Senior Director, Clinical Operations

Location
South San Francisco, CA, United States
Posted
Jun 13, 2021
Ref
5045141002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

This position is a strategic leadership role, reporting to the VP Development Operations, is accountable for leading Sana's CAR-T programs, including all operational activities and cross-functional trial activities, and managing study management. This role is responsible for strategic planning & oversight, delivery of all operational activities in accordance with the Clinical Development Plans (CDPs) and in accordance with GCP guidelines, line management including recruiting, building, and maintaining a best-in-class Study Management staff.

DUTIES AND RESPONSIBILITIES
  • Manage all operational and strategic operational aspects of assigned programs
  • Own recruitment and oversight of Study Management for Sana's CAR-T programs
  • Give input to Development activities for assigned studies
  • Contribute to resource strategy for assigned programs
  • Collaborate in the development of the target product profiles (TPPs) and CDPs by generating scenario plans, high-level forecasting of timelines, assessing global program-level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
  • Handle unique challenges and decisions that have an impact on programs and disease area.
  • Develop and communicate budget, resource, risks and timelines to review bodies
  • Operate at strategic level including input into risk management plans, value assessment and therapeutic area/indication expertise. Long-range planning horizon is typically 2 or more years
  • Provide program leadership with oversight, guidance, and expertise to all staff assigned to the clinical program
  • Coach and mentor Study Team Leaders and Clinical Trial Managers assigned to program on trial leadership activities and appropriately delegates development opportunities
  • May serve as a team lead on non-program/ functional initiative work streams
  • Develop good relationships with all important partners. Contribute at Core Team level beyond operations and able to give input into Development strategy
  • Member of Development Operations Leadership Team
  • Help hire and source strategy and improve resources
  • Be a primary consultant to senior-level colleagues (eg, Project Team Leaders, Leaders & Medical Directors), functional leadership and stakeholders
  • Work is accomplished independently with oversight from VP Development Ops to ensure understanding of broad disease and organizational strategies
  • Lead and foster an environment supportive of innovation and smart risk-taking to bring and implement novel approaches to drug development
  • Lead staff through organizational change and growth and provide input to senior management on changes and improvements
  • Champion change with direct reports, dotted line reports and peers to sustain long-term goals
  • Demonstrate Sana's core values and the attributes that support these core values (Lead from every seat, Thrive as a team, Make it happen)
  • Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
  • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
  • Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
  • Innate ability to assess talent that will help grow the organization and add Sana's culture

QUALIFICATIONS

Basic Qualifications
  • Bachelors (preferably in a Life Science or Business discipline) or equivalent
  • 8 years industry experience with specific experience in Lymphoma or CAR-T trials
  • Deliver information in a manner that is appropriate for the audience
  • Display success working within a change management culture while managing multiple projects
  • Successfully manage conflict and foster positive working relationships with others
  • Must be well organized and able to provide senior operational support across multiple ongoing trials or a program
  • Knowledge of regulatory requirements relative to GCP's, adverse event reporting, and knowledge of FDA regulations
  • Proven track record showing excellent clinical project management skills including clinical supply logistics and managing to approved budgets
  • Experience with clinical operations in relation to clinical development functions
  • Experience with all aspects of clinical protocol design and implementation & overall drug development
  • Ability to interface with medical personnel at clinical site(s) and also lead multi-disciplinary teams both internally and externally, experience in strategic planning,
  • Experience understanding and critically assess the global clinical development plans, protocol design, resources needs and timelines for programs.
  • Strong financial knowledge with experience managing clinical program budgets
  • 2+ years of experience in clinical program management or a directly related role
  • Motivate and inspire while applying strategic project management skills at all levels of an organization
  • Drug development leadership experience, including history of effective management of teams thru phase 1-3 drug development and regulatory submissions (NDA/BLA/MAA).
  • Drive data-driven strategic planning and implementation, while engaging team to work towards goals, and on target
  • Experienced management of drug development budgets and fiscal responsibility
  • Effectively manage vendors across a variety of therapeutic areas
  • Help with building infrastructure for the Clin Ops department, including SOPs, processes, inspection readiness
  • Ability to travel as required
  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19

Preferred Qualifications
  • Start-up experience
  • Experience managing direct reports


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job description listed above is representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

The Company is committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short and long term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.