Senior Medical Director

Job Description

Location

US: Boston or Gaithersburg, MD

Spain: Barcelona

Sweden: Gothenburg

Are you an experienced professional in drug development specializing in immunology, rheumatology, or inflammatory bowel disease? Do you want to join a skilled team of clinical research professionals, scientists, and physicians who are transforming scientific discoveries into early-phase clinical development plans across various diseases?

This position is available at one of our strategic Global Research and Development sites in the US, Spain, or Sweden.

At AstraZeneca, we are committed to creating a positive work environment with a diverse team that values collaboration and innovation. Our focus is on enhancing healthcare and quality of life for patients by developing groundbreaking therapies that address unmet medical needs and offer clinicians new evidence-based treatment options.

Who We Are

Within the Respiratory and Immunology Early Clinical Development team, we are exploring the underlying causes of major respiratory and immunology conditions, utilizing cutting-edge science, inventive drug discovery methods, and collaborations with academic institutions globally. We are researching various drug types - from small molecules to cell therapies - for multiple diseases with significant medical needs.

Early Clinical Development, a division of the Early R&I group, merges science with clinical drug development to deliver innovative early-phase clinical studies (Phase 1 – Phase 2b). We closely collaborate with our late-phase clinical development counterparts who oversee our phase 3 clinical trials. Our diverse team of experienced physicians and scientists works alongside researchers and translational medicine experts to shape early-phase clinical strategies, design pioneering phase 1-2b clinical trials, establish new clinical endpoints, and translate scientific concepts into proof-of-concept studies for specific patient groups.

We are seeking a Senior Medical Director (physician) and/or Senior Director (clinical scientist) to join us. In this role, you will have the opportunity to contribute to leading-edge early clinical and translational research in the field of immunology at AZ. You will be a key player in advancing a varied pipeline encompassing numerous ongoing clinical programs.

What You Will Do

You will oversee and participate in global early-phase I-IIb clinical trials and associated clinical research projects for compounds targeting immunology conditions such as SLE, RA, and IBD. You will also be a key expert in designing, conducting, monitoring, interpreting data, and reporting on these studies. Additionally, you will collaborate with cross-functional teams within our ECD group and across the broader early R&I organization to shape strategies and development plans for compounds focusing on various indications, including asthma, COPD, and other immunology conditions.

You will lead clinical development initiatives in cross-functional teams to support early-phase clinical development tasks. These responsibilities include formulating overall clinical development plans, creating clinical study designs, drafting protocols, essential study and regulatory documents, medical monitoring, ensuring timely study completion, and collaborating closely with internal and external partners and clinical research entities.

Responsibilities

• Oversee the design, execution, and interpretation of clinical studies from initial human trials through Ph2b, ensuring adherence to GCP standards and the scientific integrity of studies
• Conduct continuous monitoring of clinical data to ensure quality and safety, including SAE/SUSAR/protocol deviations, periodic review of emerging safety data by SRC/DMCs, and supervise investigational sites on protocol-related issues and anomalies in data trends
• Develop clinical development strategies from early target identification to Phase 2b (with senior guidance as needed) and ensure alignment across the broader AZ organization
• Offer clinical/disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development, and Commercial teams as part of cross-functional collaborations
• Stay current with medical advancements in autoimmune/inflammatory diseases, share new findings within Clinical Development and the broader organization to shape innovative clinical strategies effectively and promptly
• Represent Early R&I Clinical Development in internal governance interactions and engagements with external stakeholders, including Investigators, key external experts, and patient advocacy groups (e.g., regulatory bodies, sites, CROs, and KEEs)
• Act as the primary medical representative for regulatory communications and preparation of advanced study documents (protocols, briefing books, ICFs, PIPs, SAPs)
• Support the validation of pharmacodynamic/disease markers for early efficacy assessment
• Provide clinical strategic input for potential in-licensing opportunities, as available

Who You Are

We are looking for a medical doctor with specialized clinical training or a scientist with an advanced scientific degree (PhD or Pharm D) and relevant training for this role. You should possess a minimum of 7-10 years of clinical research experience, including substantial involvement in early-phase drug development for non-oncological conditions within the biopharmaceutical/biotechnology sector. You should thrive in a dynamic, proactive environment, excel as an internal and external team player, and demonstrate strong communication and collaboration skills.

Required Education Skills and Experience

• Advanced degree in a pertinent scientific field (MD, PhD, PharmD), with a focus on immunology/rheumatology considered a plus. Strong expertise in rheumatology, immunology, and/or inflammatory bowel disease through training and/or experience is highly desirable.
• Extensive experience (over 9 years) in early-phase clinical development, including hands-on involvement in designing, executing, and interpreting multiple Ph1/Ph2 studies in relevant non-oncology indications
• Significant background in drafting relevant regulatory documents, such as INDs, protocols, ICFs, PIPs, briefing books, as well as responding to regulatory queries and site issues
• Comprehensive understanding of the entire drug development process, encompassing both clinical and non-clinical study design and implementation, along with a robust grasp of clinical research methodology and biostatistics principles to enable innovative and efficient clinical trial design and data-driven clinical development plans with clear decision-making criteria
• Proficient knowledge of FDA, MHRA, and ICH GCP guidelines to ensure global clinical studies are conducted appropriately in the US, Europe, and other regions
• Detail-oriented approach, internal motivation to deliver high-quality work, and a sense of commitment and urgency to achieve team and program objectives
• Proven track record in managing complex projects and collaborating with multiple stakeholders to develop new strategies and maintain consistent communication
• Demonstrated history of delivering results
• Outstanding verbal and written communication abilities
• Strong analytical, problem-solving, and strategic planning skills
• Ability to thrive in a fast-paced setting

Why AstraZeneca?

We seek leaders at all levels - individuals with expertise who can build compelling arguments, engage diverse partners, and communicate effectively with various audiences. Early clinical development plays a crucial role in discovering new treatments for patients with significant unmet needs. With this responsibility comes the opportunity for personal growth fueled by your curiosity and dedication, alongside support from colleagues, mentors, and leaders, enabling you to enhance your skills, capabilities, and impact. We offer competitive compensation and exceptional benefits.

By bringing together diverse teams, we foster innovative thinking that can lead to life-changing medications. Working together in person provides a platform for connection, rapid progress, and challenging status quos. While we typically work in the office a minimum of three days a week, we also embrace flexibility, balancing office expectations with individual needs. Join us in our distinctive and ambitious work culture.

So, what's next?

Can you envision yourself joining our team? Fantastic - we look forward to hearing from you. Feel free to apply

This is what it's all about:

Date Posted

13-May-2024

Closing Date

11-Jun-2024Our aim is to establish an inclusive and fair environment. We want individuals to feel welcomed at AstraZeneca and Alexion right from our recruitment process. We encourage and review applications from all qualified candidates, irrespective of background. We provide reasonable accommodations to support all candidates in performing at their best. Should you require any adjustments or accommodations, please indicate this in the application form. AstraZeneca mandates that all US employees be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as permitted by law.

---