Senior Medical Director, Clinical Sciences

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Senior Medical Director, Clinical Sciences

24 Nov 2024
Massachusetts, Boston, 02108 Boston USA
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Senior Medical Director, Clinical Sciences

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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionSenior Medical Director, Clinical SciencesCambridge, MAHybridOBJECTIVES/PURPOSEThe PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases.The Senior Medical Director – Hematology, Neuroimmunology & Specialty Care (HNSC) leads and drives strategy for the overall global (US/EU/Japan/ other regions and countries) clinical development for Specialty Care products, specifically focusing on development of products targeting indications in Nephrology and/or Transplant Medicine. The candidate will apply their expertise in Nephrology and/or Transplant medicine to clinical development, taking into consideration the medical, scientific, regulatory, and commercial perspectives. They will lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility and accountability for development decisions assessing and integrating the input from various disciplines to create and maintain a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development processes. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.ACCOUNTABILITIES

Clinical Development team participation and leadership

Leads nephrology/transplant medicine clinical development for a given product and/or indication and represents Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.

Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity, and size, which influence the budget of 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.

Responsible for high impact global decisions with respect to nephrology/transplant medicine: monitoring and interpreting 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 will have a significant impact on timelines or product labeling. Plans clinical development plans or study designs that will have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.

Synopsis / Protocol Development, Study Execution, & Study Interpretation

Drives nephrology/transplant medicine clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall product 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 and/or individual subject safety. Assesses overall safety information for studies and products in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.

Makes decisions regarding study conduct related to scientific integrity.

External Interactions

Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders in nephrology/transplant medicine relevant to assigned products in PDT R&D. Direct interaction with PIs who are nephrologists or transplant medicine specialists in support of clinical development activities will be required. Provides leadership and serves as an advisor to the others engaged in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.

Due Diligence, Business Development and Alliance Projects

Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses 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.

Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D’s strategic goals while striving to maintain good working relationship between Takeda PDT BU and partner. Provides guidance to others who are involved in some of these activities.

Leadership, Task Force Participation, Upper Management Accountability

Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. Represents clinical science on high impact/priority task forces across the organization or external to the company. Leads PDT R&D internal teams and 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, as appropriate.

DIMENSIONS AND ASPECTSLeadership

Global perspective with a demonstrated ability to work across functions, regions, and cultures

Ability to identify potential challenges and opportunities and make recommendations

Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company

Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization

Invests in helping others learn and succeed

Able to influence without authority at senior levels

Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.

Decision-making and Autonomy

Accountable for acting decisively and exercise sound judgment in making decisions with limited information

Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence

Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities

Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution

Develops executable plans and meets budget and deadlines

Builds a culture of data driven decisions

Interaction

Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU

Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions

Strong communicator, able to persuasively convey ideas verbally and in writing

Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders

Innovation

Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities

Continuously challenging the status quo and bringing forward innovative solutions

Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

Delivers solutions to abstract problems across functional areas of the business.

Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.

Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.

Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity

Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy

Resilient and comfortable working through large scale global change management

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

M.D. or internationally recognized equivalent degree is required. Additional advanced degree, e.g., Ph.D. is desired.

Expertise and significant experience in Nephrology, Transplant Medicine (solid organ or bone marrow transplantation), or related specialty required. Specialty certification in nephrology, transplant medicine, or related specialty is desired.

3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.

Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions is desired. Development experience beyond US/EU is desired.

Deep medical knowledge and experience in patient care and/or academia and good publication record is desired.

NDA/MAA Submission experience preferred

Management experience is preferred

Skills

Superior communication, strategic, interpersonal, and negotiating skills

Ability to proactively predict issues and solve problems

Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams

Diplomacy and positive influencing abilities

Knowledge

Knowledge/experience in Nephrology, Transplant Medicine, or a related specialty, disease mechanisms and plasma derived/related therapies

Regional/global Regulatory requirements

GCP/ICH

Emerging research in plasma derived/related therapies

LICENSES/CERTIFICATIONS:

Physician and Surgeon Medical License or equivalent

Board certification/s in Nephrology, Transplant Medicine, or a related specialty is desired

TRAVEL REQUIREMENTS:

Ability to drive to or fly to various meetings or sites, including overnight trips. Some international travel may be required.

Requires approximately 10 – 20% travel.

What Takeda can offer you:

Comprehensive Healthcare: Medical, Dental, and Vision

Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

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 and company match of charitable contributions

Family Planning Support

Flexible Ways of Working

Tuition reimbursement

More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.#LI-hybridTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:256,200.00 - 402,600.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.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 timeJob ExemptYes

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