Director, Clinical Development

Location
Redwood City, CA, United States
Posted
Apr 23, 2021
Ref
1990418427
Hotbed
NextGen Bio
Required Education
Masters Degree/MBA
Position Type
Full time
JOB SUMMARY:

The Director, Clinical Development will lead or contribute to the design and implementation of overarching clinical and scientific strategies for the development of one or more gene therapy programs. This position requires strategic leadership and the ability to drive collaboration with cross-functional team members to integrate unique perspectives into clinical development plans that deliver gene therapies of value to patients, healthcare practitioners, and payors. We are seeking highly-motivated individuals, capable of working independently or as part of collaborative, cross-functional team, and passionate about bringing potentially transformative medicines to patients in need.

PRIMARY RESPONSIBILITIES:

• Support the strategic management of cross-functional integrated gene therapy development plans, including the creation and/or execution of end-to-end clinical development plans.
• Lead or contribute to the design and development of high-quality clinical trials and associated study documents (e.g., clinical protocols, investigator brochures, informed consent, clinical study reports, regulatory submissions).
• Provide clinical and scientific oversight of clinical trial implementation to assure study results provide data necessary to adequately address questions related to the safety and efficacy of a gene therapy product, as well as applicability to the targeted study population.
• Proactively identifies potential program development risks and actively contributes to the development of mitigation plans
• Represent Clinical Development is cross-functional project teams, process improvement teams, or organizational initiatives, as needed.
• Engaging and influencing a diverse range of clinical/scientific external experts (e.g., consultants, investigators, regulators, payors) to assure clinical program objectives are aligned with business strategies and patient needs.
• Author or critically review scientific publications, including abstracts, posters, manuscripts and external presentations.
• Supports Business Development in the clinical/scientific assessment of potential in-licensing opportunities, as needed.

EDUCATION/EXPERIENCE REQUIREMENTS:

• Significant experience in clinical drug development, with a strong understanding of underlying disease biology, therapeutic targets, unmet needs, and competitive landscape. Prior experience in ophthalmology strongly preferred.
• Previous experience in the clinical development of gene therapies a plus, but not required.
• Demonstrates advanced understanding of required steps to progress a drug to human clinical trials, as well as experience in the design, development, execution, analysis and reporting of high-quality clinical studies.
• Experience leading matrix teams with a reputation for motivating high performance
• Demonstrates the ability to ensure clinical studies are conducted according to Good Clinical Practice (GCP)/International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, regulatory requirements, and internal control documents.
• Ability to work independently and as part of a cross-functional, collaborative team.
• Outstanding written, verbal, and interpersonal communication skills.
• Advanced scientific or clinical degree preferred (MS, PharmD, PhD, DO, or MD).
• 10+ years of clinical research experience, including at least 5 years of clinical development experience within pharmaceutical industry or biotech organizations.

WORKING CONDITIONS:

• Domestic and international travel may be required (approximately 10-15%)

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics' fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.