Medical Director - Parsippany | Zoek USA | 000381
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Medical Director, Rare Genetic/Hematology Therapeutic Area Unit
Permanent (Full time)
- The Medical Director works with matrixed teams and functional leadership to develop and drives the strategy for the overall global clinical development of programs 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 tactical and strategic issues and decisions. This individual has the responsibility for 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. Applies clinical/medical decision making to clinical development issues. Consults systematically with senior managers in clinical science and other functional areas to align strategies for compound development plans and other projects.
- This individual interacts with and influences senior leadership decision-making for the projects by setting strategic direction as part of the Rare Genetics/Hematology Therapeutic Area Unit (RGH TAU). Success directly translates to the ability of RGH TAU to meet its strategic and operational research and development goals and for Takeda to have future commercial products that are innovative and differentiated to improve the health of patients.
- Clinical Development team participation and leadership
- Focus on Rare Genetic/Hematology disorders in both adults and children, and conditions in need of novel treatments from a medical and scientific perspective in early and/or late-stage development.
- Member of Global Clinical Sub-Team and study teams and actively collaborates with Japan & China teams to ensure that activities are aligned with global strategy.
- As a member of the clinical subteam, establishes and drives clinical strategy and deliverables in the context of the Global Project Teams Asset Strategy. Contributes to the generation of Clinical Development Plan and Clinical Concepts/Synopses/Protocols.
- Provides therapeutic area scientific expertise in the assessment of internal and external opportunities for clinical research to address the unmet medical needs of patients with Rare Genetic/Hematology conditions.
- Medical monitoring and data review and interpretation 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, approvability, 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, conduct, and interpretation of clinical studies. Presents study conclusions to Senior Leaders 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
- Key Takeda contact for sites and investigators; responsible for medical monitoring activities, assessing issues related to protocol conduct and/or 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. Interacts closely with study monitoring personnel from clinical research organizations who are partners in the planning and execution of clinical studies.
- Makes decisions regarding study conduct related to scientific integrity in collaboration with global team and functional leadership.
- External Interactions
- Participates 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, data monitoring committees, 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 (. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead role in 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
- Opportunities to participate in identification and evaluation of potential business development opportunities, the conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assess 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 on potential partner/acquisition companies during due diligence visits and alliance negotiations, and representing clinical science on internal assessment teams.
- May serve as clinical contact point for ongoing alliance projects and interface with partner to achieve Takedas strategic goals while striving to maintain good working relationship between Takeda and partner.
- Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with RGH Drug Discovery Unit (DDU) and RGH Business Unit based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as RGH TAU scientific content expert for assigned compounds and clinical evaluations. 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 drive goal setting and development planning.
- Coordinates, leads and delivers period department trainings including scientific literature reviews.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- MD or internationally recognized equivalent plus at least 5 years of experience within the pharmaceutical industry, CRO health-related consulting company, and/or clinical research experience as a faculty member within academia.
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies at multiple sites and in multiple regions, and/or management experience preferred
- Embraces life-long learning
- Patient-first approach to clinical development
- Superior communication, strategic, interpersonal and negotiating skills
- Strive to proactively predict issues and solve problems
- Strive to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
- Collaborative approach and positive influencing abilities
- Therapeutic area knowledge relevant to disease indication and mechanism of action of potential study drug(s)
- Understanding Good Clinical Practice (GCP) /International Conference on Harmonization(ICH)
- Emerging research in designated therapeutic area preferred
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
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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.