Associate Director, Clinical Development

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

The Associate Director, Clinical Development creates the overall program strategy for early development/first-in-human through life cycle management and developing and overseeing the execution of the clinical study portfolio designed to meet objectives of a novel platform in gene regulation. He/she provides strategic leadership and works closely with cross-functional leadership that includes Research, Clinical Operations, Regulatory, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. He/She closely collaborates with the global experts in each given field to ensure patient voice, clinical and value impact, and regulatory inputs are incorporated. He/She is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. This role will report to the Head of Clinical Development.

Workplace Model: Remote

Responsibilities

• Serve as a key leader of the R&D organization and provide clinical development advice and counsel to Encoded governing and oversight bodies as needed
• Create specialized strategies blending known and effective pathways with ability to incorporate innovative approaches in rapidly changing regulatory environment
• Able to manage and direct more than one clinical program in development
• Lead program teams to design and implement rare disease clinical studies to deliver on the strategic vision and address patient needs
• Select and manage close relationships with multiple vendors
• Oversee development of protocols in close cross functional and external collaborative manner
• Oversee key documents in clinical programs: investigator brochures, clinical study reports and review clinical trial documents
• Maintain and develop relationships with key opinion leaders, clinical investigators, patient advocacy, outcomes experts, and other instrumental external stakeholders
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Provide insight to pipeline determination in clinical feasibility, and translate findings from research and nonclinical studies into clinical development opportunities
• Provide clinical leadership and work in a team environment in interactions with external stakeholders and internal stakeholders
• Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies, including medical monitoring
• Perform other duties as required

Requirements

• MD degree or foreign equivalent with greater than 2+ years’ experience in a rare disease preferred
• 5+ years of experience within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
• Knowledge of nuances in gene or cell therapy
• Knowledge or experience in neurodevelopment and key developmental tools preferred
• Strategic leadership and communication skills, strong initiative, ethics, and judgment, and demonstrated ability to positively represent the goals of Encoded
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Ability to collaborate with scientific/technical personnel, commercial and medical affairs
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Excellent written and oral communication skills, including presentation skills
• Possess an understanding of applicable US and EU drug development regulations and GCP regulations
• Experience in child and adolescent psychiatry, developmental pediatrics, or in pediatric neurology strongly preferred
• Able to travel up to 30%

The anticipated salary range for candidates who will work Remote is $194,000 - $226,000. The final salary offered to a succe