Medical Director/Senior Medical Director, Clinical Science- Rare Genetics and Hematology
Company: Takeda Pharmaceutical
Location: Quincy
Posted on: May 9, 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 a Medical Director/Senior Medical Director in our
Cambridge, MA 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 Medical Director/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; applies
clinical/medical decision making to clinical development
issues.
- 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 that will 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.
- This individual interacts with and influences Takeda Global
R&D and Takeda Pharmaceutical Company senior leadership
decision-making by setting strategic direction for assigned
projects.POSITION ACCOUNTABILITIES:
- Clinical Development team participation and leadership
- Leads the Global (US/EU) cross-functional Clinical Sub-team
working closely with TDC-Asia and TDC-Japan to build and execute on
a global program for a given product. Seeks Clinical Science
functional alignment and represents Clinical Science on the Global
(US/EU) Project Team to ensure that activities are aligned with the
global strategy and key stakeholders
- Establishes and drives Clinical Development strategy and
deliverables contributing to the Asset Strategy, the Clinical
Development Plan and Clinical Protocols. - Recommends scope,
complexity and size, and influences the budget for all aspects of a
program. - Provides 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.
- May oversee medical monitors and clinical scientists in the
execution of the clinical development plan and clinical trials,
providing mentoring, development opportunities, insights and
support
- Monitors and interprets 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
involved in these activities, and is accountable for the successful
design and interpretation of clinical studies. - Presents study
conclusions to Management and determines 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, clinical data quality, and individual
subject safety. - 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
- Works cross-functionally and collaboratively with team members
on 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
- 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 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.
- May be asked to serve 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 research division based on pertinent
clinical and development expertise and with commercial to provide
knowledge / understanding of market environment in line with status
as scientific content matter expert for assigned compounds. - May
represent clinical science on multidisciplinary task forces across
divisions - - -Lead 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 drives goal setting and development planning.EDUCATION,
BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus 5-10 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 a clinical development
team/matrix team with responsibility for studies in multiple
regions.
- NDA/MAA/Submission experience desired.
- Management experience.Skills
- Superior communication, strategic, interpersonal and
negotiating skills
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within multi-disciplinary,
multi-regional, matrix teams
- Diplomacy and positive influencing abilitiesKnowledge
- Therapeutic area knowledge (neurology, rare diseases,
pediatrics) relevant to mechanism of action is desired
- Passion for research is essential
- Clinical trialist experience/knowledge is essential
- Lifelong learner
- Understanding of regional/global regulatory requirements is
desirable
- GCP/ICH
- Emerging research in designated therapeutic areaAbsent 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 ProgramsEmpowering Our People to
ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters
Please.#LI-JV2EEO 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.LocationsUSA - MA - CambridgeWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Quincy , Medical Director/Senior Medical Director, Clinical Science- Rare Genetics and Hematology, Executive , Quincy, Massachusetts
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