Executive Director, Global Clinical Development- Nephrology and Immunology

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.

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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.

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.

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