Kelly Services Job - 44832860 | CareerArc
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Company: Kelly Services
Location: Boston, MA
Career Level: Director
Industries: Recruitment Agency, Staffing, Job Board

Description

Medical Director (MD) Part-Time
***
The Medical Director will be responsible for the clinical management of a Phase 1 Solid Tumor study, and will contribute to development of future studies. Oncology experience required***

OBJECTIVES:

The Medical Director leads and drives strategy for the overall regional (US/EU) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compound(s). Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences GPT decision-making by setting strategic direction independently. Success or failure directly translates to the ability of GPT to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES:

Clinical Development team participation and leadership

o Represents Clinical Science on global Development Teams and will serve as medical science leader of this team. Supports the delivery of the study to ensure the progress of the Global Development Team (US, EU, Japan) to ensure that the global Development Team activities are aligned with the global drug development strategy. May act as Global Development Team (US, EU, Japan) Leader managing both the GLOBAL Development Team and the Japan Development Team for an early or a smaller scope product.

o Responsible for providing support to the GCL (Global Clinical Lead) for global development plan. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Ongoing work output will involve 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. Recommends high impact global decisions. Responsible for 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 may 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

o Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to CRO and other cross-function team member involved in these activities, and be accountable for the successful design and interpretation of clinical studies independently. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.

o Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients independently.

Trial Medical Monitoring

o Responsible for overseeing medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety independently. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.

o Accountable on final decisions regarding study conduct related to scientific integrity with the support of GCL

External Interactions

o Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with 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 independently. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.

Due Diligence, Business Development and Alliance Projects

o Responsible for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.

o Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. For ongoing alliance projects, will 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

o Interacts with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science and leads internal task forces and TGRD internal teams as well as global cross-functional teams as appropriate.

o Mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.



You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

]] About Kelly Services

Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.

Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.

Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.


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