Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology
Company: Takeda Pharmaceutical
Location: Great Meadows
Posted on: May 13, 2022
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Are 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.
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
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.
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
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
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
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
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
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
Experience leading a clinical development team/matrix team with
responsibility for studies in multiple regions.
NDA/MAA/Submission experience preferred.
Therapeutic area knowledge relevant to mechanism of action is
Clinical trialist experience
Regional/global regulatory requirements
Latest research in designated therapeutic area
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
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
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
This job posting excludes CO applicants.
No Phone Calls or Recruiters Please.
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.
Keywords: Takeda Pharmaceutical, Bethlehem , Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology, Executive , Great Meadows, Pennsylvania
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