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Career Openings


Sr. Director, Clinical Research

ID: 1573
Department: Clinical Research
Location: Cambridge Headquarters
# of Openings: 1

Description

It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.

The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, the Sr. Director, Clinical Research position will be part of the new Ironwood. The role will remain as described here.

We are seeking a talented, highly motivated and experienced pharmaceutical physician interested in joining our fast-paced company. The primary responsibility of the Senior Medical Director will be to provide medical expertise and leadership necessary to advance the Company’s drug candidates through all phases of clinical development. The Senior Medical Director will drive the design, planning, and implementation of the clinical programs and study protocols for drugs that are in all phases of development and will play a key role in supporting related regulatory activities. This clinical development expert will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs. 

 

Responsibilities:

  • Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy

  • Be the recognized clinical expert for these development program/s both within and external to Ironwood

  • Provide medical input into the design of clinical trials for these development programs

  • Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget

  • Assist in the preparation of clinical protocols and FDA/EMA documents (e.g., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents

  • Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities

  • Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I through to IV safety and efficacy trials; assist in generating the study reports and publications from these trials

  • Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols

  • Collaborate with other members of the Clinical Development and broader R&D teams on medical matters related to drug development

  • Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs

  • Provide clinical, scientific and development expertise to business development initiatives as needed

 

Requirements:

  • An MD or DO degree

  • Medical expertise in internal medicine (specialty training and board certification, or expertise in gastroenterology or cardiovascular disease/hypertension/ [eg., cardiology/nephrology] would be ideal, but is not required)

  • Six or more years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval

  • Possesses thorough understanding of strategic and operational aspects of clinical research and product development

  • Strong general knowledge of regulatory requirements such as apply to clinical drug development, with significant experience interacting directly with Health Authorities

  • Translational medicine expertise a significant plus (not required)

  • Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment

  • Persuasive, effective and flexible in personal interactions at all levels, with strong verbal and written communication skills

  • Strong project management and problem-solving skills

  • Displays sense of urgency, and a willingness to be a “player/coach” able to roll up sleeves to get the work done when necessary


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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a website to which our privacy policy does not apply. You are solely
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