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Otsuka America, Inc. · 17 hours ago

Executive Director, Global Clinical Development Program Lead

Rockville, MD

Full-time

Hybrid

Director/Executive

$250K/yr - $388K/yr

10+ years exp

Otsuka is a pharmaceutical company that specializes in clinical development and commercialization of health-care products. They are seeking an Executive Director to lead the Global Clinical Development Program for a portfolio of novel serotonergic agonists, overseeing strategy, development, and delivery while ensuring effective collaboration with stakeholders.

Consumer GoodsDietary SupplementsPharmaceutical

Comp. & Benefits

Responsibilities

Establish & continually evolve global portfolio strategy indications/sequencing. Align with Product Development Committee (PDC) and the Early Development Team (EDT) based on internal strategy and competitive landscape

Recommend individual asset strategies that supports a differentiated product profile including proposed go/no-go criteria (early to late phase)

Broader portfolio evidence generation strategy

Align COA endpoint development and validation work across individual assets

Drive portfolio-wide stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio

Drive internal and external communication strategy

Develop and continually evolve differentiated global go-to-market strategy based on unique attributes of assets within the portfolio:

Reimbursement and coding coverage

Broader portfolio global commercialization assessment/planning to drive asset’s global CDP

Patient support/wrap around services

Provide overall portfolio asset prioritization and support for discovery programs and indication selection

Set overarching regulatory strategy and endorse individual asset strategies as needed

Endorse proposed go/no-go criteria and support PDC for action points and EDTs for governance engagement for portfolio assets

Endorse CDPs for discovery/early stage and late-stage programs

Portfolio KOL engagement & patient advocacy strategy

Serve as the primary point of contact for key partners, ensuring collaborative and productive relationships

Drives the asset’s initial indication development strategy, including scientific, regulatory, and clinical access

Drives asset/brand vision and strategy through all lifecycle development activities, including registrational studies, as well as post-marketing studies

Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration by developing target product profile, developing initial indication label in-line with target profile, and creating economic value dossier

Oversees and adheres to the governance processes for the selected asset and drives the achievement of key milestones

Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other team members, and to external regulatory agencies

Constantly seeks innovative ways to grow the value of the asset throughout the product lifecycle by leveraging the team’s experience and skillset

Co-leads regulatory filing activities through NDA. Provides strategic direction to ensure concise, clear and convincing argumentation in all written and verbal communications

Recommends Business Development activities necessary for optimization of the portfolio value i.e., provide development perspective during due diligence or recommend opportunities that can help further support the specific portfolio group of assets

Sets vision for the Product Development Team and ensures the matrix team remains aligned and engaged toward that vision

Oversees relevant sub-teams and ensures clear goals are aligned with development team short- and long-term and performance standards are in place. Provides feedback and coaching and holds sub-team leaders accountable for key deliverables

Manages performance across the matrix team, in collaboration with the functional leaders

Demonstrates peer-to-peer influence across R&D functional leadership

Establishes trusting relationships locally and globally across the enterprise to advocate for the asset

Manages integration points and communications with key stakeholders across all Otsuka functions and market areas to ensure alignment and minimize risk

Monitor and manage contractual obligations, performance metrics, and governance structures

Ensures appropriate decisions are made in a timely manner and effectively navigates relevant governance to keep stakeholders informed and aligned while driving outcomes

Builds and manages relationships with external stakeholders (Opinion Leaders, Patient advocacy leaders, health authorities)

Support interpretation of key clinical trial results, regulatory feedback and other relevant information and lead the integration of these new findings into the cross-functional asset strategy

Qualification

Drug development processRegulatory strategyClinical trial managementCross-functional leadershipHealth economicsMarket access pathwaysPediatric drug developmentAnalytical problem solvingStakeholder engagementMicrosoft Office SuiteScientific consultingCommunication skillsTeam collaborationPresentation skills

Required

A minimum of 10 years of experience in the pharmaceutical industry, extensive working knowledge in the drug development process with proven progression in relevant R&D roles and significant experience in related therapeutic areas as well as pediatric drug development

Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully

Understanding of regulatory policies and impact of public relations (US and Global preferred)

Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships

Abreast of scientific issues as they impact business development and strategic planning

Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets

Understanding of regulatory policies and impact of public relations

Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working

Success in effectively communicating and influencing decisions with senior management

Ability to navigate through ambiguous and changing healthcare landscape

An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)

Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing

Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings

Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies

Willingness to travel 35% of time, over weekends and ability to travel internationally