Job Title: Director, Clinical Pharmacologist - Cell Therapy
Location: Gaithersburg, MD
Introduction to role:
Are you ready to make a significant impact in the field of cell therapy? As a Director, Clinical Pharmacologist, you'll play a pivotal role in advancing AstraZeneca's pipeline by implementing pioneering Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches. This dynamic and innovative position involves collaborating with various teams, including the Cell Therapy Clinical Pharmacology team, clinical development, regulatory, and more, to ensure consistent contributions across therapeutic areas. You'll be responsible for overseeing pharmacometrics modeling techniques and influencing partners to deliver effective solutions. This role offers the potential for future line management responsibilities and the opportunity to lead scientific and critical initiatives.
Accountabilities:
- Provide flexible, competent, and responsive service with quality and speed according to business needs; enhance productivity and cost efficiency.
- Develop a culture encouraging of MIDD approaches within the team, influencing key partners, collaborators, and regulators.
- Foster positive collaboration with partner functions such as Cell Therapy clinical development, Biostatistics, DMPK and Biosciences, Translational medicine, Pharmaceutical Sciences, and Regulatory affairs.
- Offer scientific and strategic input into Therapeutic Area Clinical Pharmacology plans and regulatory responses.
- Act as project clinical pharmacologist when required.
- Support evaluation of candidates for in/out-licensing.
- Contribute to staff learning and development through training and knowledge sharing.
- Monitor external/internal environments for new methodologies and promote innovation.
- Increase AstraZeneca's cell therapy visibility externally through speaking engagements and publications.
- Ensure CPQP contributions align with regulations and stay in sync with GCP and GxP principles.
- Prepare to lead a team delivering quality clinical pharmacology input from first-in-human studies to life-cycle management.
Essential Skills/Experience:
- Masters' degree required; PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience.
- Minimum of 6 years international drug development experience (early and late) or equivalent life science experience; prior cell therapy experience required.
- Ability to work independently, drive performance, and hold self and others accountable.
- Proven record of building successful internal/external partnerships and collaborations with cultural sensitivity.
- Strong leadership capabilities, including influencing skills.
- Experience in mentoring and developing others.
- Conceptual, analytical, and critical thinking skills.
- International scientific reputation gained from scientific publishing in quantitative clinical pharmacology.
- Ability to identify, develop, and carry out strategic clinical pharmacology activities.
- Relevant regulatory experience (written/oral) with a track record of regulatory filings.
- Knowledge of regulatory compliance processes specific to clinical pharmacology.
- Proficiency in written and spoken English.
When we put unexpected teams in the same room, we fuel 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 daring world.
AstraZeneca is where curiosity meets courage! Our commitment to science drives us to explore new frontiers in treating complex diseases. By fusing data and technology with scientific innovation, we aim to achieve breakthroughs that positively impact billions of lives globally. Our inclusive environment fosters collaboration across academia, biotechs, and industry, creating opportunities for lifelong learning and career growth. Here, we celebrate successes and failures alike as we push the boundaries of science to deliver life-changing medicines!
Ready to make a difference? Apply now to join our team at AstraZeneca!
The annual base pay (or hourly rate of compensation) for this position ranges from $158,500.80 - 237,751.20 USD Annual. 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.
