Director/Sr Director Drug Metabolism and Pharmacokinetics (D

Company: Mersana Therapeutics, Inc
Location: Cambridge
Posted on: February 20, 2021

Job Description:

In this role, you will have an opportunity to drive the DMPK strategy for Mersana's ADC projects across our Discovery and Development pipeline. You will be the company's DMPK subject matter expert and will need to from close partnerships with the other nonclinical functions such a toxicology, biology, pharmacology and chemistry along with the development and clinical groups. This would impact Mersana by ensuring DMPK strategies are decided and the key studies executed, and the data delivered that goes to support our INDs and BLAs. You will have the opportunity to work in cross-functional teams and develop your expertise across the full drug development continuum, by being part of a combined nonclinical and clinical department. To be successful, you will have previously will be responsible for building and maintaining effective CRO relationships that support the execution of clinical and non-clinical ADME/PK work. In this capacity you will be responsible for agreeing projects of work and negotiating costs and setting the outsourced DMPK budgets. You will also be able to interpret the returning data, provide presentations to the team and leadership on the data's impact and be able to write summaries for key regulatory documents. This role reports the head of Clinical Pharmacology and Bioanalytical Sciences. At this stage the role will be an individual contributor, needing to work with matrixed functions, though future growth by the company may result in the opportunity to oversee direct reports. 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, 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. Additionally, your input will be expected to span the needs for both discovery and development and the opportunity to engage and learn about the other aspects of the broader Clinical Pharmacology discipline will be available.-- Your experience will span along the range of the following responsibilities:

• Provides overall strategy and direction for non-clinical DMPK processes and procedures in support of both discovery and development
• Be an active participant in project teams as well as collaborating with discovery and clinical development partners to identify and solve issues related to drug safety
• Communicates the DMPK development strategy within the company while seeking guidance and input from internal stakeholders
• Ensures an agreed DMPK development plan for discovery and clinical development assets
• Be responsible for authoring of DMPK sections on an IND and accountable of their quality in support of regulatory submissions
• Responsible for the scientific and budgetary oversight and coordination of external vendors and consultants and so deliver on all programs DMPK study and data needs --The other stuff This is typically a role best suited for (Msc with 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 high matrixed organization
  • Experience with external vendor management such as CROs and consultants
  • Excellent verbal and written communication skills Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays. Successful candidate must be authorized to work in the United States. Mersana Therapeutics, Inc. is an equal opportunity employer. You have been redirected to a Mersana Therapeutics, Inc. job page

Keywords: Mersana Therapeutics, Inc, Cambridge , Director/Sr Director Drug Metabolism and Pharmacokinetics (D, Executive , Cambridge, Massachusetts