Emerging Portfolio Medical Lead
5 개월전에
Job Responsibilities
Medical expert on clinical development and local commercialization decision
- Be in charge of newly introducing disease area (across CVRM/R&I/V&I/Rare disease/Oncology) which AZ Korea medical affairs do not yet have coverage of the disease area.
- Continuously acquire and update necessary scientific knowledge on new therapeutic area and relevant compounds.
- Collaborate with Oncology/ Biopharm SMM & Alexion COM by providing medical input into the study protocol/feasibility/site selection and by contributing scientific presentation and site visit during conducting clinical trials
- Collect medical information on the local treatment landscape of the new indication.
- Explore real-world data and real-world evidence (local patient demographics, prevalence of specific biomarker, medical unmet needs, etc) from publication.
- Collaborate with commercial, regulatory and market access to identify data requirements to registration & access/reimbursement
- Develop strategy of local RWD/RWE generation.
- Generate real-world data by analyzing medical database or collaborating with medical experts, medical association, data analytics company.
- Build external collaborations ( relationships with KEEs, investigators, scientific associations, digital therapeutics/diagnostics partners) and seek and incorporate external advice
- Collaborate with regulatory affairs and NPP manager by developing medical strategies to support commercialization decision and the pre-launch activity.
- Provide local medical expertise to regional/global team.
- Provide effective medical/clinical trainings (basic science and disease knowledge, drug profile, clinical data) to internal colleagues
- Anticipate future trends and needs in the marketplace
Governance and ensuring overall adherence to processes and regulation (include but not limit to patient safety, clinical trials, promotional activities, etc …)
- Accountable for ensuring Promotional Compliance: Provide medical input to the creation, development and agreement of promotional material and ensure all material is in line with internal SOPs and meets IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) code
- Ensure that Pharmacovigilance activities meet internal SOP and local regulations
- Ensure clinical studies are carried out in accordance with AZ SOPs and cGCP. Support Clinical team to select appropriate investigators and sites optimizing quality, delivery and commercial benefit
- Aligns with the values and vision of AZ
- Actively participate/encourage the development of the AZ culture
- Ensures compliance with AZ code of conduct, Corporate Governance, Audits requirement, guidelines, codes, policies and procedures
- Ensures that company confidentiality is maintained ( intellectual property, product, strategic and salary information)
- Discloses potential breach of codes or conducts
Personal development
- Develop functional capability in the role
- Communicate, develop and role model of AZ culture and AZ Values & Behaviours
- Develop individual and team accountability
- Identify areas for self-development and discuss developmental needs with line manager (experiential learning, coaching/networking/relationship-based learning and classroom training)
- Attend & actively participate in learning programmes, training, projects and meetings (where needed)
Typical Accountabilities
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
Functional Capabilities
- Scientific knowledge
- Communication skills
- Planning & Organization
- Strategic Partnering
Essential Qualification
- Certified medical doctor or MSc/PhD in bioscience
- Medical/Scientific knowledge and appropriate experience in the clinical practice, medical affairs or clinical operations (more than 7 years)
- Ability to collaborate and lead strategy with internal stakeholders
- Excellent presentation skills
- Ability to collaborate with various stakeholders
- Ability to travel
- Fluency in English is required
Desired skills or requirements
- A medical degree with specialization
- Understanding of multiple aspects within clinical development and medical affairs
- Extensive knowledge of the latest technical and regulatory developments
- Experienced medical Leader, with track record of shaping launch strategies, driving successful launch readiness and realizing market shaping initiatives
- In-depth scientific and clinical practice understanding / direct experience with CVRM, R&I, ONCO and/or Rare disease
※ Global Career Level can be changed depending on candidate's experiences.
Date Posted
21-5월-2024Closing Date
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