The Head of Clinical Analytics for Data & Analytics (D&A) is accountable to the scientific and strategic analytical direction and delivery of the Clinical Development portfolio goals in partnership with the cross-functional Development leaders. This role will drive the goals for Clinical Analytics focusing primarily on R&D registrational objectives. This role oversees the data sciences, biostatistics, clinical programming and clinical data management capabilities and will lead these essential capabilities in an integrated manner that optimizes the delivery of the clinical data strategy.
Reporting to the Chief Data & Analytics Officer (CDAO), and a member of the D&A Leadership Team, this leader will become a driving force of change and delivery across the Data & Analytics organization.
Provide leadership, oversight and technical/scientific direction to the Clinical Analytics organization. A high functioning Clinical Analytics organization would be expected to deliver on both, strong scientific engagement and operational excellence. Specific areas of focus would be inclusive but not limited to the following: efficient and effective trial design and planning, stratification and enrichment considerations, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and presenting.
In support of the Clinical Development strategy, this role will provide scientific review of materials, inclusive of but not limited to protocols, analysis plans, health authority submission documents, publication materials, etc.. In addition, external scientific interactions will be a core accountability, including but not limited to health authority interactions.
Operational excellence would be demonstrated through the effective and efficient delivery of the Clinical Development portfolio. This includes but is not limited to the resourcing, prioritization, timeline management, functional outsourcing, etc...
Participates in Clinical Development portfolio governance and provides insights and strategic direction based on scientific principles, regulatory guidances/precedence and competitive considerations.
Contributes to D&A departmental governance reviews of portfolio and prioritization discussions. Regular monitoring and reporting on the operational health of Clinical Analytics, through the use of scorecard and metrics reflecting the functional performance of financials, quality and cycle-time.
Develop and lead the digital strategy for clinical data that is generated through traditional data capture mechanisms as well as through digital mechanisms (e.g. mHealth).
Function as a knowledge base and resource to project teams. Serves as a point of escalation and resolution for the Clinical Analytics organization and Clinical Development portfolio.
Models and coaches scientific engagement best practices that enable thought partnership and engender a collaborative environment with robust debate. Furthering the partnership and impact of Biostatistics at Otsuka.
Fosters a culture that focuses on the achievement of goals and personal accountability, through the setting of goals and expectations, the monitoring to plan and the redirection as needed and the celebration of achievements.
Fosters a culture that embraces the strategic use of data into decision making through the demonstration of the value data can provide with essential direction enabling greater business outcomes.
Builds a learning culture within and external to Clinical Analytics, where individuals are provided growth and development opportunities. Drive broad knowledge sharing activities through the use of external expert lectures and trainings as well as internal sharing activities.
Accountable for ensuring collaborations and communications with key stakeholders to Clinical Analytics.
Attract, retain, develop and promote talent to build a team with an optimal balance of experience and diverse perspectives.
As a member of the D&A Leadership Team, models the balance of innovation and intellectual curiosity with discipline and structure. Is a champion of value-add change and evolution and is able to inspire and motivate others.
Knowledge/ Experience and Skills:
Minimum 15 years of industry related experience within the pharmaceutical industry.
Minimum 10 years of leadership responsibilities required
Experience working within the pharmaceutical industry with functional leadership experience of a Biostatistics or Statistical business unit.
Experience supporting clinical portfolios spanning multiple therapeutic areas and development phases.
Line management experience with multi-functional organization.
Management of a budget, inclusive of resourcing and outsourcing and discretionary spend.
Regulatory in-person interaction, e.g. Scientific Advice, Advisory Committee, etc
Experience driving large, complex change efforts and to drive results through influence, persuasion and relationships
Assesses quickly with a track record of getting up to speed and adding immediate value to new situations
Exceptional ability to co-create and work collectively with various business leaders and other key stakeholders
Excellent oral and written communication skills, including the ability to organize, conceptually interpret and clearly communicate material developed collaboratively via the input of multiple parties; translate complexity into the actionable
Effective influencing and negotiation skills
Up to 15% travel is required based upon business needs.
Doctorate degree is required in Biostatistics or similar discipline.
Travel (approximately 15%)
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.