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Vice President / Senior Director, Clinical Development Req# 2043

Company: Encoded Therapeutics
Location: San Francisco
Posted on: February 25, 2021

Job Description:

Vice President / Senior Director, Clinical Development Req# 2043 Clinical South San Francisco, California, United States Full time 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. The VP, 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. Provide strategic leadership and work 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. Closely collaborate with the global experts in each given field to ensure patient voice, clinical and value impact, and regulatory inputs are incorporated. Strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. This role will report to the CMO. 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
  • Manage and direct more than one clinical programs in development
  • Lead program teams to design and implement rare disease clinical studies to deliver on the strategic vision and address patient needs
  • Provide management and/or career mentorship to one or more direct reports (as needed)
  • 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 Requirements
    • MD degree or foreign equivalent
    • At least 8 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
    • Proven clinical development strategist with experience designing, implementing and conducting clinical trials
    • Knowledge of carrying out multiple types of trial designs, including knowledge of nuances in gene or cell therapy
    • 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
    • Ability to travel up to 20% Preferred Qualifications
      • 5+ years of experience in rare disease
      • Experience in neurology and epilepsy
      • Comprehensive benefits package, including competitive employer premium contributions
      • PTO, sick time and holiday pay
      • Generous Parental Leave program
      • Pre-tax medical and dependent care programs
      • STD, LTD, Life and AD&D
      • Team-building events
      • Fully stocked kitchen
      • Fitness center Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272. Encoded Therapeutics does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.

Keywords: Encoded Therapeutics, San Francisco , Vice President / Senior Director, Clinical Development Req# 2043, Executive , San Francisco, California

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