Product Development Director jobs in Germantown, MD

Do you have expertise in, and passion for science? Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm?  We’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences. Locations: Gaithersburg, MD; Waltham, MA; Gothenburg (Sweden); Cambridge (UK)

What we do

We are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. The iBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

Why we love it

The future is bright at AstraZeneca as we bring ground-breaking therapies to complex disease to patients with critical needs.  Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare!

What you'll do

As part of the Integrated Bioanalysis (iBA) Global Team, you will report to the global head of iBA. You'll have responsibilities for leading a team of scientists designing and driving execution of complex bioanalytical strategies while making a direct and tangible impact on all aspect of AstraZeneca’s Biopharmaceutical portfolio, including therapeutic areas such as Cardiovascular and renal metabolism (CVRM), Vaccines and immunology (V&I),  Neuroscience (NSc.)as well as Respiratory and Immunology (R&I).

• You will also be responsible for driving the scientific strategic interface with our CRO partner.   

• You will drive interactions with key stakeholders across the business including but not limited to Safety Science, Clinical Pharmacology, Business Process Operations, Therapeutic areas, Patient Safety, Quality Assurance and Regulatory Affairs.  

• The ideal leader will design and implement ways of operating to ensure effective collaboration and delivery of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline.

• Working with a dynamic team you will be responsible providing solution to complex challenges while also building a dynamic team of scientist with diverse technical expertise and an innovative mindset.

• You will have the opportunity to have an immediate and lasting impact to our diverse pipeline.

• This is a role that requires a high level of collaboration across other strategy leads within Bioanalysis to ensure effective relationship with CROs. 

Education/Experience required:

• PhD in Biochemistry, immunology, molecular biology, bioengineering or related studies.

• 10 years of relevant experience with at least 2 years' experience driving teams to to bring drugs to market

Essential for the role:

• Ability to build effective partnerships across all therapeutic areas and key stakeholders within and outside AZ

• Ability to manage change in a fast past environment where bringing effective therapies to patients is our number one priority

• Establish and drive strategies on how iBA will ensure delivery of scientific and operational excellence across all modalities

• Proven track record driving scientific innovation

• Proven ability to develop   assets through all stages of drug development

• Proven experience as a Subject Matter Expert in pre-clinical and clinical bioanalysis capable of designing and driving bioanalytical strategies for PK/CK, PD biomarkers and immunogenicity assessments (humoral and cellular)

• Experienced leader with a proven track record of working with dynamic teams and driving talent development

• Experienced development bioanalysis leader capable of working across diverse fast-moving team, leading and implementing robust bioanalytical strategy to advance the portfolio

• Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk

• Experience across a range of bioanalytical applications and technical formats including but not limited to, Flow Cytometry,  Mass Spectrometry, ELISpot, viral assays, molecular assays (ddPCR, qPCR, RT-qPCR, NGS) cytokine assays, ligand binding assays etc.

• Lead a team that act as subject matter experts working with colleagues supporting assay transfer, scientific quality and study conduct at CRO partners

• Well-developed understanding of trends in the industry and deep knowledge of global regulatory expectations and guidance

• Collaborate with colleagues to ensure data and scientific insight are available for regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs

• Ability to interpret and integrated complex datasets to draw conclusions that drive key portfolio decisions

• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment

• Ability to develop, coach and mentor

• Background in pharmaceutical development

• Proven publication and presentation record

• Exceptional verbal and written communication skills

Desirable for the role:

• Matrix or line management experience

• Experienced in discovery bioanalysis for other drug modalities

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

If you’re curious to know more then please reach out to (contact person) We welcome with your application, no later than November 13, 2023.

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.