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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science, Neuroscience- Pulmonologist / Neurologist in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future
to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES :
The Associate Medical Director leads and drives strategy for the overall global (US / EU / Japan / China) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical / medical decision making to clinical development issues. This individual interacts with and influences R&D and Global Product Launch & Strategy (GPLS) senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.
POSITION ACCOUNTABILITIES :
Leads Global (US / EU / Japan / China) Development Team for a given product. May lead the Development Sub Teams or study teams and represents Clinical Science on the Global (US / EU / Japan) Development Team to ensure that activities are aligned with the global strategy.
Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
Responsible for medical monitoring activities, assessing issues related to protocol conduct and / or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner / acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with GPLS & Business Units.
Interacts directly with Neuroscience Drug Discovery Unit based on pertinent clinical and development expertise and with Business Units to provide knowledge / understanding of market environment in line with status as R&D scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. R&D; USBU; GPLS, JPBU). Lead R&D internal teams and may lead global cross-functional teams, as appropriate.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS :
Pulmonologist / Neurologist with sleep medicine expertise
Skills
Knowledge
Pulmonologist / Neurologist with sleep medicine expertise
This position is currently classified as " hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at
takedajobs.com
No Phone Calls or Recruiters Please.
LI-JV2
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 : Cambridge, MA
U.S. Base Salary Range :
$194,800.00 - $306,130.00
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.
U.S. based employees may be eligible for short-term and / or long-term incentives. 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
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Associate Director Clinical • Cambridge, MA, US