Exec. Dr. Clinical Operations bei Sana Biotechnology
Sana Biotechnology · Cambridge, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Cambridge
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As the Head of Clinical Operations, you will report to the Chief Medical Officer to provide strategic leadership for our clinical programs and cross functional activities. This Executive Director role is a key member of the Development Team and interfaces with the Sana Executive Team.
What you’ll do
- Manage all strategic and tactical operational aspects of assigned programs, including with external CROs
- Be a thought partner in defining our clinical development strategies, partnering closely with regulatory, medical, and CMC teams
- Drive smart, lean execution from scenario planning and forecasting to budget and resource allocation
- Perform tasks of Clinical Trial Manager and Clinical Trial Associate while recruiting and overseeing team members across projects in the Sana portfolio
- Build and lead a high-performing team of “scrappy,” mission-driven clinical operations professionals.
- Collaborate in the development of the target product profiles (TPPs) and compound development plans (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
- Develop and communicate budget, resources, risks and timelines to review committees
- Operate at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Long-range planning horizon is typically 2-5 years.
- Coaches and mentors Study Team Leaders and Clinical Trial Managers and appropriately delegates development opportunities, as needed
- May serve as a team lead on non-program/ functional initiative work streams
- Builds and maintains good relationships with internal and external key stakeholders. Contributes at Core Team level beyond operations and able to give input into Development strategy
- Leads and develops an environment supportive of innovation and smart risk-taking to drive and implement novel approaches to drug development
- Leads and supports staff through any organizational change and growth and provides input to senior management on potential organizational changes and improvements.
- 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 to Sana’s culture
What we’re looking for
- Bachelors (preferably in a Life Science or Business discipline) or equivalent with 10+ years industry experience
- Study start-up experience – “scrappy” and willing to be hands on for the entire development team. Includes coverage for teammates when warranted
- Strong knowledge of regulatory requirements relative to GCPs, 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
- Detailed understanding of all aspects of clinical protocol design and implementation, and overall drug development
- Ability to effectively interface with medical personnel at clinical site(s) and lead multi-disciplinary teams both internally & externally, proven experience in strategic planning
- Proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs and timelines for programs
- 2+ years of experience in clinical program management or a directly related role
- Significant drug development leadership experience, including history of effective management of cross-functional teams through phase 1-3 drug development and regulatory submissions (NDA/BLA/MAA). Lifecycle experience preferred
- Proven ability to lead and influence data-driven strategic planning and implementation, including the ability to focus a team to work towards its goals effectively, efficiently and on target
- Desire to shape a Clinical Operations organization for future success
- Ability to travel as required
What will separate you from the crowd
- Experience leading small teams that can grow over time
- High degree of accountability
- Willingness to participate in day-to-day, hands-on tasks while team is being built and beyond
- Strong skills in: communication, both oral and written; presentation and meeting leadership; coaching and personnel development
- Ability to deliver and present clear messages to teams, various functional areas, and senior leaders
- Demonstrates excellent communication (written and verbal), presentation and interpersonal skills
- Displays ability to lead and innovate successfully within a change management culture and fast-paced environment
- Successfully manages conflict and fosters open communication with others
- The ideal candidate will have experience with cell therapy and diabetes or endocrine product development
- Must be well organized and able to provide senior operational support across multiple ongoing trials or a program
- Knowledge of industry trends, tools and partners that will help us stay ahead
What you should know
- The base pay range for this position at commencement of employment is expected to be between $275,000 - $350,000 annually ; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
- Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
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.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.
We are 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, social class (including caste/caste identity), 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.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
