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Global Clinical Program Lead, Clinical Development
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At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in something small. We empower our people to seek these out, and we support them to pursue the opportunities they find. We are seeking a strategic **Global Clinical Program Lead** with deep understanding of the Oncology therapeutic area, with specific expertise in oncology, to join our **Late Oncology Clinical Development** team at **AstraZeneca**. As GCPL, you will be part of a cross-functional team responsible for clinical development strategy and execution of studies with the aim of developing new therapies to benefit patients with cancer. **Responsibilities include**: - Own 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, Good Clinical Practice and regulatory requirements - Design concept delivery within assigned program of studies - Ensure clinical and scientific content for the product or indication(s) is aligned to Global Product Team strategy - With the operations leads, ensure that the clinical program team rapidly implements new processes, systems and learnings - Promote and enable cross-functional, proactive and solutions-oriented team actions and behaviours - Provide strategic clinical and scientific knowledge 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 input into development decision points and target labelling with insights integrated from advisory boards. - Proactively drives questions and ideas that support 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 impactful information - Serves as a source of medical and scientific knowledge for the Product Team, in the analysis and interpretation of medical and scientific data **Essential for the role** - Life Science-based degree at Masters or above (i.e. M.D., PHD, PharmD, Masters in Life Science-based area) - 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 clinical delivery with demonstrated examples of 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 proficiency. - 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 optimally with internal and external collaborators - Demonstrated leadership qualities with focus on collaborative working skills, trust and willingness, irrespective of cultural setting - Agile responsiveness to scientific data. Credible in scientific and commercial environments **Desirable for the role** - MD or PhD in scientific discipline - Excellent general medical knowledge - 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 - Demonstrated ability to lead, coach, and mentor junior physicians/scientists. **In-office Requirement**:When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. - This role may be located in Gaithersburg MD, Waltham MA,
