Regulatory Affairs Director jobs in North Dakota

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview

Rhythm is seeking an experienced Medical Director responsible for Germany, Switzerland and Austria (GSA), based in the GSA cluster, with exceptional scientific and medical expertise to join our team. In this role, you will lead and develop an expanding team consisting of 6 Scientific Affairs Managers (SAMs) in Germany and – with a dotted line – 2 Country Operations Leads (COLs) in their medical function in Austria and Switzerland. The primary task of the Medical Director will be to shape scientific, medical, strategic and operational excellence throughout the GSA organization, foster interactions with our centers of excellence and external experts, ensure best in class set-up and implementation of scientific projects, and enhance Rhythm’s reputation as a leading biopharmaceutical company in the field of rare neuroendocrine diseases. Reporting to the General Manager GSA, the Medical Director will collaborate closely with the GSA commercial and International Diagnosis and Medical Affairs teams.

Responsibilities And Duties

• Lead and develop the GSA medical affairs team. The incumbent will have management responsibility for the German SAM team, with a dotted line to the Country Operations Leads Austria and Switzerland in medical affairs matters.
• Leverage synergies and develop individual strengths of all team members to shape a high-performing medical affairs team.
• Foster excellence and establish high standards in scientific and medical competences, value-based customer interaction, and project execution amongst the SAM/COL team. Set up and implement training/coaching measures as needed.
• Develop and execute a highly efficient, integrated Medical Affairs strategy for the GSA cluster in alignment with the GM; ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives.
• Secure generation and dissemination of RWE data within and beyond the GSA
• Collaborate closely with the GM, local Marketing & Sales teams and the International Diagnosis, Medical, Market Access and Legal teams to align on the GSA business plan, leveraging best practices, analytics and KPIs.
• Provide scientific and medical expertise and support and serve as a subject matter expert.
• Foster relationships with leading principal investigators and external experts, and relevant medical societies, thereby representing Rhythm and strengthening its reputation in its therapeutic areas.
• Identify education gaps or unmet needs in the health care provider community and facilitate appropriate discussion to formulate approaches to address the unmet needs through medical, scientific exchange and educational material/campaigns.
• Work closely with internal stakeholders across the product development lifecycle to influence clinical trial study design and identify, inform, and deliver on needs for post-marketing clinical trials and registries.
• Foster ongoing generation of medical insights and competitive intelligence and set up and update respective intelligence databases
• Align with PV and MedInfo team and secure seamless and timely processing of product safety data and customer medical requests.
  
  

Qualifications And Skills

• Degree in Medicine or PhD in Sciences required.
• Preferred 8-10 years’ experience in medical affairs for the biotech and/or pharmaceutical industry.
• 5 years leadership experience preferentially in medical teams.
• Preferred experience in Endocrinology, Genetics, Internal Medicine, or Pediatrics.
• Rare Diseases knowledge is a plus.
• Track record in leading strategic medical projects and best-in-class tactical execution, as well as in customer interaction.
• Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders.
• Excellent communication and presentation skills; fluent in English and ideally a second European language.
• Proven ability to work in a team environment and build solid working relationships within commercial and other functions nationally and internationally.
• Demonstrated in-depth understanding of drug development and local regulations relating to promotional activities.
• Ability to travel as necessary (up to 50%).
  
  

More about Rhythm

Our lead asset, IMCIVREE® (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE® is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.

We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE® to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.