VP, Head of Medical Affairs
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide-binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co-founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.
Position Summary:
The Vice President (VP) and Head of Medical Affairs is a critical hands-on leadership role as Sionna grows and evolves, establishing and overseeing Sionna’s Medical Affairs strategy and function across all programs. Reporting directly to the Chief Medical Officer, the VP will focus on creating and managing the Medical Affairs infrastructure, supporting scientific communications, collaborating with clinical development, and liaising with commercial functions. This individual will build and lead a high-performing team that will directly contribute to clinical and scientific excellence and play a major role in Sionna’s future success. We are seeking a motivated, experienced, patient-centric VP to lead this function who will thrive in Sionna’s fast-paced, dynamic, highly collaborative environment.
Responsibilities:
- Lead the development and execution of Sionna’s Medical Affairs strategy, ensuring alignment with company goals and priorities.
- Build and manage a high-functioning, stage-appropriate global Medical Affairs organization to include publications and scientific communication support, Medical Science Liaisons (MSLs), medical/scientific exchange, evidence generation and other appropriate functions.
- Oversee all aspects of Medical Affairs operational and tactical plans, budgets, and processes and ensure compliance with regulatory requirements and industry standards.
- Collaborate with clinical development, regulatory affairs, and leadership to support clinical trial execution, including building relationships with key external stakeholders.
- Lead strategy and support for scientific and clinical publications, and Congress and related presentations.
- Liaise with commercial functions to support strategic plans and infrastructure, and with investor relations to address scientific and medical information needs.
- Collaborate with clinical development and Patient Advocacy on engagements with professional societies and patient/external advocacy.
- Monitor and analyze emerging clinical and research trends in cystic fibrosis to inform strategic decision-making.
- Provide Medical Affairs input for consideration for future business opportunities.
Qualifications:
- 12-15 years of pharmaceutical/biotechnology industry Medical Affairs experience in the US and globally.
- MD degree or equivalent; specialized expertise in pulmonary, allergy/immunology gastroenterology, or other relevant fields is a plus.
- Medical Affairs and/or Clinical Development experience in cystic fibrosis, pulmonary disease, and/or rare disease highly desired but not required.
- Experience building and leading Medical Affairs teams, with experience in growing organizations preferred.
- Strong understanding of global drug development and compliance environment, including regulatory processes and guidelines, payor dynamics, early access and related programs, and commercial strategy.
- Experience leading and executing advisory boards.
- Experience interacting with thought leaders, academic centers, and professional organizations, and with regulatory and HTA authorities.
- Strong publication strategy and scientific communication background; deep familiarity with ACCME and other relevant guidelines.
- Ability to master complex clinical and scientific material and to translate for appropriate, compliant external and internal use.
- Ability to travel to the Waltham, MA office for selected in-person meetings with necessary; willingness to travel approximately 20-30%, including international travel for conferences, meetings, and advisory boards.
