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Senior Medical Director, Autoimmune Disease

Sana Biotechnology

Sana Biotechnology

South San Francisco, CA, USA
Posted on Wednesday, August 2, 2023

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 want to challenge status quo, and who lead with the desire to work on novel ideas. As a Sr. Medical Director for AI, you will report to the SVP, Clinical Sciences to provide broad scientific and/or medical input to activities that span across the scope of autoimmune disease clinical research, including contribute to/lead the strategic planning and execution of clinical research plans, provide medical support of regulatory submissions, contribute and provide medical input to commercial initiatives and medical affairs. Cool stuff.

What you’ll do

  • Medical oversight for planned and future clinical trials throughout- conduct and support of all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including interpretation of results, clinical study reports and graphical displays
  • Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials using CAR-T therapies in autoimmune diseases that benefit from B cell depletion therapy to support regulatory applications or future business/marketing objectives. This role will support ongoing planning for the development of cell-based therapies across autoimmune and oncology disease indications
  • Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents
  • Conduct and have oversight over medical monitoring activities and co-lead interactions with the Data Safety Monitoring Committee
  • Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate
  • Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization
  • Maintain close collaboration and cooperation with clinical operations on the implementation and execution of clinical studies
  • Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific data disclosures
  • Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
  • Serve as a medical interface to key opinion leaders (KOL), facilitating KOL advocacy development
  • Provide mentoring and coaching to more others across the company
  • Serve as medical monitor for clinical studies providing medical safety surveillance
  • 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

  • MD degree with a minimum of 5 years of combined medical practice and biotechnology or pharmaceutical industry experience in Clinical Research
  • Prior experience in Rheumatology, Immunology or Nephrology or relevant/related experience with board certification in one of these specialties
  • Deep understanding of and direct clinical experience in the treatment of autoimmune diseases such as SLE, autoimmune renal diseases and other potential diseases. Broad and deep understanding of approved and investigational therapies for these diseases
  • Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
  • Demonstrated ability as a medical expert in a complex matrix environment

What will separate you from the crowd

  • Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
  • General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data
  • Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
  • Prior industry experience as a medical monitor contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities preferred
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

What you should know

  • Ability to travel to other Sana sites, partnered sites, conferences and meetings as needed
  • Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
  • The base pay range for this position at commencement of employment is expected to be between $280,000 and $340,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

  • 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.