Vice President, Regulatory Affairs & Global Patient Safety
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Vice President, Regulatory Affairs & Global Patient Safety
We are looking for people to join the Ironwood team who are committed and focused on creating medicines for patients with GI diseases. We have three innovative assets, including our in-market product, LINZESS® (linaclotide) which was discovered in-house and is the branded prescription market leader in its class.
Ironwood is more than just a company; you will join a group of people who come together with their unique perspectives and talents to create medicines that can improve the lives of patients. You will join a supportive, collaborative group of people who challenge each other to think differently, and to find creative approaches to helping patients. You will join a welcoming environment where equality, diversity, and inclusion are integral to who we are and the values we hold as a company. You will join a company where not only what you do is important but also how you do it is equally as important. We challenge each other respectfully because everyone’s opinion matters and we believe that the unique attributes and viewpoints of each team member facilitates the development of innovative ideas that can help us to discover and deliver breakthrough therapies for patients.
If you want to help us build the next great pharmaceutical company please apply!
Over the past several years Ironwood has experienced sustained, rapid growth, which is projected to continue in the foreseeable future. The Regulatory and Safety leaders have played a critical role in Ironwood’s success. As the company transitions to a focused development and commercialization company with a strong pipeline, it has been deemed necessary to recruit a seasoned Head of Regulatory Affairs & Global Patient Safety. This person will play an active, critical role in developing and executing the overall global regulatory affairs and patient safety strategies as the company continues to advance its pipeline and commercialize new and novel drugs. You will also work with a Head of GPS to establish a global vision and influence the drug safety mindset in support of our company mission and long-term objectives in creation of a leading edge, innovative team. Such an individual is the object of this search.
The Head of RA & GPS will report to Head of Global Development/Chief Medical Officer and will lead Ironwood’s regulatory and GPS departments to support the development, registration, and life‐cycle management of the company’s products. The Head of Regulatory Affairs & Safety will ensure all needs of the organization are resourced with appropriate regulatory and safety expertise to successfully implement regulatory and safety strategies as well as business objectives. S/he will also lead development and implementation of department policies as well as maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. S/he will continue work well together with external global partners and other internal departments; we are looking for a like‐minded leader who values a collegial work environment and evidence-based strategies.
In addition to leadership of the Global Regulatory Group, this position will lead Drug Safety and Pharmacovigilance. Therefore, this leader will establish a global vision and influence the drug safety mindset in support of Ironwood’s mission and long-term objectives by evolving the GPS/PV team into a leading‐edge function. With innovative leadership s/he will utilize data to shape the direction of future product development in a complex and rapidly changing business environment.
The Head of Regulatory Affairs and GPS will play a major role in ensuring collaboration and strong relationships both internally with various departments, and externally with regulatory agencies, business partners and vendors. In this role, you will drive the values that comprise our company culture, be the champion for our commitment and efforts to proactively ensure the management and appropriate communication of benefit-risk of our compounds.
At a personal level, we are seeking an individual who is intelligent, trustworthy, dedicated and operates with strong independent judgement. The Head of RA and GPS must be decisive, self‐motivated and highly communicative as s/he will work collaboratively and effectively not only within the regulatory and safety organization but across other disciplines to achieve shared objectives. This individual will also have strong strategic skills, including a demonstrated ability to make complex decisions and a willingness to defend difficult positions and demonstrates the ability to collaborate with internal and external partners. S/he must be a strong leader who possesses a proven track record in leading an organization through change and rapid growth and ensuring the appropriate capabilities are in place to support such growth.
While it is critical that this individual fully integrate into Ironwood’s culture of excellence, it is expected that this person will also be able to thoughtfully challenge the status quo, but at that same time backup his/her ideas with sound, rational data. Furthermore, it is important that this person bring an entrepreneurial style to fit into the company’s relatively flat, non‐hierarchical culture. Effective management, negotiation, and problem-solving skills are necessary. It is also paramount that the Head of Regulatory Affairs & Global Patient Safety have unquestionable integrity and the highest ethical standards. Finally, it is expected that this individual share in the company’s patient‐centric mission and deep commitment to discovering and developing exceptional medicines for patients.
Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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