Logo
Atlas Venture

Senior Director, Medical Affairs

Atlas Venture, Waltham, Massachusetts, United States, 02254

Save Job

Company Address:

21 Hickory Drive, Suite 500, Waltham, MA, 02451 About Sionna Therapeutics Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis.

About Sionna Therapeutics Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis. Job Description

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:

Reporting to the VP, Medical Affairs and Patient Advocacy you will be accountable for advancing Sionna’s scientific leadership in Cystic Fibrosis. The individual in role will be a strategic thought partner providing expert scientific guidance and leading the development and execution of the Medical Affairs strategy to support the pipeline and growth of Sionna. Collaborating with Research and Development, Patient Advocacy, New Product Planning and other key functions, you will collaborate across a matrix organization to ensure the creation and execution of the Core Medical Plan (CMP), with a focus on the integrated Medical Affairs Communications and Congress plan and the Medical Affairs Evidence generation plan (including Health Economics and Outcomes Research (HEOR)) that addresses existing and future data gaps and supports reimbursement needs. You will provide input to the vision and direction for the Medical Affairs strategy and demonstrate the ability to pivot as business needs demand in a dynamic organization. You will thrive in this role if you love engaging with internal and external stakeholders to make positive change, are a self-starter, highly collaborative, and care to positively impact people living with Cystic Fibrosis. Responsibilities:

Develop and execute a highly efficient, integrated Medical Affairs Communications and Congress strategy, identifying educational gaps as well as appropriate resources. Develop and implement clear strategic guidance to scientific communication, internal medical affairs training, external medical education. Identify relevant medical meetings and congresses and determine appropriate participation to ensure strong medical and scientific presence. Work in close collaboration with Research and Development, Patient Advocacy, Regulatory, Legal, Commercial, and other cross-functional partners to ensure engagement strategy and scientific educational initiatives are consistently aligned with Sionna strategy and HCP knowledge needs. Represent Sionna externally in scientific presentations, medical conferences, industry groups. Review with scientific integrity external and internal medical communications, maintaining compliance in all activities. Collaborate with future commercial teams (New Product Planning) with therapeutic area and drug-related materials, training, and educational updates. Propose, develop, and execute the Medical Affairs Evidence Generation plan that addresses existing and future data gaps and supports reimbursement needs. Maintain KOL engagement with key stakeholders to bring relevant insights, collaborating with experts and medical organizations. Fully up to date with most recent HTA and Access needs in the US and globally, prepare and eventually partner with an HEOR Lead to develop appropriate plans for addressing identified gaps and ensure Core Value Dossiers and other outputs are provided in a timely manner. Partner with Clinical Development and Operations, including on trial design, recruitment, and endpoints (such as medical input on patient reported outcome measures to pivotal study design, early access initiatives, investigator-initiated research/studies, publications, and medical communications. Remain current on industry trends regarding new therapeutic approaches; serve as a key medical resource internally in developing strategy and prioritizing issues to inform Sionna initiatives. Collaborate with stakeholders to develop early access strategy and plan, accountable for effective execution of early access plan. Qualifications:

MD, PhD or PharmD or equivalent degree required. 12+ years of Medical Affairs or related experience, in the rare disease space, with substantial HQ-based and launch experience. Experience building successful Medical Affairs function in preparation for launch, US and globally. Thorough understanding of the regulatory, legal and compliance environment and the role of Medical Affairs; ability to contribute to regulatory strategies internally and externally. Excellent written and communication skills, with an ability to effectively present complex medical information to diverse audiences. Strong analytical skills, especially regarding understanding and interpreting scientific research and literature are essential. Demonstrated understanding of budget planning and management. Experience leading or co-leading multiple projects with a high degree of efficiency. Ability to effectively develop and maintain influential relationships with key opinion leaders and external partners. Ability to travel domestically and internationally ~25%. Who You Are:

Curious learner, passionate individual focused on patient outcomes and values. Team player willing to roll up sleeves and bring expertise to others as needed, in a spirit of collaboration and advancing scientific understanding, with track record of achieving results and optimizing team performance. Passionate about patients and their families; inspired to make a difference. Visionary; strategic thinker. Ethical, operates with unwavering integrity. Influential and inspiring, internally and externally. Collaborative team builder. Able to influence without direct authority is critical for this role. Solutions-oriented: demonstrates complex problem-solving skills. Execution mindset; hands-on. Forward-thinking and adaptable, agile thinker.

#J-18808-Ljbffr