Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit
Company: Takeda Pharmaceutical
Location: Newfield
Posted on: May 12, 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.
---
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--- 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, Camden , Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit, Executive , Newfield, New Jersey
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