Senior Medical Director, Global Clinical Development at AstraZeneca in Gaithersburg, Maryland

Job Description:

"US AstraZeneca offices will be closed from December 25th to January 1st, re-opening January 2nd. We encourage you to apply to jobs of interest and we will review applications upon our return."


Are you ready to lead the future with an ambitious spirit? As a Senior Medical Director, Global Clinical Development, you will be at the helm of a matrix organization, directing a team of Clinical Scientists working on a late phase vaccine clinical development program. You will be accountable to the VP of Clinical Development, and your leadership will be instrumental in crafting an inclusive culture of growth and development within the V&I business area. Are you up for the challenge?



Accountabilities

• Providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of infectious diseases


• Help design, execute, and interpret clinical trials in one or more development programs (Phase 1 through Phase 3)


• Lead the Clinical Team as the Clinical Development Lead and work closely with other colleagues in other internal functions including Patient Safety, Biometrics, Regulatory Affairs, and Clinical Operations


• Build strong relationships with a network of external scientific specialists and opinion leaders.


• Medical oversight to ensure the safety of study participants including review of Adverse Events of Special Interest and Serious Adverse Events and review and writing of safety narrative reports.


• Medical oversight responsibilities for medical activities outsourced to third party vendors.


• Provide expert medical input and write clinical study documents such as protocols and study reports as well as regulatory documents and responses with regulatory authorities.


• Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.


• Prepare publications and presentations for scientific meetings and congresses.

Required Skills/Experience:

• Experienced physician (MD or MD/PhD) with clinical experience, preferably in pulmonology with expertise in infectious disease.


• 10 plus years of experience in clinical drug development, preferably from pharma industry for at least several years, with experience in developing clinical strategy/development plans, authoring of all clinical study document types, management of CROs running clinical trials, authoring of health authority submissions.


• Good understanding of clinical trials methodology


• Experience in the design, execution, and interpretation of clinical studies (e.g., medical monitoring, data cleaning)


• Proven experience in line management, performance management, capacity management, and budget management.


• Excellent verbal and written communication skills (including giving presentations) in English.

When we put unexpected teams in the same room, we spark 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 outstanding and daring world.


The annual base pay (or hourly rate of compensation) for this position ranges from $265,781 to $398,671. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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.


At AstraZeneca, we are a change-maker on the world stage at an exciting frontier of medicine. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises. We are committed to our central role in addressing pandemic and endemic diseases and ensuring our products continue to reach and benefit millions of people around the world. We are standout colleagues who invest in ground-breaking collaborations, local partnerships, and commercial initiatives. In everything we do, people come first. Every decision and action are centered around how we can serve them better. We are challenging the norm, going above and beyond to find solutions for the people receiving our medicines.


Join us in making a meaningful and lasting difference in the world. Be a part of the excitement and success of a global team with the brightest minds. Here you will find a dynamic community where diversity is our strength and reflects the variety of the populations we serve-where everyone is empowered to speak up and share ideas.


Ready to make your mark? Apply now to join our team!


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now