Position Summary
Highly motivated, creative scientific leader to advance our pipeline of LYTAC degraders and help establish Lycia as the industry leader in endosomal-lysosomal degradation and delivery. This role leads both clinical pharmacology and nonclinical sciences, integrating PK/PD, exposure-response and dose-selection strategy with translational science and toxicology strategy across the pipeline. A successful candidate can effectively work cross-functionally and has a strong drug development track record of advancing programs from target discovery through IND/clinical stage.
Primary Responsibilities:
- Fully accountable for building and overseeing the clinical pharmacology and nonclinical translational science strategy for company programs. Responsible for the design and execution of nonclinical (safety/toxicology, bioanalysis, PK/PD/ADME) and clinical pharmacology (PK/PD modeling, exposure-response, dose selection) plans to efficiently advance molecules at all stages of drug development; including non-GLP and GLP-compliant studies
- Build the clinical pharmacology and nonclinical development function with the requisite scientific, safety/toxicology, PK/ADME, clinical pharmacology and regulatory expertiseOwn clinical pharmacology strategy across the pipeline, including PK/PD modeling, exposure-response analysis, and dose/regimen selection for first-in-human and later-stage clinical trials, integrating relevant nonclinical data
- Work in close collaboration with the Lycia Leadership team and project team leads, Research group, contract research organizations (CROs) and external consultants to advance multiple drug candidates into and through clinical development
- Serve as a departmental representative and/or project leader for pipeline programs
- Partner closely with Clinical Development and Biomarker/Translational Medicine to align clinical pharmacology strategy with study design, biomarker strategy, and label-enabling endpoints
- Ensures timely, clear and accurate communication and interpretation of study results to facilitate productive discussion and effective decision making
- Coordinate and contribute to the preparation of documents required for regulatory meetings and submissions
- May serve as the company representative or subject matter expert in meetings with external stakeholders (business partners/collaborators, vendors, investigators, regulatory agencies)
- Maintain a current understanding of drug development and translational science literature and methodology relevant for the advancement of drug discovery projects
- Member of scientific leadership team that will work effectively and collaboratively with other departments and cross-functional teams, and contribute to building a positive, team-oriented culture
Qualifications:
- Requires a Ph.D. in clinical pharmacology, toxicology, pharmacology or other pharmaceutical or biological science
- 10+ years of industry experience beyond postdoctoral work in drug development and 5+ years of successful functional area management/ leadership
- Experience and accomplishment in progressing large molecule, small molecule, and/or antibody drug conjugate candidates from research through development (resulting in successful INDs and/or BLA/NDA/MAAs).
- Strong knowledge of clinical pharmacology and nonclinical drug development, FDA and ICH guidelines and GLP/GMP regulations
- Experience in designing, conducting and interpreting nonclinical pharmacology, PK/PD/ADME and toxicology studies
- Direct experience in clinical pharmacology, including population PK/PD modeling and simulation, exposure-response analysis, and dose/regimen selection to support IND-enabling and later-stage clinical trials; experience authoring clinical pharmacology sections of regulatory submissions and interacting with FDA/health authorities on clinical pharmacology matters
- Experience in working with external CROs with timely and successful delivery of studies and well-written deliverables; experience collaborating and managing consultants in various areas of nonclinical sciences
- Understanding of CMC, QA, clinical and regulatory stages to effectively support nonclinical and project activities throughout development
- Experience in writing nonclinical sections of regulatory documents and direct interaction with the FDA/health authorities
- Demonstrated ability to build and lead high functioning, collaborative and driven teams (both internal and external), and mentoring direct reports and/or junior cross-functional colleagues as applicable
- Excellent strategic thinking, problem-solving and analytical skills
- Excellent written and verbal communication skills
- Ability to build collaborative relationships both internally and externally
- Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff
- Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes
