Senior Medical Director, Hematological Malignancies, Oncology Clinical Science
Company: Takeda Pharmaceutical
Location: Newark
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?
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.
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.
OBJECTIVES/PURPOSE
The Senior Medical Director drives strategy for the overall global
(US/EU/Japan) 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 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 as well as
inform the value dossiers required for reimbursement.
Applies clinical/medical decision making to clinical development
issues. This individual interacts with and influences Oncology
Therapeutic Area Unit and Takeda R&D senior leadership
decision-making for the projects by setting strategic direction.
Success or failure directly translates to the ability of Takeda
R&D to meet its corporate goals and for Takeda to have future
commercial products.
May serve as Global Clinical Leader of individual therapeutic
programs
ACCOUNTABILITIES .
Clinical Development team participation and leadership
Focus on hematological malignancies and solid tumor platforms.
Develops Clinical Sub-Team strategy and deliverables in the context
of the GPT's Asset Strategy; works collaboratively to generate the
Clinical Development Plan and Clinical Protocols.
Responsible for high impact decisions: 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. - A significant error
in judgment may result in loss of approvability and commercial
viability of a product.
Synopsis / Protocol Development, Study Execution, & Study
Interpretation
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.
Interprets data from an overall scientific standpoint as well as
within the context of the medical significance to individual
patients.
Trial Medical Monitoring
Responsible for performing or overseeing medical monitoring
activities, assessing issues related to protocol conduct and/or
individual subject safety, in partnership with the CRO responsible
for trial delivery. - Assesses overall safety information for
studies and compound in conjunction with Pharmacovigilance. -
Oversees non-medical clinical scientists with respect to assessment
of these issues.
Makes final decisions regarding study conduct related to scientific
integrity.
External Interactions
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. - Works with
Medical Affairs in interactions with investigator-initiated
clinical studies. 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.
Due Diligence, Business Development and Alliance Projects
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.
Serves as clinical contact point for ongoing alliance projects and
interface with partners 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 directly with Oncology DDU and Oncology Business Unit
using pertinent clinical and development expertise to provide
knowledge / understanding of market environment in line with status
as OTAU scientific content matter expert for assigned compounds. -
May represent clinical science on multidisciplinary task forces
across divisions. - - Lead Takeda R&D internal teams and may
lead global cross-functional teams, as appropriate.
Manages, mentors, motivates, empowers, develops and retains staff
to support assigned activities. Conducts performance reviews and
drive goal setting and development planning.
Coordinates, leads and delivers periodic departmental
trainings.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MD degree, 15+ year related work experience
Sufficient grounding in the principles of the scientific method and
cancer biology and experience in oncology drug development and
regulatory sciences sufficient to lead internal and external
projects relevant to the Oncology TAU across the spectrum of R & D
(early and late phase, LCM).
Previous experience successfully leading a clinical development
team/matrix team with responsibility for studies in multiple
regions. Global experience preferred.
NDA/MAA/Submission experience preferred.
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
Effective leadership behavior
Knowledge
Therapeutic area knowledge relevant to mechanism of action
Regional/global Regulatory requirements
GCP/ICH
Emerging research in designated therapeutic area
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 15% travel.
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
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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
Base Salary Range: $ Range Min to $ Range Mid, based on candidate
professional experience level. - Employees may also be eligible for
Short Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off.
This posting is made in compliance with Colorado's Equal Pay for
Equal Work Act, C.R.S. - 8-5-101 et seq.
Empowering Our People to Shine
Discover more at takedajobs.com
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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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Newark , Senior Medical Director, Hematological Malignancies, Oncology Clinical Science, Executive , Newark, New Jersey
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