Senior Director, Early Development Team Lead

Senior Director, Early Development Team Lead

Role Summary :

The Early Development Team (EDT) Lead is a critical role working to deliver Otsuka's pipeline and bring differentiated medicines to patients. The EDT Leader will lead asset focused multi-disciplinary teams from pre-clinical through demonstration of clinical proof of concept through to late stage development. The EDTL will be accountable to Early Development leadership and will lead EDTs to : (i) craft a vision, strategy and development plan for early assets (ii) develop a set of objective progression criteria for each asset advancing through the Otsuka pipeline (iii) deliver the programs to the organization and (iv) evaluate opportunities to build value in the pipeline.

Key Role Accountabilities :

Strategy & Execution - Leads Early Development teams to deliver early phase assets through clinical PoC, that supports go / no-go decisions for further development. Engages EDT members and cross company stakeholders to devise and implement an agreed development strategy for early phase portfolio assets through clinical PoC, aligned with late phase Development and Commercial. Effectively engages with and utilizes governance and advisory bodies to agree, revise and progress asset development plans proposed by the EDTs. Continually analyzes, progresses, and engages EDT members and stakeholders to solve problems and deliver data-driven decisions. Ensures that the EDT delivers to Full Development assets that meet robust Target Reimbursable Product Profiles that can achieve pricing, reimbursement, access and puts forward recommendations when these criteria cannot be met. Ensures the process and output of the team meets set milestones, within timelines & budget while remaining cognizant of opportunities to streamline development without compromising quality. Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities.

Leadership & Matrix Alignment - Works with EDT to set goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the matrix to accomplish the asset development plan. Oversees relevant sub-teams and ensures clear goals and objectives are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables. Facilitates objective and effective decision making among team members. Builds productive relationships with functional heads of all groups that interact with the EDT, and partners with them to advance the EDT goals and secure resources. Communicates key program information, risks, and milestones, and ensures information flow across key stakeholders, governance teams, functional leaders, team members, etc.

Experiences and expertise required :

MD, PhD, DVM, PharmD, MBA, or equivalent advanced biology degree Experienced drug developer with 10+ years experience in the drug development process, preferably with experience in early phase development covering both biologics and small molecule Experience in managing and leading high performance, cross-functional teams (Matrix) or complex organizations. Objective matrix team leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view Strong understanding of relevant regulatory health authority expectations and regulations for drug development Working knowledge of all functional areas of exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME / DMPK, early clinical development, etc. Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry Ability to multitask across multiple exploratory development assets. Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries Ability to review and interpret scientific data and incorporate emerging information, feedback and scientific progress (internal and external) into development actions.

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, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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 (EEAccommodations@otsuka-us.com) .

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.