US: Clinical Research Physician (Senior)

Date: 18-Sep-2014
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/

Clinical Research Physician (Senior)

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;

• 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 eligibility in gastroenterology or cardiology 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;

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/