Senior Director, Clinical Research Scientist

Hiring By - Biostaffic

 BioPharma

Cambridge, Massachusetts - United States

Job Highlights

Not Disclosed

Director

Posted 4 months ago
Job details
Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. We have developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Our pipeline includes XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors and Media” section of its website at www.mersana.com.
Our experienced management team shares a strong commitment to scientific excellence and patient care, while also cultivating a highly collaborative and welcoming workplace.
What’s in it for you?
We have an exciting opportunity for a highly motivated individual 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 collaboration 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 Committees, 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 understanding 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 strong interpersonal communication (written and oral) skills and ability to collaborate across disciplines.
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.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Cambridge, Massachusetts - United States

Experience:

  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
Mersana Therapeutics
Mersana Therapeutics

Current Openings: 0

At Mersana, we have a passion for advancing therapies to make a significant impact in the lives of people living with cancer. Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2).
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀