Clinical Science Director, Clinical Research, Value and Evidence Generation

About the position Join Takeda as a Clinical Science Director, Clinical Research, Value and Evidence Generation where you will be responsible for strategic input, leadership and scientific direction for US Medical research plans across all therapeutic areas. You will also direct a multi-disciplinary matrix team through complex decisions. You will develop clinical research protocols across all therapeutic areas, decisions assessing and integrating the input from various disciplines to create a comprehensive research plan to result in completion of the studies and includes a clear strategic publication plan. As part of the US MA team, you will report to the Sr. Director & Head, US Medical Clinical Science, Clinical Research & Research Process Excellence. This is a hybrid position based in Exton, PA.

Responsibilities

• Work with medical leads to determine the clinical gap and develop the strategy for the product.
• Provide clinical expertise and interact with internal and external research collaborators to ensure proper and successful implementation of the studies.
• Provide strategic leadership and scientific direction for research plans across therapeutic areas.
• Interact with R D, GMA and other internal partners to ensure agreement on company and product strategies.
• Lead internal multidisciplinary teams to drive critical research program decisions.
• Lead meetings and negotiations with key external investigators and incorporate their advice and recommendations into the design of clinical studies and programs.
• Create a full research plan and oversee the preparation / approval of study synopses, protocols and the conduct of clinical studies.
• Make expert recommendations on scope, complexity, size and budget.
• Responsible for the successful design and interpretation of clinical studies and present study conclusions to the leadership team.
• Partner and work with the US Medical Clinical Research and Process Excellence Team to provide oversight and ensure execution of research plans.
• Provide ongoing critical evaluation of the research strategy to maintain a state-of-the-art research plan.
• Set the strategic publications directions for related research in partnership with the Medical Unit and Therapeutic Area.
• Author/support publication and presentation of data generated through US Medical Research.
• Review and assess overall safety information together with Pharmacovigilance and assigned Medical Director.
• Collaboratively work with scientists from alliance partners.
• Provide clinical development expertise across US Medical.
• Active member of various Takeda committees and task forces.

Requirements

• Doctoral degree in a health science related field such as PharmD, PhD or MD.
• MD candidates will have 8 years of clinical research experience in the pharmaceutical industry.
• A PhD or PharmD will have 10 years of clinical research experience in the pharmaceutical industry.
• Previous experience successfully leading a clinical research team with responsibility for multiple studies and therapeutic areas preferred.
• Candidates with a Master's degree in a health science-related field and extensive clinical research experience within the pharmaceutical industry (12+ years) will also be considered.

Nice-to-haves

• Superior communication, strategic, interpersonal and negotiating skills.
• Ability to predict issues and solve problems.
• Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.
• Knowledge of GCP/ICH.

Benefits

• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• Accrual of up to 120 hours of paid vacation for new hires.

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