We are seeking a talented, highly motivated and experienced pharmaceutical physician interested in joining our fast-paced company. The primary responsibility of the Director of Clinical Research will be to provide medical expertise and leadership necessary to advance one or more of the Company’s lead drug candidates through Phase I, II and III clinical trials. Reporting to the SVP of Clinical Affairs, the Senior Director/ Director, Clinical Research, will drive the design, planning, and implementation of clinical program/s and study protocols for drugs that are in all phases of development, and will play a key role in supporting related regulatory activities.
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 (eg., 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 to III 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 Affairs 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 oral and written communication capabilities
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
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