Global Medical Affairs Leader, Respiratory Inhaled
2 weeks ago
At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible.
AstraZeneca is a science-led, global biopharmaceutical company, with a focused portfolio in core therapies. We are committed to improving the health and lives of people across the globe, through our broad research and development platform, and a growing late-stage pipeline. Working in over 100 countries, we have strength in emerging markets, and our medicines are used by millions of patients and clinicians worldwide
**Mission & Objective **Description**:
BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies and supports our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. BPM aims to lead AZ in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do.
In order to accomplish our goals and enable the best patient outcomes, we look for AZ medical network leaders to have five (5) core capabilities and act as role models to our AZ values. These capabilities include:
Track record of building and maintaining a deep and continued connection to Medical Practice/healthcare delivery Collaborative/matrix management skills with a focus on leading diverse groups (e.g., cultural, geographical, functional) to achieve excellent results in shared goals Well-developed communication and influencing skills with the ability to distil complexity down to what matters to our stakeholders Strong financial/budget and project management skills Business acumen
Reporting directly to the Medical Head of the Product, the MAL, Triallist will design and deliver impactful, high quality Ph3b/Ph4 clinical studies and RWE to differentiate the brand, address market access challenges, drive innovation and advance clinical practice.
**Accountabilities/Responsibilities**:
Designs clinical trials within relevant respiratory product/portfolio to address important evidence gaps, including TPP development, clinical trial protocol oversight, and study physician responsibilities Works collaboratively with Medical Evidence, R&D colleagues, and Operations to deliver studies Supports the implementation of the BPM product strategy globally and regionally Closely follows medical developments within Therapeutic Area and disseminates new information to transform clinical trends and emerging data into new plans Liaises with the internal and external medical community to drive insight and innovation into clinical trials Supports team leader at Global Product Team, Global Brand Team and Global Medical Team Accountable for engaging and cultivating relationships with leading global KEEs to gain: contribution/ participation in advisory boards, greater understanding of the therapeutic area and insights into unmet patient needs Represents AZ at scientific and medical forums, including medical education forums, scientific roundtables, congresses, and symposia Ensuring the alignment of the publication and medical evidence plans to the Medical Strategy and Medical plan. Delegate for Medical Head and other MALs as required Manages other specific respiratory/medical projects as required
**Reporting Relationship**
- None
**Budget responsibility**
- Responsibility for study delivery on time and within target budget
- Ensures effective management of assigned budget for defined activities
**Minimum Requirements -** Education and Experience**
- Experience in leading a clinical program to support an indication or promotional claim or scientific exchange including overall design, clinical development plan and TPP
- Clinical scientist with specialist training in either Pulmonary Medicine or Allergy/Immunology or internal medicine with clinical development experience
- Minimum of 3 and ideally more than 5 years in Industry, with experience in leading clinical trials (including Phase 4), study design concepts and protocols
- Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing submission dossiers
- Previous experience of leading cross-functional study delivery teams
- General understanding of statistics, safety, regulatory requirements
- Demonstrated experience with developing Global or local medical strategies
- Strong network of external experts in Respiratory medicine
**Preferred Requirements**
- Medical Affairs knowledge
- MD
- Experienced clinical trial specialist
**Skills and Capabilities**
- Patient-centered but commercially aware, values-driven approach
- Level 4 leadership capabilities
- Proven ability to engage, influence and build effective relationships with KEEs
- Strong ve
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