Do you have expertise in Oncology clinical development and passion for developing late phase clinical program strategies?
Would you like to apply your expertise to impact the way cancer is treated, and make a meaningful difference to patients, in a company that follows the science and turns ideas into life changing medicines?
Then AstraZeneca might be for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next.
What you’ll do
As a Global Clinical Program Lead, supporting efforts in breast cancer, you are accountable to the Global Clinical Head for a significant proportion of the clinical program, usually an indication-aligned cluster of clinical studies. This role is normally applied to portions of the program that have the highest degree of complexity based upon the known science or the size of the program, and may also include a third-party collaboration.
In this capacity, you will lead a team of Global Development Medical Directors and/or Global Development Scientist Directors, and also work cross functionally to support the design, conduct, monitoring and data interpretation of multiple studies. You will ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally. As such, you will get the chance to be strategic and patient focused, generating opportunity and value for the asset or indication with an entrepreneurial mindset to maintain a competitive advantage.
The individual would lead the multi-functional Clinical Program Team; set team vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share learnings through your portfolio of studies. Additionally, the individual will be expected to be a catalyst of new ways of working, identifying and leading process improvement projects for clinical studies. The are expected to be a role model in the function, providing hands-on coaching and mentoring to staff, and be actively involved in the shaping of the department. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
- Acting as the single point accountable leader for the design, delivery and interpretation of clinical studies, ensuring the ethical and scientific integrity of the plans, studies and products in compliance with AZ policies and Good Clinical Practice
- Ensuring overall clinical and scientific content for the product or indication(s) aligned to Global Product Team strategy
- Setting team vision and goals aligned to therapeutic area leadership and product strategy
- With the operations leads, ensuring that the clinical program team rapidly implements new processes, systems and learnings
- Through end-to-end knowledge of drug development and situational leadership capabilities, promoting and enabling cross-functional, proactive and solutions-oriented team actions and behaviors
- Is accountable for Global Development Medical Directors and Global Development Scientist Directors and study design concept delivery within their assigned program of studies
- Through integrated understanding of the product strategy, provides strategic clinical and scientific knowledge and support to the Study Physicians and Scientists for initiation, execution and completion of the clinical studies within the assigned portion of the Program
- Accountable to represent the company and deliver clinical information / answers to Regulators, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves medical issues in the study team
- Under delegation by the Global Clinical Head, provides strategic clinical and scientific knowledge into development decision points and target labelling with insights integrated from advisory boards.
- Proactively drives scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities that generate value for the asset
- Maintains up-to-date knowledge of the relevant scientific literature, and can clearly communicate key impactful information
- Serves as a source of medical and scientific knowledge for the Product Team, in the analyses and interpretation of medical and scientific data
Essential for the role
- Graduate of a recognized school of medicine with an M.D. degree or equivalent (preferred), PhD (or other complementary degree) in scientific discipline, or PharmD
- Significant (>7 years) clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Proven track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs
- Ability to form and maintain an excellent reputation outside of AZ, can interact F2F and TC with regulatory agencies, with high credibility in scientific, clinical and drug development competency.
- Explores positions and alternatives to reach agreements and solutions. Presents clear arguments to gain acceptance of ideas and influences outcomes to meet organizational objectives
- Good knowledge of biostatistics, Clinical Development, global regulatory environment and pharmacovigilance and working knowledge of medical affairs and payer environment
- Proven cross-functional teamwork and collaboration skills
- Excellent presentation skills. Can communicate effectively with internal and external collaborators
- Demonstrated leadership qualities with focus on collaborative working skills, trust and openness, irrespective of cultural setting
- Agile responsiveness to scientific data. Credible in scientific and commercial environments
Desirable for the role
- Excellent general medical knowledge, specifically in the breast cancer field
- Experience with clinical trials operations
- Experience from different organizations
- An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence Drug development.
- An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements
- Line management experience
- Demonstrated ability to lead, coach, and mentor junior physicians/scientists.