Senior Scientist in vitro pharmacology and biomarker discovery

Location
Cambridge
Posted
Sep 28, 2021
Ref
5486162002
Required Education
Associate Degree
Position Type
Consultant

About the role

Reporting directly to the Director of the In Vitro Pharmacology and Biomarker Discovery (IVPBD) group within the department of Development Sciences, the Sr. Scientist will be involved in pre-clinical characterization of lead Gene Therapy (fusogen) and Cell Therapy candidates, including IND-enabling studies. The Sr. Scientist will be leading in vitro efforts to support PD/PK and pivotal pharmacology investigations for cell and gene therapy programs. The Sr. Scientist will work with the Director of IVPBD to design and implement strategies involving primary immune cells to support various Gene and Cell Therapy research programs and to communicate with project team leads and Sana senior management as needed, and represent the IVPBD on project teams. You will be an action-oriented and scientifically rigorous key team member with a strong understanding of early drug development and IND enabling study expectations. You will contribute to writing Pharmacology sections for various regulatory submission, including INDs.

What you’ll do

  • Independently design and execute studies aimed to characterize PD/PK of lead Gene Therapy and Cell Therapy drug candidates
  • Support pharmacometrics and modeling simulations for lead drug candidates
  • Manage and coordinate scientific strategy and experimental timelines across projects within the In vitro pharmacology and biomarker discovery (IVPBD) group to meet project goals
  • Be responsible for communicating experimental data to project teams and other groups within company
  • Write relevant sections in various Regulatory submission packages, including
  • Liaison with cross-functional partners and executive leadership regarding project timelines and deliverables.
  • Collaborate with Development Science staff to outline goals, timelines and objectives in conjunction with Corporate goals
  • Act as an expert consultant and scientific resource in Pharmacology and PK/PD for the IVPBD group and relevant project teams across Cell Therapy and Gene Therapy
  • Work to create team-oriented, cooperative culture within the IVPBD group and foster relationships with other cross-functional groups and project teams across Sana

What we’re looking for

  • PhD in scientific discipline with at least 5+ years with laboratory experience with a minimum of 2 years of industry experience or a Masters' degree in a scientific specialty with a minimum of ten years of experience in industry and proven proficiency in independent research and in the design of laboratory experiments and techniques may provide the necessary experience.
  • Strong scientific background with early development experience and discovery-based research and significant in vitro and in vivo immunology experience
  • Experience in in vitro and in vivo study design, assay development and qualification to support PK/PD studies for cell and gene therapy modalities (preferably LV based)
  • Well versed in a wide array of cellular and molecular biology laboratory techniques (such as Flow cytometry, RT-PCR, ELISA/MSD etc.) and experienced in their use.
  • Strong experience with immune primary cells cultures and characterization (eg. PBMC, CD8/CD4 isolations, lukopack)
  • Scientific expertise in gene or cell therapy, ideally LV or AAV
  • Analytical and problem-solving skills, and ability and desire to learn complex issues
  • Deep scientific knowledge in Immunology and Pharmacology and the ability to use that knowledge and experience to address immune-related challenges across multiple therapeutic programs at Sana
  • Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, technical experts, computational biologists, cell biologists, and therapeutic teams.
  • Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams.
  • Must be able to effectively communicate with colleagues and associates outside the fucntion to create partnerships and collaborations

What will separate you from the crowd

  • Experience in authoring and reviewing IND applications and related documentation, critically reviewing technical documents, protocols and reports connected to assay development, validation and clinical sample testing, biomarker elements in regulatory submission documents.
  • Experience in vivo PK/PD for cell and/or gene therapy and QPS/modeling is highly preferred
  • Accustomed to working in a fast-paced, dynamic environment
  • Experience training and developing advanced scientific personnel

What you should know

  • Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19

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, 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.

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, 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.