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VP & Head of Integrated Development Associates (IDA)

Covance 9/21/2018 5:54:59 AM
JOB ID: 24085 Category: Executive
Tokyo, Japan

   

 

Job Overview

Covance is currently searching for a Head of Integrated Development Associates (IDA), a Covance company. This Japan based leader will provide the overall strategic, financial, organizational and operational leadership of IDA in coordination with the Clinical Development and Commercialization Services (CDCS) global and regional functional line management as well as Covance support groups (IT, HR, Finance, Marketing, and Sales), to succeed in leading and executing the following functions and initiatives for Covance:

* Japan strategic development initiatives focused on comprehensive facilitation of Japan market entry strategies for agile biopharma without a significant base of Japanese operations
* Develop Pan Asian strategic development initiatives focused on comprehensive facilitation of Asian market entry strategies for biopharma without a significant base of Asian operations
* Management of high level relationships with Japanese regulatory and governmental bodies (PMDA, MHLW, legislative, etc.) on behalf of IDA and Covance
* Establishment and management of Key Opinion Leaders (KOLs) panels in order to assess the medical positioning of products in Japan and Asia and to gain support and advocacy for proposed development strategies
* Lead strategic regulatory interactions with PMDA and MHLW (and oversee Pan Asian regulatory dialogues where appropriate) to gain endorsement of optimal pathways for Japanese and Pan Asian product development
* Collaborate closely with Covance Global Regulatory Affairs on global development strategies for agile biopharma and other clients
* Establish, maintain and grow a platform for implementation:

1. of Phase 1 ethno-bridging studies in Japanese, Chinese and Korean populations to enable conduct of Phase 2/3 clinical trials in Asian countries requiring nationality specific clinical trials
2. of an In-Country Clinical Caretaker (ICCC) platform capable of enabling biopharma without a base of operations in Japan to conduct clinical trials in Japan compliant with Japanese regulatory and legislative requirements
3. for implementation of clinical trials in Japan/ Asia through an internal IDA team of Program Managers and Clinical Trial Managers (CTMs) that work seamlessly with the regulatory strategy and ICCC teams mentioned above to ensure flawless implementation of strategic development for biopharma clients as part of overall program delivery
4. for partnering with local Japanese CROs to augment Covance Japan CRA and operational resources

* Support all ICCC needs for global and regional studies being conducted in Japan by Covance
* Identify potential CROs partners and acquisition targets that can contribute to the growth of Covance in Japan and play a key role in maintaining relationships and the process of establishing an acquisition strategy and negotiations
* Identify and negotiate agreements with companies that can partner with Covance biopharma clients in successfully partnering their assets for Japan and Asia

To successfully achieve these goals the new leader will have responsibility for:

Commercial Acumen

* Has a deep understanding of the industry, market, and our clients, and leverages that Experience to grow a portfolio of innovative and profitable business
* Owns client expectations and satisfaction; identifies, develops and fosters new and existing strategic relationships at executive levels with clients, KOLs, Vendor Partners etc., and guides team in building long-term strategic client relationships
* Leads high quality end-to-end business development strategies, including RFI response, proposal development, bid defense preparation and presentations
* Markets and supports capability, visibility and position through publications and presentations at conferences, meetings and webinars etc.
* Drive growth, ensuring financial results and other assigned metrics, are met or exceeded
* Develop operational plans to achieve strategic objectives for the business, and revise as necessary
* Ensure project management milestones and service delivery goals are met or exceeded
* Facilitates new and existing relationships at senior operational levels with vendor partners, industry consultants, among other stakeholders, and guides teams in delivering to establish/maintain effective client relationships
* Ensure client satisfaction survey scores are driven to as high a level as possible, and serve as point of escalation for resolution of client issues
* Provide guidance and feedback to matrixed support groups involved in providing services
* Ensure appropriate resource distribution for work contracted by clients
* Work with other business units to identify and deliver integrated service solutions for clients

Leadership

* Select, motivate, and facilitate the professional development of employees generally, and its leadership team in particular
* Engages with IDA and other Covance leadership to help drive and implement initiatives, including cross-functional integrated opportunities, to grow and expand the contact center, consulting organization and clinical
* Leads by Example in building and sustaining a scalable organization; creates a forward-looking culture of ownership and accountability; delegates for development and growth; identifies and sets up high performers for success; is self-aware and a learner
* Effectively leads in a global, complex environment; sets clear expectations; coaches and mentors for success; consistently communicates and connects; cultivates a continuous learning environment

Operational Leadership and Financial Acumen

* Owns global P&L (revenue, margin, budget, forecasting, write-offs, fixed-price gains, expense management, resources etc.)
* Accountable for portfolio growth and delivery, encompassing consistent quality, assuring both patient safety and GCP compliance
* Ensures allocated resources are aligned with current and projected work in terms of capability, quantity, timing, efficiency
* Oversee all facility and administrative planning
* Responsible for outcomes of affirmative action, diversity, organizational and leadership development and communication programs

Education/Qualifications

* Bachelor's degree required
* Advanced degree (MBA, PhD) preferred

Experience

Minimum Required:

* 15 or more years of Japanese and global business, pharma/CRO industry, consulting and regulatory Experience
* Demonstrated ability to be effective in a matrixed environment
* Broader level client relationships and business development Experience
* Deep Experience with Japanese regulators and government and ability to forge sophisticated relationships with Asian regulatory/ governmental bodies
* Proven vision, strategy, and growth Experience
* Fluent in English and Japanese


Position Type: Full-Time

Location: Tokyo, JPN - Japan



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Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).