Senior Director/Executive Director – Neuroscience Physician
Senior Director/Executive Director – Neuroscience Physician
Competitive Salary and Benefits
AstraZeneca is a global, creative, biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have an exceptional workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energised and rewarded for their ideas and creativity.
With a rich heritage and a research and development focus on specific aspects of neurodegenerative diseases, analgesia and psychiatry, AstraZeneca continues to push the boundaries of science in neuroscience in collaboration with other innovative partners across industry and academia. A significant unmet medical need remains in the areas of cognitive disorders, chronic pain and other central nervous system disorders.
Reporting to the Head of Clinical Development of Neurosciences, and carrying accountability for delivery of the Neuroscience portfolio of large and small molecules through late discovery and early clinical development using internal and external resources. You will be an experienced physician and provide medical leadership to projects transitioning from discovery through the early stages of clinical development (Phase 1 to completion of Phase 2). Accountable as a project physician for the conduct of clinical studies in line with defined operating procedures, including study design, development of the clinical protocol and operational aspects.
What you will do
As a member of the Neuroscience unit you will be directly accountable for the conduct of one or more projects in the neuroscience portfolio.
Role responsibilities include:
Creation of the scientific strategy, development plan and approach to the project, to ensure efficient execution and delivery from candidate to end of Phase 2.
Represent the clinical and medical aspects of neuroscience assets at key milestones to governance committees e.g. Candidate Drug Nomination, First Time in Human study review, Phase 2 investment decision. Work with colleagues in the late stage development organization and with co-development partners to facilitate transition of products into pivotal trials.
Establish and approve scientific methods for the design and implementation of clinical protocols, data collection systems, data analysis including the statistical analysis plan and provide clinical input into the development and review of the clinical study reports. Lead the development and review of the clinical content for key documents e.g. IB, clinical study protocol, CTA and IND submissions
Play an active role in planning, conducting and evaluating clinical trials and supervising cross functional team members to ensure successful trial delivery
Serve as sponsor medical monitor for clinical trials with significant responsibility for safety surveillance. Undertake ongoing Benefit-Risk evaluation in partnership with Patient Safety and Pharmacovigilance colleagues.
Review and interpret study results as appropriate. Analyze and synthesize clinical data for publication, and international regulatory filings. Author clinical publications or provide input into communication and publication development.
Establish links between company experts in relevant departments, including regulatory, bio-pharmaceutical development, discovery, translational and pharmacology/toxicology sciences, to design, initiate and expedite clinical studies.
Engage in planning and management of advisory boards and other scientific committees.
Support assets transitioning from the pre-clinical portfolio into clinical development, with a key role in defining the early clinical development.
Selection and management of collaborators and vendors including academic groups, CROs, and technical expertise or services within AZ.
Supply to development of disease area strategies that integrate discovery research with clinical approaches to proof-of-concept in appropriate patient segments.
Provide scientific, clinical and medical expertise to other co-workers and project teams as appropriate.
Evaluate and recommend licensing and acquisition opportunities, in balance with internal R&D Biopharmaceuticals efforts, and in partnership with neuroscience LT members. Actively participate in due diligence activities required for bringing new assets into the portfolio.
Promote AstraZeneca R&D Biopharmaceuticals and AZ Neuroscience externally in the scientific and business and investment communities.
Actively participate in co-partnering discussions with external business partners. Provide scientific and clinical expertise to joint steering committees and/or clinical co-development teams in collaboration with external business partners.
Significant prior experience and a successful track-record of providing medical leadership to the commercial development of pharmaceuticals or biotechnology products is crucial.
Experience of clinical development for product(s) targeted to neuroscience indications would be an advantage. An understanding of the principles of translational science in the context of early clinical development, ultimately aiming to target medicines to specific patient populations with the optimal benefit: risk, is essential. Experience with the clinical development of biologic agents (mAbs, fusion proteins) or other newer modalities (e.g. ASOs, gene therapeutics) would be advantageous.
Must be an excellent communicator and collaborative worker, with leadership skills, and the ability to interact in a cross-functional environment with both internal and external business partners.
Job Complexity: High, must integrate and analyze non-clinical and clinical data as well as data/input from multiple internal and external functional areas. Synthesis of previous clinical data and ongoing medical safety data is required on daily basis. Must manage multiple tasks/programs with competing deadlines/priorities.
Supervision: Role is that of individual contributor. Must be able to operate independently in medical, safety and clinical development tasks with minimal supervision. Once direction is provided, must identify the challenges, generate solutions (or options) and either execute the plan or seek advice depending on strategic impact to company.
Qualifications required: MD, MBBS, MBChB or equivalent.
We are seeking an experienced pharmaceutical physician with specialist accreditation in a relevant discipline and a research background, or interest, in the neurosciences. Credentials in psychiatry and experience, or interest, in the development of therapeutics to address substance use disorder may be an advantage, but is not essential
So, what’s next?
Complete your application before the below closing date.
This role is open from 17th September 21 and welcome with your application no later than 16th October 21
Where can I find out more?
Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
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.