
Clinical Science Director, Clinical Research, Value and Evidence Generation
Exton, PennsylvaniaAt Takeda, it's our people, our values and our culture that make us special. We share a sense of vocation and a desire to serve others that pulses through our entire organization. We're fortunate to be grounded in a history that gives us a long term perspective, the confidence to stick to what we believe in, and the humility to know we don't have all the answers.
We combine this outlook with an agility and tenacity to deliver for our patients that has fueled the growth of our business. But what really sets our company apart is something we call Patient Trust Reputation Business. It's the framework that enables us to translate our purpose and values into action. It's how we synchronize the diversity of our perspectives, strengths and expertise. And it’s what keeps our decision making tethered to what really matters.
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Job Description
About the role:
Join Takeda as a Clinical Science Director, Clinical Research, Value and Evidence Generation where you willbe 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, PAU.S. Base Salary Range:
$174,500.00 - $274,230.00The 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.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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, PAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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