Location options: Boston, MA, Gaithersburg, MD, Barcelona, Spain or Gothenburg, Sweden
Make a more meaningful impact to patients' lives around the globe
Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
The Role:
This is an excellent opportunity for a motivated drug developer to shape the Immunology pipeline and lead innovative clinical stage programs.
In this position, you will provide medical leadership opportunities for preclinical and clinical stage assets, across indications such as SLE, Systemic Sclerosis, Sjogrens and Rheumatoid arthritis, and spanning multiple modalities (small molecules, monoclonal antibodies, bi-specific and tri-specific antibodies, oligonucleotides). You will provide clinical development leadership for cross-functional teams to support early phase clinical development activities. These include the creation of overall clinical development plans and clinical study design, as well writing protocols, medical monitoring and ensuring timely execution of studies, all in close collaboration with relevant internal and external partners and clinical research organizations, and involvement in in-scope external innovation / business development activities.
The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly-effective internal and external team player as well as terrific communicator and collaborator.
What you will do:
Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product in compliance with GCP
Provide impactful medical strategy and clinical expertise to Research, Translational Medicine, Early and Late stage Clinical Development and Commercial Partners, including in the development of therapeutic area strategy
Closely follow medical developments within assigned areas and disseminate new information within Clinical Development and wider organization, to transform trends and emerging data into agile clinical plans
Work closely and collaborate across early and late R&I clinical development, partner functions and wider AZ organization to ensure design and delivery of clinical development plans with high quality and speed
Represent early R&I clinical development to external stakeholders, including investigators, key external experts, governmental/policy groups and community/patient advocacy groups
Medical Lead for regulatory communication and preparation of higher level documents
Ensures internal and external peer review of potential study/program design
Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
Provide clinical strategic input to in-licensing opportunities
Qualifications:
Advanced degree in a relevant scientific discipline (MD and/or PhD)
10+ years of experience in clinical development in relevant immunology indications, with background working in early clinical development (first in human through Ph2b)
Demonstrated track record in leading cross-functional teams and delivering results
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Understanding of the entire drug development process, including clinical and non-clinical study design and execution
Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative 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 the appropriate conduct of clinical studies in the United States, Europe and rest of world
Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
Excellent analytical, problem-solving and strategic planning skills
Ability to thrive in a fast-paced environment
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 at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not 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 $309,354-$464,031. 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 to participate in 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 coverage in accordance with the terms and conditions of the applicable plans. Additional details 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.
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Date Posted
26-Jul-2024Closing Date
22-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.