory boards and Roche initiated medical education events, in charge of coordinating activities involving TAEs, Societies and Collaborative Group
TAE engagement
Ø Oversight of TAE management strategy, and engagement plan within DA and MSM execution to deliver DA strategy
– Leads MSM Leaders and Country Medical Managers to develop TAE management strategy and engagement plan and ensure the alignment with DA strategy
– Oversees TAE management in the field by building up the capability and capacity of DA team to ensure high quality scientific engagement
Ø Develops and maintains a network of opinion leaders and experts in the assigned DA in order to maintain and reinforce the scientific leadership of the Company
People Leadership
Ø Builds up the capability and capacity of DA team members to ensure the resource and skill set needed for a high quality medical deliverables.
Ø Motivates all team member(s) to work towards the aligned goal, provide coaching and support to the team member(s), responsible for team member recruitment and career development
– Inspires and motivates a positive spirit of teamwork by active, open and constructive communications
– Actively promote an inclusive environment. Coaches and supports individual subordinate team members for desired performance and career development
– Oversees the development and implementation of training plans for assigned DA team
– Manages the DA team budget, including review and approval of expense reports
Compliance
Ø Strict adherence to the company’s corporate policies, SOP and local regulations for all initiatives for assigned DA(s)
– Ensures appropriate scientific and medical compliance, governance and risk management with the framework of optimized patient centric risk/benefit in the responsible DA
– Contributes to establishing appropriate policies and standards for all medical activities(e.g. studies, publications, registries, TAE collaborations)
– Ensures all medical initiatives implemented strictly adhere to Roche SOPs/policies and local regulations.
– Champion the implementation of medical compliance with high ethics and integrity
Ultimately accountable for the final assessment of benefit/risk and safety for patients, including medical monitor activities, product, clinical trial, and promotional material where patient benefit/risk assessment is needed
Qualification and Experience
Education/Qualifications
- Master in Clinical Medicine, Pharma or Science required, MD strongly preferred
- > 3 years’ clinical experience with specialty in the relevant therapeutic area
- > 10 years’ experience in medical affairs or product development in multinational pharmaceutical company
Leadership Competencies
- Experienced strategic thinking and planning skills.
- Demonstrated ability in cross-functional leadership
- Proven experiences in people and budget management in relevant pharmaceutical organizations.
- At least 3 years of managerial experience in the Medical Affairs is required
Job Required Competencies
- Strong academic expertise in the relevant Disease Area
- Strong knowledge of the overall drug development process and medical activities before and after launch
- Demonstrated understanding of principles and techniques of evidence generation, data analysis/ interpretation & clinical relevance
- Demonstrated strong work ethic, and proven track record of delivering high quality within timelines
- Scientific credibility and enterprise thinking on how medical affairs impacts the broader organization and ability to provide proactive solutions to complex enterprise needs
- Superb collaboration, influencing, and communication skills in developing strong partnerships with cross-functional commercial, development, and global peers
- Demonstrated evidence of successfully achieving results, managing a high functioning team
that delivers on their accountabilities, and mentoring and developing emerging talents
Travel Frequency
25% - 50%
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.