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What’s in it for you?

We have an exciting opportunity for a highly motivated person to contribute to the development and execution of the clinical strategy for Mersana’s oncology programs. You will interact in close partnership with the organization and a cross-functional team of experts in Discovery, CMC, non-clinical and clinical development. This is an opportunity to make a visible impact through your strategic and scientific input as you use your scientific knowledge and experience to help build clinical expertise on the team and help drive the development of our assets. This position reports to the Executive Medical Director, Clinical Development.

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

Your experience will contribute to the following:

• Playing a major role in shaping and driving the clinical development process
• Providing regulatory and clinical program strategy, design, and execution including assessment of competitive and global regulatory landscape, endpoint selection, data management optimization, and protocol development
• Contributing to the design of clinical studies in close partnership with the Executive Medical Director, Clinical Development (MD) and the clinical development team
• Developing presentations and communicating study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences
• Authoring/reviewing clinical study documents in compliance with regulatory standards (protocols, informed consent documents, and clinical components of investigator brochures, INDs and NDAs)
• Providing clinical input on CRF design, statistical analysis plan and drug supply planning
• Performing and coordinating clinical data review and analysis of study results
• Reviewing and tracking efficacy and safety data, and taking actions as appropriate

• Preparing clinical content of regulatory submissions and documents e.g., Investigator’s Brochure [IB], Development Safety Update Report [DSUR]

• Performing and documenting regular review of individual subject safety data
• Preparing abstracts, posters, presentations, and publications
• In collaboration with other clinical functions assisting in arranging investigator meetings, scientific advisory boards, Data Monitoring and steering committees.

The other stuff

This is typically a role best suited for Ph.D., PharmD or Masters’ degree candidates with a scientific background and at least 8 years’ pharmaceutical/biotechnology experience in clinical research, and a strong knowledge of drug development.

In addition, the successful candidate will possess:

• A comprehensive understanding of all stages of drug development
• Clinical development experience within oncology

• Ability to contribute to the clinical strategy and create clinical development plans
• A thorough knowledge of FDA, GCP, ICH, and eCTD compliance standards, and relevant regulatory requirements
• Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents.
• Demonstrated ability to review and summarize study data, including experience in preparing and presenting data.
• Demonstrated strong analytical and strategic thinking skills.
• Demonstrated communication skills (written and oral) and ability to collaborate across disciplines.

The 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.

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