Director - ADME Project Leadership

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 177,000 - 308,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis seeks an experienced pharmaceutical scientist to lead ADME science across small molecules, biologics, peptides, ADCs, siRNAs, gene therapies and other modalities. You will serve as a technical leader within ADME and collaborate with Discovery, Toxicology, Chemistry, Clinical PK/PD and Regulatory to optimize properties and guide compound selection.

Responsibilities include delivering integrated data packages for regulatory submissions, designing experiments, interpreting

Qualifications

• Ph.D. required with 6+ years in drug metabolism and disposition.
• Experience in drug discovery across therapeutic areas.
• Experience with in vitro, in vivo and in silico ADME approaches.

Responsibilities

• Accountable for delivery of scientifically integrated data packages to guide compound selection and regulatory submissions.
• Partner with Discovery and Development to assess drugability and optimize ADME properties.
• Lead R&D initiatives to grow ADME capabilities across modalities (small molecules, biologics, peptides, ADCs, siRNAs, gene therapies).
• Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure–activity and structure–property relationships.
• Prepare data packages and develop content in regulatory documents to support global submissions and regulatory correspondence.
• Guide junior and senior scientists in best practices of multi-property optimization using mechanistic ADME principles.
• Communicate the value of mechanistic ADME approaches internally and with regulators.
• Build external networks and stay up to date with Literature.

Skills

Cross-functional collab

Communication skills

Analytical thinking

Problem solving

Education

Ph.D. in Pharmacokinetics/Pharmacology/Pharmaceutics/Biochemistry

Tools

SimCYP

GastroPlus

NONMEM

Matlab

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.

Lilly’s Drug Disposition team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of small molecules, biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities. You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts.

Responsibilities

• Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions.
• Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical PK/PD, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize ADME properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages.
• Lead R&D initiatives to grow and develop ADME/DMPK capabilities across experimental and drug modalities including small molecules, biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities.
• Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies.
• Prepare data packages and develop content in regulatory documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent ADME in face-to-face discussions with regulators.
• Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic ADME principles.
• Communicate the value of mechanistic ADME approaches both internally within R&D and externally including regulatory agencies.
• Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area.

Basic Qualifications

Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology.

Additional Skills / Preferences

• Experience in drug discovery and development across a variety of therapeutic areas.
• Deep experience with small molecules preferred.
• Additional experience with at least one other modality desired, such as biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities.
• Detailed understanding of pharmacokinetics, ADME, drug interactions and proficiency to communicate theory and concepts clearly.
• Ability to balance multiple projects and handle competing responsibilities.
• Experience with modeling software (e.g. SimCYP, GastroPlus, NONMEM, Matlab, etc.).
• Demonstrate strong communication skills with the ability to integrate diverse perspectives, deliver critical messaging, and influence leaders/key partners.
• Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.

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 - $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
• 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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