Clinical Program Director Jobs in Silver Spring, MD

Summary of Group:

TheHematologyResearch and Early Development (R&D) team has the accountability for all drug development activities inhematologyresearch from first in man studies, all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials). The team strives to deliver compelling preclinical,clinicaland translational data packages providing confidence in the dosing strategy, tolerabilityprofileand therapeutic efficacy of our candidate drugs to support investment inlate-stageclinical development, leading to drug approval.

Summary of Role:

We are looking for a highly qualified Global Clinical Program Lead (GCPL) candidate to lead the clinical development and execution of the product strategy for multiple projects. This individual will be accountable for the strategic clinical development plan and clinical execution of the compounds and reports to the Global Clinical Head (GCH) of the diseaseindication.In this role the candidate will work with other project leaders, scientific and clinical leaders as well as external experts to coordinated integrated project plans which can be delivered across functional boundaries. The candidate will ensure that diverse views within the team are heard and that a strongly empowered and motivated team iscreated andwilldemonstratehighly visible leadership within the oncology community, both within AZ and externally.

Responsibilities and Accountabilities:

• Leads clinical development teams responsible for novelhematology/oncology therapies from preclinical candidateselectionthrough proof of concept leading to Phase 3 investment decisions. The candidate will lead all regulatory submissions. Accountable for the clinical strategy and clinical execution of a portfolio of pre-clinical and clinical stage therapies.

• Accountable for the delivery of project according to quality, time,budgetsand resources

• Build strategic and coordinatedclinicaldevelopment plans which are aligned with businessobjectivesand are differentiated from competitor products.

• Accountable for the execution of the integrated product plan to agreed scope, timelines, and budgets

• Leads and communicates theclinicaldevelopment strategy at governance meetings, accountable for aligning with internal management and for communicating with external collaborators.

• Leadclinical aspects ofprojects from preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC):

• Responsible for allclinicalaspects of project strategy including translational, clinical development, patientselection, regulatory,pediatric, and Asian development strategy

• Development of the Target Product Profile, ensuring alignment with disease area strategy andlate-stagedevelopment

• Co-leads theClinicalProgramTeam(CPT) to effectivelyrun/mitigate/communicaterisk, make decisions, and handle conflict and change.

• Responsible formaintaininga high degree ofCPT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members.

• Ensure that there are robust processes, plans and data to enable Governance Bodies to make investment decisions and prioritize projects across the portfolio.

• Primary clinical focus will be CLL and related lymphoid malignancies in both early and late-stage studiesbut may not entirely be limited to this area.

Required Education and Experience:

• M.D. isrequired

• A minimum of 7 years of relevant experience

• Industry experience in drug development including experience in early and late phase drug development and regulatory knowledge.

• The successful candidate will havehematology/oncology clinical drug development experience,demonstratedleadership, and be able to critically navigate the science that underlies these programs. The candidate should be able to effectively communicate across a broad range of audiences and have an ability to clearly articulate project specific strategies as well as the overall oncology strategy.

• Strong knowledge and understanding of theHematologyOncology therapeutic area with experience in diverse biological mechanisms.

• Broad understanding of the evolving clinical landscape inhematology/oncology

• Lead the overall development of project strategy and be accountable for project plans, timelines, progress, and outcomes.

• Proven experience mentoring and motivating teams in a highly matrixed environment.

• Proven record of encouraging and leading internal and external cross-functional collaborations

• Demonstrated organizational and project management skills

• Proven success in influencing colleagues and senior leaders in various departments.

• Mustdemonstratehigh integrity.

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 ambitious world.

The annual base pay for this position ranges from $288,059 to $432,089 .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.

AstraZeneca is where science meets innovation to create impactful solutions! We challenge the status quo by leveraging data to drive scientific breakthroughs that make a tangible difference in patients' lives. Our collaborative environment fosters learning and growth, empowering you to contribute to meaningful research across global Therapy Areas. With countless opportunities for development, AstraZeneca is committed to investing in technology and expanding knowledge to maximize impact.

Ready to make a difference? Apply now to join our team and be part of something extraordinary!

Date Posted

Closing Date

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.