Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Global Head Clinical Development Hematology and Coagulation .
Key Responsibilities Include :
Provides tactical and strategic medical leadership and guidance to the global clinical development activities supporting new registrations and life cycle management of the company’s therapeutic compounds, ensuring alignment with commercial strategies and compliance with regulatory guidance where relevant.
Partners with cross functional therapeutic area leads from project management, commercial development, global regulatory and global safety to ensure that the overall scientific and medical content of all clinical programs is aligned, sound and supported by high value data driven decision-
strategies and is documented through program specific plans.
Anticipates and addresses future potential Clinical Development needs and opportunities, based on the clinical character of the compound, evolution of the regulatory and commercial competitive environment.
Ensures Clinical Development planning, strategies and related budgets are updated for stage gate evaluations and present, as required, clinical development strategies and overall benefit / risk evaluations, pertaining to the assigned therapeutic area, to senior management review committees.
For new indications, determines the overall risk / benefit assessment through securing cross functional alignment and / or transparent discussion of risks and benefit pertinent to the clinical program and ensures with relevant department heads / delegates that clear plans to investigate, manage and track risk through the clinical program are reflected in the clinical development plan.
Provides senior leadership to develop, attract and retain talent within clinical development and contributes to the overall strategic and operational running of the clinical development function in line with the spirit of the department.
Drives to maintain a culture based on the company’s core values of customer focus, innovation, integrity, collaboration and superior performance.
Develops and maintains relationships with research, including pre-clinical translational research, and early development to facilitate the integration of non-
clinical and translational science findings, experimental medicine outcomes and first-in-man results within overall clinical program planning.
Acts as an internal clinical therapeutic expert developing and maintaining an understanding of key disease states / etiology, treatments, therapeutic trends, competitive agents for the indications and development projects within the assigned therapeutic area.
Establishes the presence and reputation of the company through thought leadership, interactions with KOLs in fundamental issues affecting the therapeutic area.
Develops and sustains strong professional relationships with regulatory authorities and represents the company, as required, at key regulatory review forums e.
g. pre-IND / EMA Scientific Advice; post Phase II, regulatory advisory committee meetings.
Contributes to internal review of new development opportunities through collaboration with strategy and business development to provide medical and development expertise and recommendations to support the evaluation of in-
licensing candidates where relevant.
We seek candidates with the following qualifications :
An MD or equivalent.Board Certified (or non-USA equivalent).
Requires clinical development experience leading a therapeutic area or complex clinical program with a working knowledge of pharmaceutical and regulatory development processes.
Must have a minimum of 10 years of experience acquired in either industry or academic positions; academic positions must have experience in working with industry sponsors.
Requires strong leadership and communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
Must be able to think globally and contemplate multiple aspects and impacts of issues and plan proactively, and must have demonstrated ability to think strategically, create innovative strategies and able to anticipate future trends and consequences.
Must be able to develop direct reports with regards technical skills and leadership competencies; and build and lead effective, well integrated, collaborative teams.
Must be able to work successfully in a matrix organization with multiple disciplines and to build collaborative relationships within the company.
If interested, please email your resume as a Word attachment to us, reference 3483. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.