Senior Director, DMPK Project Leader

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.  Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses.

We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

** Description of Role*
* Senior Director, DMPK Project Leader ensures delivery of all DMPK related activities working collaboratively as part of a cross-functional program team. These include nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical and toxicokinetic analysis. This role supports understanding pharmacokinetic, toxicokinetic, and ADME principles to enable progression of drug candidates across the portfolio.  A qualified candidate will have previous experience in PK modeling ideally for CNS drug candidates and a basic understanding of vital ADME properties for CNS drug candidate progression.

Furthermore, a qualified candidate will have end-to-end experience in drug discovery and development including NDA submission; will be able to partner with both discovery and development teams to enable the identification of lead candidates with optimal DMPK properties for progression into nonclinical development and the progression of lead candidates into clinical development.  

** Key Responsibilities*
* + Lead the filing of NDAs for DMPK

+ Deliver high-quality DMPK input and data to projects within established timelines

+ Utilize knowledge of DMPK to support/influence compound profiling, project progression and project strategy

+ Proactively calculate PK and toxicokinetic parameters, estimate safety margins and report results and interpretations to project teams and internal governance bodies

+ Lead, coordinate, and engage with DMPK colleagues, clinical pharmacologists, and toxicologists in project related activities

+ Prepare clear presentations related to the above for internal governance bodies

** Qualifications*
* + Ph.D. in Pharmaceutical Sciences,Pharmacology or a related field

+ Minimum of 10 years of industry experience in a biotech or pharmaceutical setting

+ Expert in DMPK sciences with knowledge of drug discovery and development processes

+ Strong analytical and problem-solving skills

+ Experience in DMPK project leadership

+ Previous work in the discovery and/or development of CNS drug candidates

+

Experience with regulatory submissions including NDAs for small molecules

+ Knowledge, experience, and proficiency in supporting GLP-compliant studies

+ Good knowledge of all DMPK assays including the use of  _in_   _silico_  tools for PK prediction

+ Proficiency with Phoenix Win Nonlinand other software for NCA and PK modeling in small molecule drug discovery and development

+ Demonstrated ability to work cross-functionally and communicate scientific findings clearly and effectively

+ Collaborative mindset and operates with a sense of urgency

+ Strong, proactive communication skills

** Work Location*
* The Senior Director, DMPK Project Lead role based in the US, with occasional travel.

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