(Senior) VP Clinical Sciences VMS Women's Health

Noema is developing a late-stage portfolio of oral small molecule therapeutics with well-characterized mechanisms and distinct features that offer unique therapeutic advantages for neurological and other disorders. The Company is advancing three programs in parallel across orphan and large-market indications targeting therapeutic areas of high unmet need and limited competitioneach with blockbuster potential.

Tasks

The (Senior) VP Clinical Sciences VMS / Womens Health reporting to the Chief Medical Officer will oversee clinical research medical management and study execution for one or more of the Companys clinical programs and is a key member of the Research and Development Leadership line with the Companys growth the candidate will significantly contribute to the development of the current pipeline and future therapeutics.

Domains of responsibilities below executed in a dynamic environment to contribute to the strategic vision for the future of the company.

• Medical Stewardship/Clinical Leadership: Provide medical and scientific expertise on the strategy execution interpretation and reporting of data; oversee all clinical development activities for assigned projects
• Scientific communication: Develop internal and external communication approaches regarding medical matters serving as a medical spokesperson as appropriate
• Relationship Building: Establish and maintain relationships with key opinion leaders in the field and incorporate feedback into clinical strategies
• Regulatory Activities: In collaboration with functional leaders medical writing and head of Regulatory Affairs review interpret and prepare medical sections of regulatory documents
• Operational Leadership: Provide leadership including clear communication of objectives the development of key strategies and tactics and oversight of team performance on a regular basis in collaboration with Program and Operational R&D colleagues

Tactical methods/deliverables related to responsibilities:

• Has overall responsibility for the clinical and scientific oversight of clinical studies ensuring study integrity execution data generation and communication as it pertains to the safety and efficacy of the assigned compound(s) and program(s)
• Participates as an active key member of the R&D Leadership Team and is a member of the Companys Scientific community
• Provides medical and strategic leadership for the development of clinical research strategies aligning with company objectives and regulatory requirements and is the Company scientific and medical expert on the program and disease state.
• Designs and manages the execution of human research for therapeutic candidate molecules by leading and overseeing the planning execution and interpretation of one or more clinical studies (may be Phase I to Phase III)
• Responsible for the design analysis and interpretation of clinical protocols.
• Analyzes and interprets results to guide scientific direction clinical studies and pipeline prioritization
• Drives internal efforts by co-managing a variety of relevant CROs as well as an internal team to meet clinical milestones
• Oversees the medical monitoring of ongoing studies ensuring the safety of participants and the accuracy of data collection.
• Integrates the science and the financial strategy through managing the budget and timeline commitments for development compoundsContributes to regulatory submissions and interactions including participation in meetings with health authorities and review and interpretation of data for safety reports IBs NDA submission and responses to questions from regulatory agencies
• Builds and maintains relationships with key stakeholders internal and external including senior management cross-functional leaders academic and industry leaders and other external stakeholders (access patient advocacy) to establish trust increase value and partner effectively with the community
• Actively maintains industry awareness to continue to encourage innovation by knowing key competitor data and the emerging competitive landscapePresents effectively across different audiences (e.g. lay academic) at conferences and scientific meetings

Requirements

• MD board eligible/board certified in Internal Medicine or Womens Health and/or with clinical or clinical development experience in Womens Health
• At least 10 years of academic and Pharma/Biotech experience with a strong record of product clinical development experience in Internal Medicine and/or in Womens Health
• Able to lead matrix teams through inspirational as well as hands-on leadership
• Experience as spokesperson to external stakeholders with a focus on academic thought leaders in Womens Health
• Excellent planning and strong organizational skills able to manage multiple tasks simultaneously and set priorities
• Excellent conceptual science thinking
• Self-motivation and able to work independently in a fast-paced small company environment hands-on in a very small team with limited internal resources
• Pro-active and problem-solving attitude
• Deep and recognized commitment to making a difference in the lives of patients

If you live in the Boston area and if your profile matches the above description we look forward to your application.