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Clinical Research Scientist

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 
At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

About the role

As a subject matter expert within your areas of expertise and a key contributor in the emerging field of microbiome-based therapeutics, the Clinical Research Scientist (CRS) will partner with the Vice President of Clinical Research to provide scientific, clinical, strategic, and operational input to early- and late-stage clinical development programs. This role will work across a spectrum of clinical programs and therapeutic areas, becoming a trusted strategic partner of the R&D leadership team. Additionally, the CRS will help us deliver on Vedanta’s growing pipeline of novel treatments for patients with unmet medical needs by working with cross-functional study teams on the design, execution, and monitoring of clinical studies. The specific title, level of autonomy, and scope of the role will be commensurate with the level of experience the incumbent brings to the role.

Here’s What You’ll Do:

  • Utilize your clinical/scientific expertise to develop and advance the clinical strategy of your programs.
  • Develop expertise in the diseases we are studying and the applications, mechanisms, and clinical endpoints for studies of microbiome-based therapeutics.
  • Contribute across multiple projects and therapeutic areas.
  • Participate in study management and project teams to attain clinical development goals and achievement of study metrics related to time, budget, and quality.
  • Address scientific questions that arise and ensure there is ongoing oversight of safety during the conduct of clinical studies.
  • Ensure high quality data in clinical studies through participation in routine medical monitoring of accruing data.
  • Maintain appropriate level of medical oversight of Contract Research Organizations and other clinical study vendors.
  • Contribute to the development of other study and program documents including informed consent forms, medical monitoring plans, Data Monitoring Committee charters, Annual Safety Reports, etc.
  • Work with medical and scientific staff to review, summarize, interpret, and present on the safety, efficacy, pharmacokinetic/pharmacodynamic and patient-reported outcomes of clinical studies.
  • In collaboration with a senior clinician, co-author clinical and regulatory documents including protocols; clinical study reports; Investigator’s Brochures; training documents; regulatory responses, briefing books and reporting requirements; and components of INDs and submission dossiers.
  • Contribute to the design and execution of organizational initiatives conducted in support of development programs.
  • Along with project teams and stakeholders, contribute to the organization, preparation, and execution of Investigator Meetings, Steering Committee Meetings, and Advisory Board meetings.
  • Remain up to date on current information regarding the competitive landscape, regulations, guidelines, and scientific advances in the relevant fields.
  • Cultivate relationships with external partners such as clinical investigators, members of Steering Committees, clinicians, and scientists in support of innovation and business development.

Requirements:

  • Life sciences degree with a minimum of 4 to 6 years of relevant clinical, preclinical, and/or translational research experience in the pharmaceutical industry or healthcare setting. Advanced degree in life sciences (e.g., PharmD, PhD, MS, MPH) strongly preferred.
  • Educational and/or work experience in one or more of the following is desirable:  microbiology, infectious diseases, allergic diseases, immunology, gastroenterology, oncology.
  • Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
  • Ability to make independent, timely, and appropriate decisions.
  • Ability to work both independently and collaboratively in a fast-paced, team-based matrix environment.
  • Excellent written/verbal communication and presentation skills.
  • High level of organizational and project management skills.
  • Ability to adjust to multiple cross-program demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
  • Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
  • Travel to  internal and external meetings, and scientific conferences (up to 10%).
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