Executive Medical Director, Cold to Hot
Company: Takeda Pharmaceutical
Location: Highland Park
Posted on: May 9, 2022
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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?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: -The Senior
Medical Director leads and 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 ultimate responsibility for development
decisions assessing and integrating the input from various
disciplines to create, maintain, and execute a global clinical
development plan of assigned compound(s) in multiple regions as
well as inform the value drivers required for reimbursement.
Applies clinical/medical decision pertaining 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.ACCOUNTABILITIES: -Clinical Development team
participation and leadership with focus on the Cold to Hot
platform. Leads Global (US/EU/Japan) Clinical Sub-Team and oversees
Japan & Asia Clinical Sub-Team to ensure that activities are
aligned with the global strategy. As a member of the Global Program
Team (GPT), establishes and drives Clinical Sub-Team strategy and
deliverables in the context of the GPT's Asset Strategy; leads the
generation of the Clinical Development Plan and Clinical Protocols.
- Recommends scope, complexity and size, and influence the budget
of all aspects of a program. - Provides continual critical
evaluation of the Asset 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.Responsible for
high impact global 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 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: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 and more junior medical directors 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. 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 medical monitoring activities, assessing
issues related to protocol conduct and/or individual subject
safety, in partnership with CRO responsible for trial delivery. -
Assesses overall safety information for studies and compound in
conjunction with Pharmacovigilance. - Oversees medical and
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. - 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
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 directly with Oncology DDU and Oncology
Business Unit based on 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.
Hires, manages, mentors, motivates, empowers, develops and retains
staff to support assigned activities. Conducts performance reviews
and drive goal setting and development planning.Coordinate, lead
and deliver periodic departmental trainings.EDUCATION, EXPERIENCE,
KNOWLEDGE AND SKILLS: -MD or internationally recognized equivalent,
plus 5 years of clinical research experience within the
pharmaceutical industry, or relevant biomedical/clinical experience
within academia.Previous experience successfully leading a clinical
development team/matrix team with responsibility for studies in
multiple regions.Oncology training (fellowship or internationally
recognized equivalent) preferred.Experience working with early
stage oncology assets preferred.Management experienceSuperior
communication, strategic, interpersonal and negotiating
skillsAbility to proactively predict issues and solve
problemsAbility to drive decision-making within a
multi-disciplinary, multi-regional, matrix teamsDiplomacy and
positive influencing abilitiesTherapeutic area knowledge relevant
to mechanism of actionRegional/global Regulatory
requirementsGCP/ICHEmerging research in designated therapeutic
areaTRAVEL 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 -
25% travel.Effective November 1, 2021, 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. As of the same date, absent an approved religious or
medical reason, US field-based employees, employees must be fully
vaccinated in order to continue in their current roles. - 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. Candidates are encouraged to speak with their
recruiter to seek further information on the applicable guidelines
for the Business Unit/Function for which they 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.WHAT TAKEDA CAN OFFER YOU:
Keywords: Takeda Pharmaceutical, Elizabeth , Executive Medical Director, Cold to Hot, Healthcare , Highland Park, New Jersey
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