Sr. Director/Exec. Director, Translational Medicine
South San Francisco /
Development /
Full-Time
/ On-site
Lycia Therapeutics, Inc. is a biotechnology company leveraging its lysosomal targeting chimera (LYTAC) platform from Founder and Chemistry Nobel Laureate 2022, Carolyn Bertozzi, to discover and develop first-in-class therapeutics that degrade extracellular and membrane-bound proteins. Lycia’s next generation degraders harness the cell’s endogenous lysosomal trafficking and degradation machinery with the potential to degrade targets previously considered to be intractable, across a spectrum of indications. After raising $105 million in capital in 2021, Lycia is advancing an internal pipeline of novel degraders and has entered a strategic collaboration with Eli Lilly to address key unmet medical needs. Lycia is headquartered in South San Francisco.
We are looking for a highly motivated and experienced translational/clinical development leader to advance our pipeline of LYTAC degraders from preclinical/IND stage to clinical POC and possibly, later stages of development. Ultimately reporting to the Chief Medical Officer (currently, to the Chief Executive Officer), this role will be a unique opportunity to help build and shape the translational/clinical development group at the company. This position will partner closely with all Research and Development groups on advancing the pipeline and new target evaluation. A successful candidate has a demonstrated scientific understanding of underlying biology/mechanisms and a strong drug development track record of advancing programs from preclinical/IND to clinical POC across multiple human disease areas.
Key Responsibilities
- Design and execution of FIH/early clinical strategies for programs from pre-IND to clinical proof-of-concept, including making recommendations regarding endpoints, study design, safety evaluations and dose selection
- Define and develop integrated development plans, including the assessment of medical need, clinical development pathways and review of preclinical/pharmacology data for translatability, target drug profiles
- Identify and seek to validate novel endpoints and/or biomarkers for early decision making; identify patient or target population stratification strategies to support rapid demonstration of safety and efficacy
- Provide clinical leadership to early development project teams, including serving as a key representative for both internal and external constituents (e.g., CRO, data monitoring committees, clinical trial sites, consultants)
- Support global regulatory strategy and responsible for the generation of investigator brochures, IND/CTA documents, clinical protocols and other regulatory documents as appropriate
- Maintain an understanding of competitors and developments in relevant disease areas by attending scientific meetings, developing relationships with KOLs, and tracking literature; proactively communicate learnings and program impact to management
- Cultivate and maintain a network of external KOLs
- Ensure seamless transition between research and clinical development by partnering with all relevant teams/functions (including external consultants) to shape and define the development strategy for hypothesis-based experimentation with maximal value creation
- Participate in new target and disease area evaluations, including translational biology assessment and hypothesis for mechanism differentiation within context of competitive landscape
- Balances creativity and risk-taking with drug discovery/development considerations in the design and execution of program strategies to ensure successful achievement of corporate and scientific objectives
- Member of R&D leadership team that will work effectively and collaboratively with other departments and contribute to building a positive, team-oriented culture
Required Education and Experience
- Requires a M.D., M.D./Ph.D. or equivalent medical degree
- Minimum 5+ years of relevant industry experience in translational medicine and clinical development, ideally with biologics
- Strong understanding of and proven drug development experience in immunology and inflammatory diseases
- Leadership of cross-functional drug development teams
- Demonstrated success in advancing programs from preclinical/IND stage through various stages of development, including the design and conduct of clinical studies
- Demonstrated ability to lead high functioning, collaborative and driven cross-functional teams
Additional Qualifications
- Excellent written and verbal communication skills
- Values cross-functional collaboration, scientific diligence/rigor and diverse perspectives to inform rigorous decision making
- Must be able to effectively work in a fast-paced, dynamic and high-growth environment with demonstrated ability to manage multiple competing priorities with a high degree of self-motivation
- Demonstrated consistency and excellence in independent management of complex, major projects/programs
- Has proven leadership qualities consistent with scientific excellence, demonstrating flexibility and an ability to drive go/no go decisions, and valuing transparency in communication
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status
