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Career Openings


Head of Clinical Research, MD

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 Head of 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 to join our fast-paced company as Head of Clinical Research to help advance the Company’s drug candidates through all phases of clinical development at Ironwood. The primary responsibility will be to oversee the Clinical Research team and provide clinical development leadership as well as medical expertise across the different programs focusing primarily on Gastrointestinal Diseases.  The Head of Clinical Research will play a crucial role as member of the Clinical Development leadership team in driving the strategy, design, planning and implementation of the clinical programs, study protocols as well as supporting related global 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, and co-development partnerships.

 

Responsibilities:

  •  Lead the Clinical Research team and oversee the creation of clinical strategies and development plans for assigned programs in all Phases of clinical development to meet the requirements of the different product development strategies

  •  Be the recognized clinical expert for the different development programs both within and external to Ironwood

  •  Provide medical input across multiple development programs in the design of clinical trials

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

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

  •  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 budgets

  •  Play a key role in the development of analysis plans; the review, interpretation and communication of clinical trial data from across all phases of drug development; and assisting in generating the related study reports and publications

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

  •  Collaborate with other members within Clinical Development, as well the broader R&D organization, including commercial and business development colleagues, in providing clinical, scientific and medical expertise related to drug development

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

 

 

Requirements:

  •  An MD or MD/PhD degree

  •  Medical expertise in internal medicine (specialty training or expertise in gastroenterology or cardiovascular/metabolic diseases would be ideal, but is not required)

  •  Six or more years of pharmaceutical/biotech-industry drug development experience, 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 applicable to clinical drug development, with significant experience interacting directly with Health Authorities

  •  Translational medicine expertise a significant plus (not required)

  •  Managerial experience in leading and mentoring clinical research colleagues as well as working 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

  •  Displays a sense of urgency, and willingness to be a “player/coach” with a ‘can-do’ attitude, able and willing to roll up sleeves to get the work done when necessary

  •  Persuasive, effective, influential and flexible in personal interactions with internal and external stakeholders at all levels, possessing strong verbal and written communication skills.

  •  A strategic, tactical thinker and leader with broad clinical development expertise


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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