Global Clinical Program Lead (Lung), Late Oncology

1 day left

Gaithersburg, Maryland, USA / Cambridge, Cambridgeshire, England
08 Feb 2021
08 Mar 2021
AstraZeneca UK
Clinical Research
Full Time
Contract Type
Experience Level

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 Oncology to join our Late Development Oncology team at AstraZeneca. As Global Clinical Program Lead (GCPL), you will be part of a cross-functional team responsible for clinical development strategy, design and execution of studies with the aim of developing new therapies to benefit patients with cancer.

Main Duties and Responsibilities

In this role, you will be 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 a high degree of complexity based upon the known science or the size of the program, and/or due to a third-party collaboration that requires an incumbent to exercise greater expertise and judgement as well as to be effective in influencing and working across multifaceted partnerships. You will be required at times to deputise for the Global Clinical Head.

As a Clinical expert you will be accountable for study designs and study design concept delivery within your assigned program of studies. The GCPL will ensure internal and external peer review of potential study and program designs, and as such, you will present concepts and findings to the Global Product Team (GPT), working closely with cross-functional team leaders to develop new investments and to deliver trial data to appropriate decision points. You will have an integrated understanding of the product strategy, and will provide strategic clinical and scientific knowledge and support to the Study Physicians for initiation, execution, completion and data interpretation of the clinical studies, such that it allows determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally. You will align the study teams against timely decision making, facilitate balancing of cost/time/quality against clinical development objectives, ensure forward risk mitigation strategies and enable quick and effective trouble shooting.

You will be accountable to the GCH or delegate for the clinical delivery of studies and you will collaborate seamlessly and efficiently with Clinical Operations colleagues. If required, you may provide study level clinical support and leadership for one or more studies.

You will be accountable to represent the company and deliver clinical information and answers to external stakeholders, with high credibility in scientific, clinical and drug development competency.

Depending on the program and delegation, the GCPL could lead the Clinical Program Team (CPT) and set team vision and goals against Therapy Area Leadership Team (TALT) and product strategy, provide scientific and medical input to commercial activities including scientific components of business cases and value strategies, act as PSO lead or delegate and provide strategic input to in-licensing opportunities.

You will be expected to be strategic, generate opportunity and value for the asset or indication and be entrepreneurial to maintain a competitive advantage. You 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.

As a clinical team leader, you will partner closely with study physicians and medical scientists in the delivery of your components of the program, while allocating time to the coaching and development of less experienced clinical staff.

Essential Requirements

  • Bachelor's degree in a scientific discipline

  • Significant 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

  • 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.

  • Ability to lead, coach, and mentor junior physicians/medical scientists and a demonstrated ability of leading and motivating teams in a matrix environment are highly desirable

  • Excellent presentation skills. Can communicate effectively with internal and external collaborators

  • Agile responsiveness to scientific data. Credible in scientific and commercial environments

Preferred Qualifications:

  • MD degree or country equivalent (PhD in a scientific discipline preferred)

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well-qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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