Vice President, Head, Nonclinical Development

Primary Responsibilities:

• Fully accountable for building and overseeing the nonclinical/translational strategy for company programs. Responsible for the design and execution of nonclinical (safety/toxicology, bioanalysis, PK/PD/ADME) plans to efficiently advance molecules at all stages of drug development; including non-GLP and GLP-compliant studies
• Build the nonclinical development function with the requisite scientific, safety/toxicology, PK/ADME and regulatory expertise
• Guide early clinical dosing strategy by integrating relevant nonclinical data
• Work in close collaboration with the Lycia Leadership team and project team leads, 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
• May also support clinical pharmacology activities for development programs
• 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 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 antibody drug conjugate candidates from research through development (resulting in successful INDs and/or BLA/NDA/MAAs).
• Strong knowledge of 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
• 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.