Responsibilities will include, but are not limited to, the following:
- Provide therapy area medical and scientific expertise to study teams and key stakeholders.
- Lead the development of the clinical strategic plan for product/therapy area. Identify what is needed to drive the product/therapy area and the specific operational plan to get there.
- Ensure that the strategic positioning is in line with company goals and anticipate and plan for problems/challenges and establish contingency plans and course corrections.
- Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.
- Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
- Oversee quality, coordination and timeless of clinical sections of IND’s, Investigator Brochures, CTA’s , ISS’, ISE’s and clinical expert reports.
- Represent the team with internal and external leaders and instill confidence in stakeholders by possessing a broad knowledge of the pharmaceutical industry and business environment and their impact on the product/therapy area.
- Work with Therapeutic Area Head and other team members to prepare abstract, manuscripts and presentation for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Lead the development of a significant clinical development budget and effectively manage resources, funding and expenses.
- Cultivate and nurture strong collaborations, relationships and support with Investigators, Academic partners and KOL’s.
- Collaborate extensively with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input.
- Serve as a global lead for one or more functions such as: Clinical Science, Clinical Quality, Disease Area, Product Champion, Region CRD Development and Business Development.
- The ability to establish, communicate and drive a vision and strategy for the therapy area/product and develop and integrated plan of action including milestones and endpoints and ensure executional excellence.
- Viewed as a global leader with the therapeutic area/disease state and considered a scientific contributor and innovator within internal and external spheres of influence.
- The ability to think globally, strategically and innovatively about the future of the disease state and company’s therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain.
- Attract and develop talent, coach and mentor others to higher levels of performance. Create an atmosphere of innovation and continual improvement.

Skills/Knowledge Required:
- Create complex strategies to develop the franchise or product and successfully articulate this to various constituents such as governance committees, project teams, clinical sub-teams, and other senior management to build enthusiasm, passion and commitment.
- Build teams by understanding the skills and capabilities needed to effectively meet goals and objections and align them with the talents and capabilities of team members.
- Reinforce open-mindedness, diversity of thought, collaboration, best practice sharing and risk taking among team members and stakeholder groups.
- Champion employee development training.
- Make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.
- Optimize extensive knowledge of the clinical development process and strong relationships with team members, colleagues and internal and external stakeholders to achieve results.
- Foster innovation and informed risk taking among staff members and study team colleagues.
- Act as an agent for change when new projects are launched or priorities change by creating and communicating value proposition or business rationale.
- Present opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one’s convictions and commitment.
- Handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies.
- Garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.

Qualifications
- Minimum M.D. degree and substantial medical/clinical training in Hematology/Oncology
- Minimum 5 years of experience designing, leading and managing significant clinical trials in Hematology/Oncology Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.