Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. Working at Rhythm means that you are part of a team thats passionate about transforming the lives of people living with rare genetic disorders of obesity. 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.
will provide broad based legal support relating to Rhythms lead compound, setmelanotide as well as provide legal support on issues relating to Rhythms development programs/pipelines generally. The attorney will become Rhythms second in-house counsel and will report to the SVP & General Counsel.
Responsibilities and Duties
- Provide advice and counsel to clients on FDA regulations, the Anti-Kickback Statue, False Claims Act, and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, and communications with FDA.
- Advise internal clients with respect to projects, initiatives, and communications regarding approved products and indications as well as those pending FDA approval.
- Support internal clients on research and clinical development programs and activities.
- Review and provide guidance on promotional materials through Rhythms Promotional Review Committee.
- Draft, review, and negotiate research-related contracts, clinical trial agreements, commercial contracts, 3rd party vendor agreements, service agreements, consulting agreements and other corporate agreements.
- Support implementation of compliance program, including policy and procedure development and training.
- Proactively identify legal risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals.
Qualifications and Skills
- JD from accredited law school and license to practice in at least one US jurisdiction.
- 6-8+ years experience as a practicing attorney, with at least 3-5 years experience in the pharmaceutical/biotech industry.
- Legal experience in fraud and abuse counseling, privacy, and FDA issues, with an understanding of the OIGs Guidance for the Pharmaceutical Industry, applicable regulations and laws relating to the development, sales and marketing of pharmaceutical products, and the current federal and state enforcement landscape.
- Experience with drafting, reviewing, and negotiating the types of contracts relevant to the pharmaceutical/biotech industry (e.g., research, clinical, commercial, etc.).
- The preferred candidate will have worked at a leading U.S. national law firm and/or had an in-house counsel position with a leading biotech / pharmaceutical company with marketed products.
- Experience with EU and international laws and regulations governing pharmaceutical/biotech products a plus.
- Working knowledge/experience with GxP a plus.
- Knowledge of the laws and regulations affecting the pharmaceutical/biotech industry, including the Food Drug and Cosmetic Act, Anti-Kickback Statute, False Claims Act, Health Insurance Portability and Accountability Act, and the like.
- Excellent interpersonal communication and negotiation skills, including both oral and written communication skills.
- Ability to independently manage workload in a fast-paced environment. Ability to provide practical, timely, and risk-appropriate legal counsel to a wide variety of internal clients on legal and regulatory matters and interact effectively with employees at all levels of the organization.
More about Rhythm
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. This is a key biological pathway that regulates weight and hunger. A central element of Rhythms mission is to improve the understanding of these disorders and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The companys clinical development program is currently focused on several rare genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, please visit www.UNcommonObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.