Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system. Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies.

Tasks

The VP of Clinical Development Women's Health, reporting to the Chief Medical Officer, will oversee clinical research, medical management, and study execution for one or more of the Company’s clinical programs and is a key member of the Research and Development Leadership Team. In line with the Company’s 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 Company’s 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 Women’s Health and/or with clinical or clinical development experience in Women’s 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 Women's 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

Candidates needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. This is a hybrid position with 3 days working on-site in Basel.