Emerging Portfolio Medical Lead

[Job description]

An internal and external facing medical role that provides medical and clinical expertise in emerging portfolio areas and builds AZ scientific leadership. Responsible for strategic direction accelerating Emerging Portfolio incorporation through establishing partnership among relevant cross-functions on the roll-out of New Molecular Entities (NMEs) and Line Extensions (LEs) across all therapeutic areas including CVRM/R&I/V&I/Rare disease/Oncology. Collaborate with Oncology/ Biopharm SMM & Alexion COM to support conducting clinical trials by providing medical input. Collaborate with the Regulatory Affairs and Commercial team on commercialization decision.

[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 (e.g. 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 code

• If appropriate to market, 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 optimising 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 (i.e. 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 AZ culture and AZ Values & Behaviours

• Develop individual and team accountability

• Identify areas for self-development and discuss developmental needs with line manager using the 70-20-10 principle (experiential learning, coaching/networking/relationship-based learning and class room 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.

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.

[Education, Qualifications, Skills and Experience]

- Essential

• Master or Doctoral level degree (MD, PharmD or PhD) in a medical/scientific discipline

• Medical/Scientific knowledge and appropriate experience in the clinical practice, medical affairs and/or clinical operations (more than 7 years)

• Ability to collaborate and lead strategy with internal stakeholders

• Excellent presentation skills

• An ability to travel

• Fluency in English is required

- Desirable

• 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

[Key Relationships to reach solutions]

- Internal (to AZ or team)

• R&D team

• Medical Affairs

• Regulatory affairs

• New Product Planning

• Market access

• Marketing

• Compliance Team

- External (to AZ)

• Service Providers

• Regulatory bodies

• Payor/reimbursement agency

• Other local and regional stakeholders

• Healthcare professionals

• Medical association

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