Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology

Company: Takeda Pharmaceutical
Location: Newark
Posted on: May 13, 2022

Job Description:

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Job Description
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.

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 area

TRAVEL 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 Programs

Empowering Our People to Shine
Discover more at takedajobs.com
This job posting excludes CO applicants.
No Phone Calls or Recruiters Please.

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 , Medical Director/Senior Medical Director, Clinical Science, Rare Genetics & Hematology, Executive , Newark, New Jersey