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Sr. Director/Director Clinical Research - GI

Cambridge, Massachusetts

Post Date: 09/20/2017 Job ID: 1080 Job Category: Clinical: Medical Affairs

My pharmaceutical client is seeking a talented, highly motivated and experienced pharmaceutical physician interested in joining a fast-paced company. The primary responsibility of the Senior Director/ 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, III and Post-approval clinical trials. There are two positions and depending on someone’ s therapeutic area experience each person will be assigned a drug candidate. Key areas – Rheumatology, nephrology, GI.

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 driving the clinical development strategy and 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. 

The Sr. Director/Director, Clinical Research will report to a Sr. VP of Pharmaceutical Development.

Job  Responsibilities:
  • Lead the creation of clinical strategies and development plans for assigned programs across development phases, 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 the client
  • 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, including external partners, 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
  • Travel 20% to conferences
  • May or may not have direct reports, group is evolving from recent changes and this will be determined at a later time

Qualifications/ Requirements:
  • MD or DO degree with Board Certification in GI, Neurology, Rheumatology (depending on area of specialty)
  • Medical expertise in internal medicine
  • A minimum of six years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval; for Director, a minimum of three of relevant industry experience
  • 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

Preferred qualifications:
  • Translational medicine expertise a significant plus (not required)
  • Persuasive, effective and flexible in interpersonal interactions at all levels, with strong oral and written communication capabilities
  • 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
  • Strong project management and problem-solving skills
  • Specialty training and board certification, or expertise in rheumatology, nephrology, GI would be ideal
  • Displays sense of urgency, and a willingness to be a “ player/coach” able to roll up sleeves to get the work done when necessary

Rachel Ambroziak
Senior Recruiter

Rachel brings nearly 15 years of experience to The Steely Group, and specializes in Clinical Staffing. She is respected greatly for her tenacity, determination and great attention to detail. Her success in the recruiting industry is based, in part, on her passion for understanding the needs of both clients and candidates, as well as a commitment to providing exceptional customer service.
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