Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology
Company: Takeda Pharmaceutical
Location: Teaneck
Posted on: May 14, 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 to inspire and empower you? At Takeda, we
empower our people to work towards their potential through
life-changing work. Certified as a Global Top Employer, we offer
stimulating careers, encourage innovation and work toward
excellence in everything we do. We foster an inclusive and
collaborative workplace, in which our global teams are united by an
unwavering commitment to provide Better Health and a Brighter
Future to people around the world.As the Medical Director/Senior
Medical Director, Clinical Science, Rare Genetics and Hematology
you will report to the Head - VP Clinical Science, Hematology in
our Cambridge, MA office.OBJECTIVES:
- The Medical Director/Senior Medical Director leads and guides
strategy for the global (US/EU/Japan) clinical development taking
into consideration the medical, scientific, regulatory and
commercial issues for assigned Takeda pipeline compounds.
- You will lead a diverse, multi-regional, matrix team through
complex decisions. You will have the ultimate responsibility for
development decisions assessing and integrating the input from
multiple disciplines to create a global clinical development plan
to result in the regulatory approval of the assigned compound in
multiple regions.
- Reports directly to the Head of Clinical Sciences, Rare
Genetics and Hematology or designee with matrix reporting to the
Global Program Leads for assigned
programs.ACCOUNTABILITIES:Clinical Development team participation
and leadership
- Lead the Global (US/EU) Clinical Sub-team working with TDC-Asia
and TDC-Japan to build a global program for a given product. Seek
Clinical Science functional understanding and represent Clinical
Science on the Global (US/EU) Project Team to ensure that
activities are aligned with the global strategy and partners.
- Establish and guide Clinical Development strategy and
deliverables contributing to the Asset Strategy, the Clinical
Development Plan and Clinical Protocols. Recommend scope,
complexity and size, and influence the budget for all aspects of a
program. Provide essential evaluation of the development strategy
to maintain a development plan that is consistent with the latest
regulatory requirements, identification of challenges, and
development of contingency plans to meet them.
- May oversee medical monitors and clinical scientists in the
clinical development plan and clinical trials, providing mentoring,
development opportunities, insights and support.
- Monitor and interpret data from ongoing studies, assessing the
medical and scientific effects, and making recommendations that
impact 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
- Bring clinical science activities relating to the preparation /
approval of synopses, protocols and the conduct of clinical
studies. Be an advisor to other clinical scientists involved in
these activities, and oversee the successful design and
interpretation of clinical studies. Present study conclusions to
Management and determines how individual study results affect the
compound strategy.
- Interpret data from an overall scientific standpoint and within
the context of the medical significance to individual
patients.Trial Medical Monitoring
- Oversee medical monitoring activities, assessing issues related
to protocol conduct, clinical data quality, and individual subject
safety. Assess overall safety information for studies and compound
together with Pharmacovigilance. Oversee non-medical clinical
scientists concerning assessment of these issues.
- Make final decisions regarding study conduct related to
scientific integrity.External Interactions
- Work with team members on activities involved in interactions
with regulatory authorities / agencies and clinical development
activities undertaken to establish relationships with essential
opinion leaders relevant to assigned compounds and therapeutic
areas.Due Diligence, Business Development and Alliance Projects
- May be asked for participation in the identification and
evaluation of potential business development opportunities,
conducting due diligence evaluations, and development and
negotiation of clinical development plans for potential alliances
and in-licensing opportunities. Responsibilities may include
assessment of scientific, medical, and development feasibility,
evaluating strategic fit with portfolio, evaluating complete or
ongoing clinical trials, assessing regulatory interactions and
future development plans, working with upper management of
potential partner/acquisition companies during DD visits and
alliance negotiations, and representing clinical science on
internal assessment teams.EDUCATION, BEHAVIOURAL COMPETENCIES AND
SKILLS:
- MD or internationally recognized equivalent plus 5 or more
years of clinical research experience in the pharmaceutical
industry, CRO health-related consulting company, or
biomedical/clinical experience within academia (or a combination of
afore mentioned).
- Experience leading a clinical development team/matrix team with
responsibility for studies in multiple regions.
- NDA/MAA/Submission experience preferred.
- Management experience.
- Therapeutic area knowledge relevant to mechanism of action is
desired
- Clinical trialist experience
- Regional/global regulatory requirements
- GCP/ICH
- Latest research in designated therapeutic areaTRAVEL
REQUIREMENTS:
- Requires approximately 15 - 25% travel to different meetings or
client sites, including overnight trips. Some international travel
may be required.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.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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comThis job posting excludes CO
applicants.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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Paterson , Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology, Executive , Teaneck, New Jersey
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