The Senior Vice President, Medical Affairs (SVPMA) will help manage agile, lean and efficient clinical development and medical affairs. The SVPMA will report directly to the Chairman, President and CEO. The primary role of the SVPMA will be to provide medical leadership and direction for Landos’ pipeline of clinical development programs in Inflammatory and Fibrosis areas (Crohn’s disease (CD), ulcerative colitis (UC), eosinophilic esophagitis (EoE), lupus, rheumatoid arthritis, asthma, COPD, NASH, multiple sclerosis, Alzheimer’s disease, type 1 diabetes, psoriasis, and diabetic nephropathy. The SVPMA will be responsible for the strategy, direction and execution of the company’s clinical development plans. He will have direct oversight over the clinical development and medical affairs components of Landos. The SVPMA will be a key member of the Senior Leadership team. The SVPMA will assist Landos in the Phase 1-4 clinical development of BT-11, NX-13 and other clinical therapeutic assets. The SVPMA will drive clinical innovation keeping the corporate goals, vision and corporate culture in mind.
This position will be completely aligned with Landos’ entrepreneurial culture fueled by innovation, efficiency and growth that is encapsulated in four fundamental pillars: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- Provide clinical insight and leadership to ensure that Landos achieves its clinical goals and identifies compelling new opportunities.
- Direct the clinical strategies and plans to integrate Landos’ compounds into the standard practice of inflammatory and fibrosis diseases and supervise the implementation of the tactics.
- Must have and maintain a comprehensive knowledge of the competitive environment for drugs in inflammatory and fibrosis disease market and in R&D pipelines.
- Responsible for generation and dissemination of clinical data. Ensure timely publication planning and communication activities in support of Product Strategy and Life cycle Management Plan.
- Develop interactions with academic thought leaders, investigators, cooperative groups, advocacy groups, key opinion leaders (KOLs) and other clinical stakeholders for positioning Landos as a key player in IBD.
- Responsible for overseeing the activities of the Medical Affairs team: generate and disseminate clinical data, work closely with the CSO, Executive Scientific Director and Associate Director Inflammation and Immunology to develop and execute a scientific communication plan including publication and congresses, supervision of medical information.
- Design the commercial strategy and provide support for corporate development and commercial activities.
- Contribute to, reviews and approve medical/scientific communications including marketing materials and participate in Promotional and Scientific Content Approval Processes.
- Identify training needs in collaboration with key stakeholders and ensure implementation of medical training programs for the field medical team as well as other cross-functional members as appropriate.
- Provide input on strategic planning for new drug development.
- The SVPMA will collaborate with the CMO and EVP of Operations & Regulatory Affairs to supervise clinical activities: contribute significantly to the design of the clinical development plans for Landos. Supervise the design and optimization of Phase 1-4 clinical trials, develop processes and procedures to ensure patient safety, oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results. Timely execution of trials through final medically relevant reports.
- Work closely with the CEO, CMO, CSO and EVP of Operations & Regulatory Affairs in the recruitment and retention of steering committees, Data Monitoring Board and external collaborations.
- The SVPMA will interface with the Clinical Operations and Regulatory Compliance department through the EVP for providing support to the implementation of clinical trials and management of regulatory strategies (global site selection, support site feasibility, investigator meeting support, site initiation visits, motivational/boosting visits (virtually and in person), regular follow up with investigators, support clinical operations and CROs as needed. Review regulatory correspondence and meetings with FDA, EMA and other relevant health authorities. Supervise integrated summaries supporting regulatory submissions.
- Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy.
- Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
- Accountability for financial performance of all activities.
- Oversee the clinical assessment of business development opportunities.
- Faithfully performs any other tasks requested by the Chairman, President and CEO.
- Team-science oriented and data-driven, engendering credibility and confidence within and outside the company.
- Maintain the strictest confidentiality of all the company deliberations and plans.
- Act in accordance with Landos’ policies and in alignment with Landos’ entrepreneurial corporate culture.