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Global Clinical Program Lead, Late Development Oncology, Lung

Location Cambridge, England, United Kingdom Cambridge, Madrid, Spain Milan, Lombardy, Italy Warsaw, Mazovia, Poland Job ID R-143906 Date posted 24/07/2022

Do you have expertise in Oncology clinical drug 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 the place for you!

About AstraZeneca

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. We are more than one of the world’s leading pharmaceutical companies.

Oncology Research & Development, Late Development Oncology

Our ambition is to eliminate cancer as a cause of death. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on ground-breaking science with the latest technology to achieve breakthroughs.   AZ is a place built on courage, curiosity and collaboration – we make bold decisions driven by patient outcomes. Late Development Oncology focusses on phase II - III clinical trials.


Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. 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. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges. This position will focus on Lung Oncology.

The Global Clinical Program Lead is 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. They will be required at times to deputise for the Global Clinical Head.

You will work with the study physicians to support the design, conduct, monitoring and data interpretation of the studies to 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. You’ll be expected to be strategic, generate opportunity and value for the asset or indication and be entrepreneurial to maintain a competitive advantage.

The individual could lead the Clinical Project Team (CPT) and set team vision and goals against Therapy Area Leadership Team (TALT) and product strategy, align team against timely decision making, facilitate balancing of cost/time/quality against clinical development objectives, ensure forward risk mitigation strategies, enable quick and effective trouble shooting, represent product at health authority interactions, act as Publication Sign-Off (PSO) Lead or delegate, rapidly implement new processes and systems and sharing/seeking learning through your portfolio of studies.

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.

Typical Accountabilities, what you will be doing:

Clinical Program Team Leader (if relevant)

• Accountable for the CPT deliverables.

• Overall clinical and scientific content for the product or indication(s) aligned to Global Product Team (GPT) strategy.

• Sets team vision and goals aligned to TALT and product strategy

• With the Director Clinical Director (DCD), ensure the CPT rapidly implements new processes, systems and learning.

• Prioritization of clinical activities within the clinical program and ensures forward looking risk mitigation strategies

• Through end-to-end knowledge of drug development and situational leadership capabilities, promotes and enables

cross-functional, proactive and solutions-orientated team actions and behaviours

• Enables quick and effective trouble shooting within the CPT and its associated sub-teams

• Coaches individual team members as needed, building future AZ talent through the matrix team model

• Acts as PSO sign off (lead or delegate)

• 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

Clinical expert accountabilities

• Is accountable for study designs 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 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 GCH, provides strategic clinical and scientific knowledge into development decision points Target Product Profile (TPP)/TPC and target labelling with insights integrated from Key External Expert (KEE) advisory boards. TPP/TPC development – need to understand the interplay between clinical development, lifecycle management, commercial objectives and regulatory requirements.

• Often works as a delegate of the Global Clinical Head (GCH) across several studies (e.g. a paediatric programme, or a set of mechanistic / differentiating studies)

• Can be the clinical representative on Global Product Teams and/or other sub-teams for the assigned part of the program

• Has the knowledge and ability to work across projects, and rapidly identify and implement development plans when moving into a new disease area

• Ability to form and maintain an excellent reputation outside of AZ, can interact face-to-face and virtually with regulatory agencies, with high credibility in scientific, clinical and drug development competency.

• Proactively drives scientific questions and ideas that support clinical hypothesis generation and life cycle management opportunities that generate value for the asset

• May be required to support business development representing clinical in the due diligence process for new acquisitions

• If the holder of the role is not medically qualified, they will show appropriate judgement capability to refer specific medical queries and tasks to the designated medically qualified representative of the team.

Trial conduct and hands-on delivery accountabilities for a portion of the Program

• Is accountable to the GCH or delegate for the clinical aspects and design and delivery of studies

• Collaborates seamlessly and efficiently with global colleagues at other R&D sites

• May be accountable to GCH (or delegate) and TA leadership for identifying risks and proposing mitigation strategies to also deliver successful Phase II, III or IV studies

• If required, provides study level clinical support and leadership (as Study Physician – required holder of an M.D. degree) for one or more studies

Scientific clinical analytical accountabilities

• Maintains up-to-date knowledge of the relevant scientific literature, and is able to clearly communicate key impactful information, as applicable

• Delivers analyses of clinical data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.

• Serves as a source of medical and scientific knowledge for the Product Team, in the analyses and interpretation of medical and scientific data.

Messaging and external impact accountabilities

• Maintains a high degree of understanding and awareness of new and emerging clinical developments, globally.

• Accountable for building trusting relationships with steering committees/executive committees and with AROs/CROs

• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues

• Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products

• Maintains strong networks globally with KEEs, prescribers, regulators and payers, through medical scientific report.

• If required, able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies

Education, Qualifications, Skills and Experience

Essential

Graduate of a recognized school of medicine with an M.D. degree or equivalent or a life science-based degree

• Significant Clinical research expertise in Oncology 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

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

Desirable:

PhD (or other complementary degree) in scientific field

• Good 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

• Line management experience

• Demonstrated ability to lead, coach, and mentor junior physicians/scientists.

• Demonstrated ability leading and motivating teams in a matrix environment.

Location: Cambridge UK, Madrid Spain, Milan Italy or Warsaw Poland

Salary: Competitive + Excellent Benefits

Closing Date: 22nd August 2022

Next steps, if the role looks suitable please apply!

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10001001 G CDPN R&D Oncology

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.