Director/Sr. Director Toxicology

Toxicology Cambridge, Massachusetts


Description

 What’s in it for you?

In this role, you will have an opportunity to join Mersana at a time of growth and learn about the proprietary scientific platform used to develop our novel ADCs, working closely with our discovery and development colleagues to help guide our molecules along the pipeline by overseeing and driving our late discovery/early development safety assessments as well as supporting the on-going development of our clinical pipeline. In this role you will have accountability for projects across the continuum of Discovery and Development, and by continuing to cultivate input from our established external expert consultants, become our internal translational safety expert.

How do you know if you’re the right fit?

If you are a highly self-motivated, driven individual who enjoys the challenges and opportunities available in a growing and transforming organization, this will be an opportunity for you to apply yourself, share your expertise, and learn and deliver.  You’ll thrive in an environment where you are involved in both the strategy (the bigger picture) and in the execution, and value proactive collaboration and teamwork. 

To be successful, you will have previously gained experience in both biologics and small molecules (ADC experience would be desirable) preferably in an oncology setting, and will have been responsible for development of non-clinical safety strategies, maintaining effective CRO relationships and the execution of toxicology/TK studies at CROs. You will also need to be highly effective in your verbal and written communications and have effective engagement with cross functional teams.

In this capacity you will both set a strategy, oversee the agreed project plans and be responsible for the toxicology budget. You will need to be able to interpret and offer critical review of returned reports in terms of toxicology and pathology findings, provide presentations to the team and leadership on the data’s impact, and be able to translate these to write critical contributions for key regulatory documents.

Your experiences to date will have spanned along the range of the following areas, as we are seeking the following attributes:

  • Oversee all aspects of translational safety sciences, able to engage with the biologists and pharmacologists through to discussing the clinical safety findings with the clinicians and so look to build an overall integrated understanding of safety for our novel ADCs that can be translated back for the benefit of new assets in discovery. 
  • While veterinary pathology training is not a prerequisite for this role, a sound understanding of this discipline and key principles is expected, such that pathology reports can be reviewed, the findings summarized, and relevance explained in written summaries.

 

  • Develops and communicates the non-clinical development strategy within the company while being comfortable in seeking guidance and input from internal (i.e. biology, pharmacology, chemistry, DMPK and clinical functions) and external stakeholders such as the scientific advisory board and key consultants.

 

  • Have excellent written communication skills and so be responsible for authoring of toxicology sections of an IND and other regulatory documents and accountable of their quality in support of regulatory submissions (INDs and BLAs)

 
The other stuff

This role reports to the Chief Science and Technology Officer.  At this stage, the role will be an individual contributor, working with matrixed functions; future growth of the company may result in the opportunity to oversee direct reports. There will also be an opportunity to engage, learn and contribute to other aspects of the broader non-clinical development effort.

 This is typically a role best suited for (Masters with at least 12 years of experience or Ph.D. with 9 years of experience) who possess at least (8) years’ pharmaceutical/biotechnology experience (or other). 

  • Capable of working independently within a highly matrixed organization
  • Experience with external vendor management such as CROs and consultants
  • Excellent verbal and written communication skills

 This position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.

 The successful candidate must be authorized to work in the United States.

 Mersana Therapeutics, Inc. is an equal opportunity employer.