Senior Director, DMPK Project Leader (remote)

Eli Lilly and Company

United States

À distance

USD 192 000 - 308 000

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Il y a 5 jours
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Avantages offerts par ce poste

401(k)
Pension
Vacation benefits
Medical, dental, vision
Flexible benefits
Life insurance
Time off
Well-being programs

Résumé du poste

Lilly is seeking a Senior Director, DMPK Project Lead to ensure delivery of all DMPK activities within a cross-functional program team, including nonclinical PK, in vitro ADME, biotransformation, bioanalytical and toxicokinetic analysis.

The role supports understanding pharmacokinetic, toxicokinetic, and ADME principles to enable progression of drug candidates across the portfolio, with CNS drug experience and NDA submissions, partnering with discovery and development teams to enable lead

Qualifications

  • PhD in Pharmaceutical Sciences, Pharmacology or a related field.
  • 10+ years of industry experience in biotech or pharmaceutical settings.
  • Expert in DMPK with knowledge of drug discovery and development processes.

Responsabilités

  • Lead the filing of NDAs for DMPK.
  • Deliver high-quality DMPK input to projects within established timelines.
  • Influence project strategy using DMPK data and analyses.
  • Proactively calculate PK and toxicokinetic parameters and report results.
  • Collaborate with discovery and development teams across programs.

Connaissances

DMPK
PK modeling
CNS drugs
Regulatory submissions
Cross-functional
Communication
Leadership

Formation

PhD in pharm sci

Outils

Phoenix WinNonlin
NCA tools

Description du poste

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 owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work ® in 2026.

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
  • L ead, coordinat e, and engag e 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 ND As 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 WinNonlin and 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 .

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $192,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

  • including eligibility to participate in a company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance and death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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