Associate Director /Director, Clinical Program & Operations Management

Location
South San Francisco, CA
Posted
Jun 03, 2022
Ref
61039
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time

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.

Essential Functions:

This is a key strategic role accountable for the development and delivery of DICE’s clinical programs. In addition, as a member of the Clinical Operations Leadership team, you’ll help to define and implement the vision for forming a high-quality Program & Study Management group. You will have functional management responsibilities including recruiting, developing and retaining a talented team of Trial Managers /Associates.

Key Program-level Responsibilities:

  • Serves as the key Clinical Operations partner supporting the Development Core Team, building and driving global operational strategies for the Clinical Development Plan of one or more programs; provides innovative and flexible operational solutions, has the ability to understand, critically assess and influence development plans, including: protocol design, resource needs, global budgets and timelines for programs
  • Leads all aspects of trial activities at the program-level; provides disease area expertise and input while maintaining awareness of potential changes in the disease landscape (e.g. standards of care /regulations) that could impact operational strategies
  • Engages with Key Opinion Leaders and Scientific Advisors to design quality clinical trials
  • Directs Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs) to meet program objectives for timely initiation and execution of clinical trials
  • Contributes to protocol development and provides direction, as needed, in the development of study plans and documents
  • Provides program-level oversight of CRO and 3rd-party vendors, serving as a mentor and a point of escalation for CTMs /CTAs, as required
  • Accountable for adherence to SMT-approved budgets and timelines; provides routine reporting for assigned programs (budget, timelines, issues and risks) to Clinical Operations leadership
  • Participates (as needed) in the review of clinical data in the EDC, data listings, or report tables; ensures that all study data and documentation from investigational sites meets FDA/GCP/ICH regulations, and that studies are carried out according to the study protocol, SOPs, study-specific manuals and procedures, as well as DICE quality standards
  • Accountable for quality /risk management oversight related to assigned programs
  • Provides program-level leadership /input to stakeholders across DICE, including Finance, Vendor Management, etc.
  • Fully understands the need for and importance of being inspection ready and diligently follows all DICE SOPs; identifies and communicates if there are gaps
  • Key Functional Management Responsibilities:

  • Upholds DICE’s positive culture and work environment by advocating and proliferating mutual respect, trust and transparency
  • Provides leadership, mentorship/development for 5-6 direct reports, administering performance management programs in accordance with DICE policies
  • Participates in recruiting /hiring /retention activities, including group resource management
  • Contributes to the development of a first-class Clinical Operations group: ensures that employees are effectively trained, coached and developed, expands their knowledge of clinical trial  operations and scientific principles
  • Leads initiatives to propagate best practices in clinical operations methodologies, systems and processes, and knowledge management with particular emphasis on quality, time standards and expectations
  • Proactively contributes innovative ideas to influence and challenge current business practices and/or enhance the efficiency and effectiveness of Clinical Operations
  • Completes a variety of other Leadership-related responsibilities as assigned and agreed upon with functional manager, including chairing Clinical Operations group meetings
  • Travel required: potential domestic and international travel
  • Preferred Education, Experience and Skills:

  • Bachelor’s degree in scientific field, or equivalent training and experience
  • Minimum of 10 years (AD) /15 year (Dir) of direct Clinical Operations experience, including at least 3 years in Program Management role (Sponsor)
  • Minimum 3 /5 years functional management experience
  • Early Development and Immunology experience strongly favored
  • Exceptional knowledge of Good Clinical Practices (FDA and ICH), and a solid understanding of 21 CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, eTMF requirements and ICH E-6(R1& R2) expected
  • Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing workplace law required
  • Proven ability to manage multiple projects while maintaining quality is required
  • Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders
  • Strong attention to detail, excellent communication and organizational skills
  • Able to proactively identify logistical problems and propose solutions
  • Treats colleagues with respect; inspires the trust of others; works with integrity and ethics; maintains DICE organizational values, leads by example
  • Is a true team player; gives and welcomes feedback; contributes to building a positive team spirit; supports other's efforts to succeed
  • Strong computer skills required including MS Office (Word, PowerPoint, MS Project), including a high-level proficiency /expertise in Excel
  • Position is based in South San Francisco, with potential for flexible work arrangements  
  • 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.