Associate Director, Quantitative Pharmacology, Clinical Pharmacology

Location: Indianapolis

Job Summary The role of this position is to provide clinical pharmacology input into all phases of both small and large molecule drug development across multiple therapeutic areas, such as CNS, Nephology, Infectious Disease, Immunology and so on. The responsibilities will include, but not limited to,
1) Supporting all clinical pharmacology activities related to pre-IND, IND, Phase1-3, PK, PK/PD and regulatory submissions.
2) Supporting study design, execution, and reporting of clinical studies.
3) Working closely with multi-functional project team, interacting with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies.
4) Authoring the clinical pharmacology section in submission documents and representing the department at different product development team meetings.
5) Participating in the planning of pharmacometrics strategies and providing input on modeling and simulation activities.
6) Interacting with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.

Job Description Supports clinical pharmacology activities related to clinical study design, protocol development, study execution, reporting and interpretation of data Serves as clinical pharmacology lead on cross-functional project teams and support model-based drug development strategies for ongoing projects.

Conducts translational or clinical PK and PK/PD data plotting and analysis, such as noncompartmental analysis (NCA), correlation analysis, exposure-response analysis, meta-analysis.

Works closely with pharmacometrics team and provides input related to analysis and reporting of PK, PK/PD and exposure-response.

Authors clinical pharmacology sections in regulatory documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans; authors scientific manuscript or other publications

Works with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development. Works with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations (IVIVC), in vivo PK study and biowaivers for pre- and post-approval formulations.

Manages clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.

Qualifications/ Required Knowledge/

Experience and Skills:

Knowledge and

Competencies:

In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.

Hands-on experiences in PK and PK/PD analysis using software, such as Phoenix NLME, R, etc.

Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis. Great working knowledge of formulation development, drug development and clinical development.

Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.

Skills:

Must be able to apply scientific knowledge (in the areas specified above) to drug development, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.

Strong hands-on experience related to clinical pharmacology.

Strong organization skills.

Strong communication (verbal and writing) skills.

Flexibility to react rapidly to changing situations/environment. Travel 15%
Educational Qualifications

PhD, PharmD, MS in Clinical Pharmacology (or a related area such as Biomedicine, Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, Pharmaceutics) with a minimum of 4 years of industry experience in these areas.

Experience in population PK and PK/PD modeling and statistical models a plus.

Competencies Accountability for Results
- Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving
- Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity
- Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication
- Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration
- Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development
- Play an active role in professional development as a business imperative.

Minimum $ - Maximum $, plus incentive opportunity:
The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job…