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 of 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
- 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
- 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.
- 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.
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.
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