Medical Director, Early R&I Clinical Development

Are you ready to shape and deliver the AstraZeneca Immunology pipeline?

If you are a motivated drug developer, this is an excellent time to join!

Who We Are 

In the Respiratory and ImmunologyTranslational Sciences andClinical Development(TSCD)team, we are investigating the drivers of key respiratory and immunology diseases, with access to pioneering science, innovative drug discoveryapproachesand key collaborations with academic centers around the world. We are investigating a wide range of drug modalities – small molecules, biologics,oligonucleotidesand cell therapies – across multiple diseases with high unmet medicalneed.

TSCD in R&I is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 – Phase 2), while collaborating closely with our late phase clinical development colleagues who guide later phase clinical studies. We are a diverse team of experienced physicians,clinical scientistsand translationalmedicinescientistswho collaborate with scientists and late clinical development to define our early phase clinical development strategies, design innovative clinical trials, develop andvalidatenew clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.

What You Will Do 

Asa Medical Director, you will provide medical and scientific input to preclinical and clinical stage assetswithin the context of an immunology clinical team.This will include the creation of overall clinical development plans and clinical study design aswell writingprotocols, key study and health authority documentation, medical monitoring and ensuringtimelydelivery of studies, all in close collaboration with internal and external partners and clinical research organizations.

Experience in Rheumatologyor Gastroenterology is strongly preferred. The successful candidate will thrive in a fast-paced, proactive can-do culture, bea strong communicator and collaborator.

• Responsible for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans,studiesand product in compliance with GCP.

• Provide guidance in the medical strategy and clinical/diseaseexpertiseto Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of across functional teams.

• Closely follow medical developments within the autoimmune / inflammatory diseases anddisseminatenew informationwithin Clinical Development and the widerorganizationto transform trends and emerging data into agile and innovative clinical plans.

• Work closely and collaborate across early and late R&I clinical development, partnerfunctionsand wider AZorganizationto ensure design and delivery of clinical development plans with high quality and speed.

• Represent Early R&ITSCDto external partners, including Investigators, key externalexpertsand patient advocacy groups.

• Medical Lead for regulatory communication and preparation ofhigher leveldocuments

• Ensures internal and external peer review of potential study/programdesign.

• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.

• Supportestablishingscientific collaborations with academic collaborators to support key advancing translational science activities

• As available, provide clinical strategic input to in-licensing opportunities.

Basic Qualifications:

• Advanced degree in Rheumatology/Clinical Immunology/ Gastroenterology(MD or PhD). 

• Minimum of5 years combined industry or relevant clinical or research experience.

• Understanding of the drug development process, including clinical and non-clinical study design and execution.

• Thoroughunderstanding of clinical researchmethodologyand biostatistics principles, tofacilitateinnovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.

• Thorough command of FDA, MHRA and ICH GCP guidelines to ensure theappropriate conductof global clinical studies in the United States,Europeand rest of world.

• Attention to detail, internal drive to generate high-quality work, andsenseof passion and urgency to achieve team and program goals.

• Demonstrated experience managing complex projects and working collaboratively with multiple stakeholdersregardingnew strategies to ensure consistent communication.

• Demonstratedtrack recordin delivering results.

• Outstanding verbal and written communication skills.

• Excellent analytical, problemsolvingand strategic planning skills.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work atpaceand challenge perceptions.That’swhy we work, on average, a minimum of three days per week from the office. But thatdoesn'tmeanwe’renot flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $249,827 - $374,740.However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.