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Associate/Medical Director

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

The Associate/Medical Director will be responsible for providing clinical leadership of clinical development programs, and for the design, execution, and analysis of clinical trials, as well as for supporting Medical Monitoring activities across trials. This role reports to the Vice President of Clinical Research and will collaborate with other functional members in the organization.

The Associate/Medical Director has proven leadership skills and the ability to successfully guide and influence cross-functional teams. The individual collaborates with internal stakeholders such as Clinical Operations, Regulatory Affairs, Translational Medicine, Clinical Pharmacology, Data Management as well as with external collaborators such as study investigators and their staff, Key Opinion Leaders, CROs and vendors.

Here’s What You’ll Do:

  • Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
  • Develop global clinical strategies working in collaboration with internal and external colleagues to fulfill the corporate goals and objectives; oversee the product development strategy, clinical development plan.
  • Lead the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
  • Direct, design, author, and review clinical trial protocols, protocol amendments, informed consent documents, investigator brochures, CRFs, monitoring plans, data and statistical analysis plans, etc.
  • Author and review sections of clinical study reports and regulatory submission documents, such as, INDs, CTAs, BLAs, regulatory agency briefing packages, etc.
  • Lead the review, analysis, and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
  • Be responsible for the scientific execution as required for the initiation, conduct, and medical monitoring of Phase 1-3 clinical trials
  • Prepare, present, and defend complex aspects of protocol design and/or medical study data at internal meetings or investigator meetings
  • Actively engage in the planning, preparation, and participation of regulatory meetings, e.g., Pre-IND, End-of-Phase 2 meeting, or other regulatory meetings
  • Prepare and/or review clinical sections of required regulatory documents, including briefing documents, Investigational New Drug (IND) filings, Clinical Trial Applications, safety reports, final study reports, and Biologic License Application (BLA) filings.
  • Collaborate with external stakeholders such as study investigators and their staff, Key Opinion Leaders, CROs, and vendors during all phases of the clinical trial and program.
  • Prepare and review draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators
  • Provide ongoing overview of plans, and update plans as project needs change, keeping stakeholders and contributors aligned with changes both in the external environment and across Vedanta Biosciences

Requirements:

  • MD degree with a minimum of 1-3 years of pharmaceutical/biotech industry experience.
  • Ability to develop and conduct complex clinical research programs independently.
  • Proven leadership skills and ability to successfully guide and influence cross-functional teams.
  • Ability to develop, author, and review Clinical trial protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, Safety Monitoring Plans, Development Safety Update Reports, and other regulatory documents
  • Robust experience in the review, analysis, and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
  • Ability to evaluate safety events (e.g. SUSARs, laboratory observation, etc.) and analyze in conjunction with similar events across clinical trials and programs. Will be able to closely collaborate with the Safety and Pharmacovigilance group and Medical Monitors at the CRO.
  • Experience in one or more of the following clinical areas is desirable but not a must: Infectious diseases, gastroenterology, immunology, oncology. Prior medical practice and board certification is a definite plus.
  • Deep understanding of Good Clinical Practices (GCPs) is necessary. Has successfully conducted clinical trials in a GCP/ICH compliant environment
  • Demonstrated ability to analyze, interpret, and present complex scientific clinical data to both subject matter (e.g. Key Opinion Leaders) and non-subject matter experts, and to draw medical and scientific conclusions
  • Demonstrated solid understanding of biostatistics, trial planning, and sample size generation in collaboration with the biometrics group
  • Basic understanding of clinical pharmacology and microbiology
  • Experience working directly with Clinical investigators and ability to provide leadership in protocol-related discussions (e.g. entry criteria of the protocol) with representatives of clinical operations, investigators, and investigator trial staff
  • Demonstrated scientific expertise in the presentation and publication process with a track record of publishing peer-reviewed scientific data, e.g., posters, oral presentations, review articles, and manuscripts
  • Ability to work well in a cross-functional team environment which includes representatives of Biometrics, Clinical Operations, Regulatory, Safety, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, etc.
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