Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 2022
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAre 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
StatementTakeda 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.LocationsCambridge, MAZurich, SwitzerlandWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Associate Medical Director/Medical Director, Clinical Science, Neuroscience Therapeutic Area Unit, Executive , Cherry Hill, New Jersey
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