Senior Director, DMPK Project Leader

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 177,000 - 339,000; Full time

Benefits offered by this job

Company bonus program

Comprehensive benefits package

Job summary

Lilly in Indianapolis, IN is seeking a Senior Director, DMPK Project Lead to drive end-to-end DMPK activities across discovery and development teams. The role focuses on PK/PK modeling, ADME, regulatory submissions, and cross-functional leadership to advance CNS drug candidates.

The position requires 10+ years in biotech/pharma, a Ph.D., and proven DMPK leadership with NDA experience. Occasional travel and a strong sense of urgency are expected.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmacology or related field.
• Minimum of 10 years of industry experience in biotech/pharma.
• Expert in DMPK sciences with knowledge of discovery and development.
• Strong analytical and problem-solving skills.
• Experience in DMPK project leadership and CNS drug candidates.
• Experience with regulatory submissions including NDAs for small molecules.
• Proficient in GLP-compliant studies and PK modeling software.

Responsibilities

• Lead the filing of NDAs for DMPK.
• Deliver high-quality DMPK input to projects within timelines.
• Support compound profiling and project strategy using DMPK knowledge.
• Calculate PK and toxicokinetic parameters and report to governance bodies.
• Coordinate with DMPK, clinical pharmacologists and toxicologists on activities.
• Prepare presentations for internal governance bodies.

Skills

DMPK leadership

NDA submissions

PK/PK modeling

ADME knowledge

CNS drug development

cross-functional leadership

GLP studies

Phoenix WinNonlin

data interpretation

communication

Education

Ph.D. in Pharmaceutical Sciences or related field

Tools

WinNonlin

in silico PK tools

Job description

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 haveprevious 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 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 dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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

$177,000 - $338,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and 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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