Therapeutic Area Lead Cardiovascular
The Cardiovascular Therapeutic Area Lead plays a pivotal role in channeling AstraZeneca's scientific capabilities to make a positive impact on changing patients' lives.
This role is crucial within the CVRM Medical Affairs Department, ensuring solid scientific medical planning and execution.
The Medical Lead oversees the day-to-day operations of the MSL Manager and Medical Advisors (MAs) team, engages in local strategic planning, and provides guidance for MSL Manager and MA engagement with key external experts, healthcare professionals, and clinical investigators.
This role does not have commercial objectives but may communicate strategic objectives to commercial stakeholders to ensure alignment.
Accountabilities
Medical Plan Execution Support
- Develop and execute the local Medical Affairs Plan in line with AstraZeneca's CV strategy and the Global Brand Strategic Plan.
- Provide medical input to develop innovative approaches for delivering value at the patient, HCP, and healthcare system levels.
- Participate in or nominate local MA representatives to Global Medical Teams (GMTs).
- Communicate local insights regarding clinical treatment patterns, patient journeys, and payer systems to regional/global medical teams.
- Coordinate the local external expert advocacy plan.
- Ensure the local publication plan aligns with the Global strategy.
- Align MSL plans with Brand Medical Strategy and implement Field Medical Affairs strategy locally.
EAP and Compassionate Use Monitoring
- Manage Compassionate Use programs according to local SOP EAP management, with a trained MA or MSL as backup.
Cross-functional Team Collaboration and Support
- Partner with market access to strengthen the scientific value of products for local stakeholders.
- Collaborate with cross-functional colleagues to create and drive medical product tactics that enhance patient well-being.
Team Management
- Lead and empower a CV medical team; foster innovation and successful implementation of medical activities.
- Develop and lead field-based MSL Manager and MA teams in support of the Medical Plan.
- Recruit, onboard, manage performance, and develop careers.
- Facilitate scientific and skill training for MSL Manager and Medical Advisor teams.
Support of Clinical Trials
- Support global study delivery by SMM and CRO at the local level.
- Provide oversight to MSL Manager and MA team supporting clinical operations and evidence generation teams.
- Work with MEMI team to generate evidence plans and implement local AZ sponsored studies.
- Support investigators' proposals for clinical activities and approval processes.
Support Capability Building in Healthcare Ecosystem
- Develop interactions with local key stakeholders in CVRM.
- Ensure MSLs and Medical Advisors provide accurate scientific data to HCPs.
- Recommend scientifically meaningful medical programs.
Compliant with all Legal and Internal Requirements
- Oversee compliance with local regulatory requirements and AstraZeneca policies.
- Ensure timely completion of policy, guidelines, and compliance training.
- Monitor compliance with Veeva Medical CRM documentation.
- Ensure understanding of AstraZeneca's Global MSL Guide, Code of Conduct, External Interactions Policy, and Publications Policy.
Engage in Scientific Exchange
- Engage with the medical/scientific community credibly, representing AstraZeneca's dedication to science.
Build Capability of Other Internal and External Stakeholders
- Act as an educational resource to internal stakeholders.
- Manage activities and account relationships according to company values, code of conduct, guidelines, and legislation.
Essential Skills/Experience
- Senior professional with a strong track record in pharmaceutical companies with high ethical standards for medical departments
- Solid scientific background coupled with strong commercial orientation and market awareness
- Experience in the development and execution of clinical studies; late-stage clinical development or phase IV study experience acceptable; additional experience with non-interventional studies desirable
- Advanced leadership and stakeholder management skills
- Experience in product launch preparation and execution
- Thorough knowledge of local regulatory requirements related to medical affairs activities
- Strong leadership capabilities
- Excellent interpersonal skills
- Project management experience
- Extensive experience in relationship and stakeholder management
- Balanced mix between strategy and execution, driven by a past record of customer-centered mindset
- Deep understanding of regulations, good clinical practice (GCP), pharmacovigilance
- Proficiency in written and spoken Italian and English is mandatory
- Be a valuable example of AZ values & behaviors
Desirable Skills/Experience
Business Acumen:
- Understands AstraZeneca's values, objectives, CVRM strategy, external business environment, and fundamentals of running a successful business including financial management
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