Executive Director, Global Clinical Development- Nephrology and Immunology

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Company: Otsuka Pharmaceutical Co., Ltd.

Otsuka is a global healthcare company with the corporate philosophy: “Otsuka people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.

Culture

As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning “creativity”, gives Otsuka people permission to do what’s never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.

Another Japanese tenet, Jissho-Shugi, means “earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities.” Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.

Pipeline

Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product’s full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.

You can learn more about Otsuka by clicking here!

Job Description

Otsuka is currently hiring for an Executive Director, Global Clinical Development – Nephrology & Immunology. The Global Clinical Development function has responsibility for helping to define the Global R&D strategy and direct responsibility for taking all compounds from proof of concept through to Regulatory Approval. This individual will have a specific focus on the Nephrology & Immunology therapeutic areas and manage all aspects on the clinical strategy.

The Executive Director of Global Clinical Development, Immunology/Nephrology will lead a team of five physicians and help to devise/guide the clinical strategy for the organization shaping the framework for clinical results which lead to product registration. As Otsuka continues to expand its focus in this therapeutic area it will continue an aggressive M&A and BD&L agenda. Therefore, this person will be asked to participate in the due diligence of potential acquisitions, in-licensing or joint-development programs for clinical viability and the potential for commercial success.

KEY RESPONSIBILITIES

In addition, the Executive Director will utilize his/her experience, gravitas and leadership to continuously provide ongoing education to Otsuka’s clinical efforts. The specific duties assigned to this role include, but are not limited to:

• Oversee and guide the development of clinical research programs over multiple trials in the US and/or Europe, as well as globally, if necessary.
• Design the clinical trial protocols for the leading compounds in clinical development with a patient-centric focus.
• Manage the relationship with relevant CROs to ensure study design and protocols, patient recruitment, and that trials are executed on time and within budget.
• Review the clinical operating plans and developing the clinical project team utilization plan.
• Monitor ongoing clinical safety of the products.
• Review Scientific manuscripts for publications.
• Oversee the budgets for the projects under development.
• Manage a team of clinical development physicians, with a particular focus on leadership and facilitating team solutions.
• Ensure compliance with FDA and any other relevant Regulatory Authorities.
• Evaluate the clinical data at decision/stage gate points.
• Serve as a true business partner to the organization by incorporating global corporate needs into development decisions, including activity for BD+L/M&A.

YEAR ONE CRITICAL SUCCESS FACTORS

This is a high-profile role within Otsuka Pharmaceuticals, and one in which the candidate must be comfortable operating in a complex matrixed global environment. Therefore, the ideal candidate will be expected to achieve the following objectives in their first year:

• Build mutually respectful relationships with colleagues in Japan and across the Otsuka US organization.
• Immediately gain an understanding of the business and ongoing clinical programs.
• Determine potential challenges and provide direction, guidance and support to the Nephrology/Immunology Clinical Development team to deliver on near and long-term goals.
• Review the CRO activity, contracting, and management process; improve quality and efficiency where needed.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

Otsuka Pharmaceutical Development & Commercialization, Inc. is seeking a seasoned clinical development leader with substantial Bio/Pharma industry experience, coupled with a track record of leading a global team to develop and advance an innovative pipeline including accomplishing successful regulatory filings and approvals. Specific experiences also include:

• Having a Clinical perspective coupled with a track record of achievement and management experiences in clinical development, with a strong preference towards Immunology or significant experience in an appurtenant/corresponding therapeutic area such as Nephrology.
• Demonstrated success in designing clinical trials that have led to NDA filings resulting in subsequent approval to registered products.
• Ability to operate in ambiguity.
• Ability to develop close working relationships with opinion leaders.
• Demonstrated ability to work collaboratively with multi-disciplinary teams and has proven abilities as an effective team leader; able to attract, develop and mentor others.
• Excellent project management skills; can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of goals.
• Excellent organizational skills.
• Scope for personal growth.

LEADERSHIP CHARACTERISTICS

Instills Trust

Gains the confidence and trust of others through transparency, integrity, and authenticity. Sets accurate expectations and follows through on commitments.

Drives Results

Drives for aggressive goals with a strong sense of urgency, even under tough circumstances, holding the organization to high standards and maintaining a keen focus on activities that will have a direct impact on business results.

Strategic Vision

Develops enterprise-wide strategies that are distinctive in the market, create value for customers and other stakeholders, and provide sustainable competitive advantage.

Engages and Inspires

Creates a culture that fosters performance excellence, personal engagement, meaningful contributions, and commitment to the organization’s vision and values.

Being Resilient

Maintains a positive outlook under pressure, sustains performance through setbacks and adversity, and rebounds from difficult situations.

Courage

Steps up to address difficult challenges, confront tough organizational issues, make unpopular decisions, forge new ventures, and champion change.

Navigates Networks

Makes it a priority to broker relationships and forge connections that can advance the goals of the organization.

Develops Talent

Ensures that the organization has the talent required to meet current and future business needs by bringing the best talent on board, developing internal capabilities, building a pipeline of successors, and deploying talent appropriately.

EDUCATION

A clinician (M.D., or D.O.) preferably a rheumatology / immunology background including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.

– Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline, 15+ years required

COMPENSATION

A competitive compensation package including salary, bonus and equity will be offered based upon background and experience.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status

Competencies
Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving – Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication – Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development – Play an active role in professional development as a business imperative.

Minimum $277,341.00 – Maximum $430,560.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.