Senior Medical Affairs Leader (Trialist) - Respiratory
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. 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.
Global Medical 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. This global role provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. Medical Affairs 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:
Experience in leading a clinical program to support an indication or promotional claim or scientific exchange including overall design, clinical development plan and TPP. 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.
- Designs and manages the implementation of the Global Medical brand strategy globally and regionally
- Designs and delivers interventional clinical trials within Therapeutic Area of expertise, including clinical trial protocol oversight and study physician responsibilities
- 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
- Delivers medical advocacy plan that drives successful launch of new indications and innovative and differentiated new medicines within the TA
- Builds TPP based on medical knowledge, insights and internal/competitor clinical data
- Supports team leader at TA Global Product Team, Global Brand Team and Global Medical Team
- Accountable for engaging and cultivating relationships with leading global Key External Experts s 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
- Responsible for the co-ordination of Medical activities including: Science Advisory boards, Symposia, topical workshops
- Ensuring the alignment of the publication and medical evidence plans to the integrated medical affairs plan (iMAP) and business strategy plan for the product
- Responsible for leading the initial development and ensuring the accuracy of medical promotional materials and communications prior to submission to GMQA (Global Medical Quality Assurance) for the final approval.
- Budget Responsibility
- Budget creation, delivery and management for accountable assets that is aligned with Medical Affairs budget processes -Study delivery on time and within target budget
- MD with specialist training in either Pulmonary Medicine or Allergy/Immunology or internal medicine with respiratory clinical development experience
- Minimum of 5 and ideally more than 8 years in Industry, with experience in leading clinical trials to support approval (Phase 2-4) (i.e experienced clinical trial specialist strongly preferred).
- Experience in leading a clinical study program to support an indication, including overall design, clinical development plan and TPP
- 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
Skills and Capabilities:
- Experienced clinical trial specialist (essential) with Medical Affairs knowledge (strongly preferred)
- Patient-centred but commercially aware, values-driven approach
- Level 3/ 4 leadership capabilities
- Proven ability to engage, influence and build effective relationships with KEEs
- Strong verbal and written communication skills in English
- Strong project management skills and experience of managing priority brands
- Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles
- Presentation and influencing/negotiation skills
- High ethical standards required
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.