Contract – Clinical Research Scientist

Title:                   Contract - Senior/Clinical Research Scientist

Location:           Cambridge, MA

Reports to:        Senior Vice President, Clinical Research

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a in a Phase 3 trial for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

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.
• 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 meetings, external meetings, and scientific conferences (up to 10%).