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Job Description

About the role:

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.

How you will contribute:

+ You will 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. This includes working with regulatory, PV, clinical operations, clinical pharmacology and CMC. 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 oversees the preparation / approval of study synopses, protocols and the conduct of clinical studies. Make expert recommendations on scope, complexity, size and budget.

+ Is responsible for the successful design and interpretation of clinical studies and present study conclusions to the leadership team with determination on how study results impact the overall compound strategy.

+ 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 that is competitive and consistent with the latest environmental requirements, proactive identification of challenges, and development of contingency plans to meet them

+ Set the strategic publications directions for related research in partnership with the Medical Unit and Therapeutic Area. Author/supports publication and presentation of data generated through US Medical Research.

+ Review and assess overall safety information together with Pharmacovigilance and assigned Medical Director.

+ Collaboratively works with scientists from alliance partners.

+ Provide clinical development expertise across US Medical.

+ Active member of various Takeda committees and task forces which determine the processes for developing and implementing Global Takeda standards that are used in clinical development, post-marketing surveillance, and Pharmacovigilance process to promote the consistency of data throughout the Takeda group companies.

What you bring to Takeda:

+ You will have a 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.

Skills

+ Superior communication, strategic, interpersonal and negotiating skills

+ Ability to predict issues and solve problems

+ Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams

+ Diplomacy and positive influencing abilities

Knowledge

+ GCP/ICH

LICENSES/CERTIFICATIONS:

+ Licensed health care provider a plus but not required (MD, PharmD/RPh, PA, NP)

Travel requirements:

+ Ability to drive to or fly to various meetings.

+ Overnight travel may be required (10-30%), including some weekend commitments.

+ Limited international travel may be required.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Exton, PA

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._

Locations

Exton, PA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes