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Senior Manager/Associate Director - Field Medical Science Lead, U.S.

Cambridge, MA

Title:                   Sr. Manager/Associate Director – Field Medical Science Lead, U.S.

Location:           United States

Reports to:        VP, Head of Medical Affairs

 

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 Phase 3-ready candidate 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:

The Field Medical Science Lead – U.S. will report to the VP, Head of Medical Affairs.  The successful candidate is an experienced field-based scientific and clinical professional who will support the medical affairs and therapeutic development objectives of Vedanta’s late-stage and in-line portfolio (C. diff and UC) in the assigned geographic territory(ies). The position will have the responsibility for the planning, implementation, and daily operation of assigned projects in Medical Affairs in the covered regions. The individual will conduct compliant scientific engagements and will communicate medical information to Healthcare Practitioners (HCPs), such as study investigators and key opinion leaders (KOLs), and will identify and facilitate collaboration opportunities. Furthermore, this position requires effective communications and collaborations with key internal and external stakeholders to support company initiatives that improve the quality and content of all relevant medical and clinical research programs.

Here’s What You’ll Do:

  • Support the development and implementation of the medical affairs priorities, objectives, and plan, tailored to the needs and situation of the assigned territory, in line with the region's medical plan and scientific engagement plan, to support best practices and company therapeutic development objectives
  • Conduct scientific exchanges with relevant disease-specific HCPs and KOLs, to understand scientific areas of interest and medical unmet needs
  • Provide evidence-based and fair balanced scientific information about Vedanta’s current and future clinical programs, current and future research activities, and early access programs
  • Manage and address timely and appropriately all unsolicited requests about relevant approved and investigational therapies based on the available scientific data, utilizing approved global medical information resources developed per US FDA regulatory requirements
  • Provide high-quality medical education presentations at peer-to-peer or other meetings, such as roundtables, hospital meetings, and staff meetings, and obtain and communicate relevant feedback
  • Regularly review relevant literature, participate in scientific congresses and conferences including internal therapeutic area training sessions to maintain current knowledge, and gather competitive insights on other relevant therapies
  • Support regional and national symposia and other medical education events as needed
  • Support regional and national market access initiatives in a compliant way
  • Play a role in internal training and communication within Medical Affairs and with other functions as needed
  • Support medical affairs initiatives in understanding feasibility of new indications, patient pathways, diagnostic practice, the healthcare environment, and strategies in relevant disease areas
  • Assist the medical affairs team in the identification of potential clinical trial investigators in the assigned region and countries and other research projects, such as investigator-sponsored trials (ISTs), study site identification, recruitment and enrollment strategies, and collaboration with clinical operations
  • Maintain a high level of knowledge of and appropriately implement current US pharmaceutical regulations and best practices, and Vedanta’s policies and procedures
  • Ensure a compliant cross-functional working relationship with other externally facing functions as appropriate

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, the expectation is for the individual to perform all other duties as assigned or required, as training and experience permit. This role is an external stakeholder-facing and in-field role. You should plan to spend 60-70% of your time devoted to in-field and/or related HCP engagements.

Requirements:

  • Master and/or Doctorate-level degrees in the health sciences
  • Minimum 3-5 years of field-based Medical Affairs experience in Biotech or Pharma
  • Experience in infectious diseases, gastroenterology, immunology and allergy, and/or immune-mediated diseases is a plus
  • Excellent interpersonal communication and presentation skills, including the ability to network
  • Able to participate in impactful scientific exchange with KOLs and researchers
  • Demonstrated ability and entrepreneurial spirit to organize, prioritize, and work effectively with minimal supervision in a constantly changing environment
  • Excellent teaching skills and ability to present and discuss scientific material clearly and concisely
  • Able to function in a highly regulated environment and to adhere to all company/corporate guidelines and standard operating procedures (SOPs), while responding to a variety of questions and requests from healthcare professionals
  • Ability to work independently and to converse on a peer-to-peer basis with HCPs
  • Thorough knowledge of the US healthcare system, disease management, and medical research
  • Current working knowledge of legal, regulatory, and compliance regulations, and guidelines relevant to industry interactions with HCPs
  • Proficiency in MS Office (Word, PowerPoint, Excel), Teams, Outlook, and CRM platforms
  • Fluent in English verbal and written communication skills

Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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