Clinical Development Director
4 days ago
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.
Job Summary: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.
Key Responsibilities:- Develop and implement clinical development strategies to support the company's mission and goals.
- Lead cross-functional teams to design and implement clinical studies, including protocol development, investigator brochures, and clinical study reports.
- Collaborate with external stakeholders, including key opinion leaders, clinical investigators, patient advocacy groups, and regulatory agencies.
- Provide medical support as needed on company and non-company sponsored studies, non-interventional studies, and investigator-sponsored studies.
- Develop and maintain relationships with vendors and external partners.
- Stay up-to-date with regulatory requirements and industry trends to ensure compliance and competitiveness.
- 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%.
- Competitive salary range: $194,000 - $226,000.
- Annual bonus and equity under the company's stock plan.
- Comprehensive benefits package, including competitive employer premium contributions.
- Meaningful stock option grants.
- PTO, sick time, and holiday pay.
- Generous Parental Leave program.
- Pre-tax medical and dependent care programs.
- STD, LTD, Life and AD&D.
- Professional development opportunities.
- Team-building events.
- Fully stocked kitchen.
- Purple Tie dry cleaning service.
- Fitness center.
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