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CAREER OPENINGS


Vice President, Regulatory Affairs & Global Patient Safety

ID: 1643
Department: Regulatory Affairs
Location: Cambridge Headquarters
# of Openings: 1

Description

Vice President, Regulatory Affairs & Global Patient Safety

Functional area: R&D / Regulatory Affairs & Global Patient Safety (GPS)

Position description:

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. 

 

Responsibilities:

  • Oversee

    • the development and execution of global regulatory strategies in support of project objectives for Ironwood’s products;

    • planning and execution of meetings with health authorities;

    • regulatory due diligence assessments of new product

    • regulatory review of external facing communications, including corporate communications, and investor relations;

    • Keeping abreast of changes in the regulatory environment and adapting strategies appropriately;

    • Development of timelines and budgets for department activities;

    • Preparation and submission of global regulatory filings.

  • Providing review and commentary on regulatory documents;

  • Collaborates and ensures alignment with internal functions and external partners

  • Directing and mentoring regulatory staff;

  • Accountable for providing medical and scientific expertise regarding the safety and risk assessment of the product portfolio at all stages of the product lifecycle and for the establishment of the strategic global plans and policies, inclusive of facilitating effective PV collaboration with alliance partners globally;

  • Ensuring professional development of staff;

  • Overseeing the development and execution of safety (benefit-risk) strategies in support of project objectives for Ironwood’s products

  • Providing appropriate resources (internal and or external) to ensure that the functions can support the company’s goals;

  • Overseeing the development of systems and procedures necessary to maximize the efficiency of the regulatory affairs & safety departments, and to comply with regulatory requirements;

  • Contribute to creating and communicating an employment culture and values which attracts, retains and develops the team at all levels in order to maximize their potential contributions to the function and business. 

Basic qualifications:

  • Advanced degree (M.S., Ph.D., Pharm.D., M.D.). It is understood, however, that education, while important as an indicator of character, intellectual ability and achievement, will be subordinate to personal qualities and professional accomplishments as variables in the selection process. 

  • An individual who possesses a minimum of 15 years of relevant experience (e.g. biotechnology, pharmaceutical industry, regulatory agency), with a minimum of 5 years in a senior leadership role managing a global regulatory function.

  • A broad experience across therapeutic areas, especially gastroenterology and significant experience in collaborations with partners. Furthermore, s/he must have experience in global regulatory filings, especially in the US, lifecycle management, leading interactions with Health Authorities, and developing and implementing complex regulatory strategies.

  • Experience in submitting at least two marketing authorizations and oversight of multiple commercial products.

  • Previous leadership of, or close collaboration with, a development and commercial Safety organization

  • Proven track record in creating and sustaining a leading‐edge, high quality global Pharmacovigilance team operating within the complex global regulatory-pharmacovigilance environment.

  • Demonstrated success in leading, managing and developing team members

  • Proven track record of successful management of product safety matters (product recall, regulatory inspection, etc.)

  • Demonstrated experience in the preparation of global risk management plans, aggregate reports and Company core safety information

 
Preferred qualifications:

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.

 

 

 


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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