Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit
Company: Takeda Pharmaceutical
Location: Reading
Posted on: May 13, 2022
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Job Description:
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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/ Medical Director, Clinical Science in
our NS Therapeutic Area Unit in our Cambridge, MA or Zurich
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 / Medical Director leads and drives
strategy for the overall global clinical development of assigned
Takeda pipeline compound(s) taking into consideration the medical,
scientific, regulatory and commercial issues. Leads
multi-disciplinary, multi-regional, matrix team(s) through highly
complex decisions. This individual has the responsibility for
development decisions assessing and integrating the input from
various disciplines to create, maintain, and execute a clinical
development plan that will result in the regulatory approval of the
compound in multiple regions. Applies clinical/medical decision
making to clinical development issues. This individual interacts
with and influences R&D senior leadership decision-making 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.
ACCOUNTABILITIES:
Clinical team leadership and Project Team / Clinical team
membership
Leads clinical teams as Global Clinical Lead or represents Clinical
Science on Project and Clinical teams Supports the Global Project
Team to ensure that the clinical team activities are aligned with
the global strategy. Contributes to the overall Asset Strategy by
leading generation of the Clinical Development Plan, Clinical
Protocols and other documents needed for CDP and study execution
and regulatory submissions. Recommends scope, complexity and size,
and influences the budget of all aspects of a study or program.
Ongoing work output will involve continual critical evaluation of
the development strategy to maintain a state-of-the-art development
plan that is competitive and consistent with the latest regulatory
requirements, proactive identification of challenges, and
development of contingency plans to meet them. Recommends high
impact global decisions. Responsible for monitoring and
interpreting data from ongoing internal and external studies,
assessing the medical and scientific implications and making
recommendations that impact regional and global development such as
"go/no go" decisions or modification of development plans or study
designs that may have a significant impact on timelines or product
labeling.
Synopsis / Protocol Development, Study Execution, & Study
Interpretation
Oversees all Clinical Science activities relating to the
preparation / approval of Synopses, Protocols and the conduct of
clinical studies. Serves as an advisor or supervisor to other
medical directors or clinical scientists involved in these
activities, and be accountable for the successful design and
interpretation of clinical studies. Interprets data from an overall
scientific standpoint as well as within the context of the medical
significance to individual patients. Presents study conclusions to
Management and determines how individual study results impact the
overall compound strategy.
Trial Medical Monitoring
Responsible for or overseeing 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 and, as applicable, medical
directors with respect to assessment of these issues. Makes final
decisions regarding study conduct related to scientific
integrity.
External Interactions
Directs interactions with key opinion leaders relevant to assigned
compounds and therapeutic area. Provides leadership in meetings and
negotiations with 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. Leads incorporation of advice /
recommendations received into the design of clinical studies and
programs as appropriate.
Due Diligence, Business Development and Alliance Projects
Responsible for evaluation of potential business development
opportunities and conduct of due diligence evaluations assessing
scientific, medical and development feasibility, evaluating
complete or ongoing clinical trials, and regulatory interactions
and future development plans. Leads the development and negotiation
of clinical development plans for potential alliances or
in-licensing opportunities, interacts with upper management of
potential partner/acquisition companies during due diligence visits
and alliance negotiations and represents clinical science on
internal assessment teams. For ongoing alliance projects, will
interface with partner to achieve Takeda's strategic goals while
striving to maintain good working relationship between Takeda and
partner.
Leadership, Task Force Participation, Upper Management
Accountability
Interacts with research division and other functions based on
pertinent clinical and development expertise to provide knowledge /
understanding of market environment in line with status as
scientific content matter expert for assigned compounds or disease
areas. Represents clinical science and contributes to or leads
internal task forces and Therapeutic Area internal teams, including
disease area units as well as global cross-functional teams as
appropriate. Hires, mentors, motivates, empowers, develops and
retains staff to support assigned activities.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education and experience
MD or internationally recognized equivalent plus 5 years of
clinical research experience within the pharmaceutical industry,
CRO health-related consulting company, or biomedical/clinical
experience within academia (or a combination of afore mentioned).
Previous experience successfully leading matrix teams. Skills
Superior communication, strategic, interpersonal and negotiating
skills Ability to proactively predict issues and solve problems
Ability to drive decision-making within a multi-disciplinary,
multi-regional, matrix teams Diplomacy and positive influencing
abilities Knowledge
Neurology therapeutic area knowledge desired Regional/global
Regulatory requirements GCP/ICH
TRAVEL REQUIREMENTS:
Ability to drive to or fly to various meetings or client sites,
including overnight trips. Some international travel may be
required.
Requires approximately -10 - 20% travel.
Absent an approved religious or medical reason, all US office-based
and lab-based Takeda employees who work fully on-site or in a
hybrid model (as determined by Takeda) must be fully vaccinated to
work at a Takeda site or to engage with Takeda colleagues or anyone
else on behalf of Takeda. US field-based employees must be fully
vaccinated as a condition of employment, absent an approved
religious or medical reason. US employees who work at a Takeda
manufacturing facility, and those who work at a BioLife center or
BioLife lab, may be subject to different guidelines. If you are
contacted by a Takeda recruiter about your job application, we
encourage you to seek more information on the applicable guidelines
for the Business Unit/Function to which you have applied.
This job posting excludes CO applicants.
WHAT TAKEDA CAN OFFER YOU:
--- 401(k) with company match and Annual Retirement Contribution
Plan
--- Tuition reimbursement Company match of charitable
contributions
--- Health & Wellness programs including onsite flu shots and
health screenings
--- Generous time off for vacation and the option to purchase
additional vacation days
--- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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
Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Somerville , Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit, Healthcare , Reading, Massachusetts
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