Global Development Medical Director, Late Respiratory and Immunology Clinical Development

Regulatory Jobs; Boston (MA); On-site; USD 242,000 - 362,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Paid leaves

Health benefits

Job summary

AstraZeneca is seeking a Global Development Medical Director to provide medical leadership for late-stage respiratory and immunology programs. You will support global project teams, shape design objectives, and contribute medical input for regulatory documents while collaborating across international teams.

The role emphasizes leadership in late-stage trials, scientific analysis, and interaction with health authorities, with a flexible in-office work rhythm and a strong focus on collaboration

Qualifications

• MD/PhD with clinical pharmacology experience preferred.
• Experience in respiratory/immunology is desirable.
• Strong collaboration and cross-cultural communication skills.

Responsibilities

• Provide medical and scientific leadership for global development of new medicines.
• Lead design, execution and interpretation of pivotal trials (Ph2b and later).
• Develop relationships with external scientific experts and regulators.
• Collaborate with Patient Safety, Regulatory Affairs, and Clinical Operations.

Skills

MD or MD/PhD

3+ years pharma industry

3+ years clinical research

English fluency

Education

MD or MD/PhD

Job description

As aGlobal Development Medical Director,you will support the clinical project team andassisttheGlobal Clinical Project Leader andGlobal ClinicalHead with the design & interpretation process,establishingclear designobjectivesfor clinical programs and studies. You will provide medical input into the content of core labelling texts and medical support for commercial activities, support for medical monitoring of clinical studies.And, you will also provide medical and scientificexpertiseas well as tactical and strategic medical input to the development of AstraZeneca’s compounds; primarily from Phase IIbto Phase IV.This includes the design,deliveryand interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late-stage development.

In theBioPharmaceuticalsResearch & Development, Late-stage Development, Respiratory&amp Immunology function you will work in a truly international working environment, with opportunities to meet and discuss with keyexternal experts, other medical colleagues and experts in basic science, as well as commercial and regulatory functions.

Our therapy areaalignedgroups of physicians and scientistsprovideclinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.

TheGlobal Development Medical Directorwill work in a wide range of aspects in pharmaceutical medicine, and due to the globalresponsibilities,there will be a multitude of contacts with health authorities,colleaguesand marketing companies within AstraZeneca. This is an opportunity to take on the challenges of clinical development in a group of positive,focusedand highly motivated colleagues.

What you will do:

• Be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field ofrespiratory diseasesand wider range of immunologicaldisorders
• Have an importantroleproviding medical and scientific leadership in the innovative design,executionand interpretation of clinical trials in one or more developmentprograms.
• Build strong relationships with a network of external scientific experts.
• Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations.
• Be involved primarily in late stage (Ph2b and later) clinicalprogramswhile also collaborating with clinical colleagues supportingEarly(R&I)stage programs and medical affairs.
• Lead and contribute to medical monitoring of trials
• Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
• Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
• Develop and review protocols, informed consent, investigator’sbrochureand other clinical development documents.
• Participatein the preparation ofscientificpublications and presentations at scientific meetings and congresses.

Basic Qualifications

• MD or MD/PhD
• 3+ years of pharmaceutical industryexperience,3+ years of clinical research experience in the academic or clinical practice setting
• Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
• Fluent in oral and written English, with good presentation skills and effective communication

Desired Qualifications:

• Pulmonary medicine, Immunology, Rheumatology, Allergy, orDermatologybackgroundis desirable.

The annual base pay for this position ranges from $241,613 - $362,420 USD. 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 pay (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.

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 bold world.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.