At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.

DICE Therapeutics is seeking to recruit a Senior Medical Director/VP of Clinical Development to provide strategic leadership of DICE pipeline programs and oversee one or more clinical development programs. This individual is responsible for the planning and execution of clinical studies to move programs from IND/CTA through to later stage trials. This individual will work closely with cross-functional teams to develop innovative and efficient solutions to medical and scientific clinical trial issues, and in ensure the successful design, analysis, and completion of clinical trials. In addition, this individual will play a leadership role in the Clinical Development team and mentor or manage others in the Clinical Science function. Title will be determined based on the candidate’s experience.

Responsibilities:

  • Provides clinical, scientific, and strategic leadership for translational and early clinical projects, including leading early clinical-stage project teams
  • Responsible for the design, execution, analysis, interpretation, and presentation of clinical and translational studies
  • Provides medical oversight of clinical trials and works with cross-functional teams and external vendors and advisors to ensure the integrity of study conduct and patient safety
  • Collaborates with Research for target compound profile development to enable the success of future early development to IND decisions
  • Collaborates with Operations to ensure efficient and timely execution of the clinical studies while meeting all regulatory and ethics standards
  • Collaborates with drug safety to develop the product safety profile and with regulatory in the completion and submission of regulatory documents such as Investigator Brochures, IND, and CTAs
  • Plays a lead role in the planning, development, and implementation of external-facing communications strategies to support existing and concluded studies, including publications, advisory boards and other external presentations
  • Collaborates with CI to ensure up to date understanding of competitive landscape
  • Prepares literature reviews, external presentations, and publications as appropriate
  • Ensures adherence to established timelines and budgets while ensuring regulatory compliance and maintaining ethical standards
  • Ensures clinical and scientific awareness in area of expertise
  • Manage one or more direct reports and is, in such instances, responsible for hiring, training, developing, and retaining talent

Preferred Experience and Education:
Knowledge/Education:

  • MD or MD/PhD physician-scientist with strong understanding of translational disease biology in immunology and a track record of designing and executing early-stage trials;
  • Minimum 5+ years (Senior Medical Director) or 10+ years (VP) clinical development experience in industry

Job Experience:

  • A strong track record in team leadership, development of clinical-regulatory strategies, and/or industry-academic collaborations
  • Experience in immunology clinical trials required, early clinical development and phase I protocol writing experience.
  • Demonstrated ability to evaluate, interpret, and present complex scientific data, deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
  • Extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles
  • Management experience or the desire to develop as a manager, mentor, and leader of staff
  • Must be able to work independently and thrive in an entrepreneurial, fast paced, and dynamic work environment
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between functions and stakeholders.
  • Ability to work in a dynamic, high-pace environment and effectively manage change
  • Excellent interpersonal, verbal, and written communication skills.
  • Intellectually curious with strong critical, strategic, and analytical thinking skills
  • Training/board certification in dermatology, gastroenterology, and/or rheumatology or research experience in immunology preferred but not required
  • Interest and flexibility to work across multiple indications with high unmet need and ability to develop expertise in new disease areas quickly
  • Excellent presentation skills and ability to communicate effectively with senior management, internal and external partners
  • Travel up to 20%

DISCLAIMER
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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