Senior Director, Toxicology - CART Cell Therapies
Company: Sana Biotechnology
Location: Cambridge
Posted on: May 12, 2022
Job Description:
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 Senior Director/Executive
Director, Toxicology - CART Cell Therapies, you will report to VP
Toxicology, Pathology, & Biodistribution to oversee the
non-clinical development and advancement of our cell therapy
portfolio into the clinic and bring strategic input to Senior
Management to align and advance corporate goals and milestones. The
qualified candidate is a highly motivated, interactive, and
creative individual that has demonstrated expertise in drug
development to work across a highly matrixed environment to advance
translational efforts. This role is integral to driving discovery
research into the clinic, including exploratory, pilot, and pivotal
toxicology studies and health authority interactions. The candidate
must possess a demonstrated ability to apply critical thinking to
solve complex problems to craft customized preclinical strategies
for novel therapeutics. This person is responsible for the overall
strategy and conduct of the studies supporting a Project Team and
is thus an expert on study process and specialist needs for cell
and or gene therapy products. The candidate will be expected to
work collaboratively within Development Sciences and to liaise
closely with the Project teams to develop safety strategies for
advancement to the clinic. What you'll do
- Lead the safety strategy for Project and Core Teams by solving
complex problems to craft customized solutions for multiple novel
CART-based therapeutics
- Work collaboratively with Research (internal and external
partners), Pharmacology, Pathology, CMC, Bioanalytical scientists,
Translational and Clinical Sciences to progress therapeutics
through the pipeline from discovery to launch
- Provide internal expertise to understand the mechanisms of
toxicity observed non-clinically and/or clinically to drive
mitigation and/or back-up strategies to minimize potential harm to
patients
- Present data and interpretations in written and oral form to
Project Teams, Research & Development Committee or Senior Executive
Team (as needed)
- Liaise with Associate Director of Non-clinical Operations and
internal Sponsor Representative/Study Monitor to build and maintain
effective CRO relationships for the execution of studies including:
contracting, management/oversight and monitoring of studies at
CRO's
- Write regulatory summaries for safety pharmacology,
biodistribution, and toxicology data sets for submissions in the US
and ex-US (eg. IND, CTA, BLA, briefing books, Investigator
Brochures etc)
- Working knowledge of code of federal regulations (eg. CFR 21
Part 11 and Part 58 etc) and regulatory guidance's (eg. FDA, EMA,
ICH etc) as it pertains to the strategic planning and conduct of
safety packages to support first-in-human (FIH) testing
- Build collaborative networks both internal and external to the
company to ensure rapid communication and cross-functional
evaluations and investigation
- Represent SANA Bio in the external scientific environment
- 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 What
we're looking for
- PhD or DVM and 10+ years of experience in immuno-oncology in a
pharmaceutical/biotech setting
- Demonstrated subject matter expert in development of
immuno-oncology or CART-cell therapies with demonstrated ability to
work with abstract ideas or situations across functional areas of
the business
- Prior role in multidisciplinary projects and teams with
demonstrated ability to successfully integrate cross-functional
information to support the functional area and deliver on the
business strategy and company goals
- Demonstrated ability in developing and implementing safety or
pharmacology strategies for teams including species selection,
biodistribution, target organ identification, and selection and
justification of maximum tolerated dose or NOAEL across different
therapeutic areas or modalities, e.g. biologics, cell or gene
therapies
- Strong executive communication skills, awareness of how to
negotiate, and conduct crucial conversations to solve complex
problems
- Strong scientific writing skills to prepare and review
non-clinical sections (eCTD Modules 2.4 and 2.6) for IND or CTA
submission, preparation of briefing books (Interact or Pre-IND),
Investigator Brochures, BLA etc
- Strong collaboration and relationship building and
decision-making skills
- Working knowledge of regulatory needs for conduct of both
non-GLP and GLP studies
- Familiarity with presenting strategy to teams or management,
aligning and achieving buy-in for strategic approach including
risk-based approach What will separate you from the crowd
- PhD in pathology, comparative biology, molecular pathology,
immunology, virology, or a related field
- Familiarity with developing/advancing safety or preclinical
strategies for cell and gene therapies to enable project teams
- Demonstrated skills in critical thinking, problem solving, and
mechanistic investigation evidenced by scientific publications or
presentations a plus What you should know
- Some travel may be expected to visit with Sana colleagues at
other sites, external collaborators, contract laboratories, or for
regulatory meetings
- 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 be fully
vaccinated against COVID-19, including receipt of a vaccine booster
shot if recommended by the CDC 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, 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. 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.
Keywords: Sana Biotechnology, Cambridge , Senior Director, Toxicology - CART Cell Therapies, Executive , Cambridge, Massachusetts
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