Senior Director, Global Program Team Leader

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

About the Position

TrialSpark is seeking a Global Program Leader. This role will report directly to the VP of Program Management and will be responsible for overall management of a late stage asset in TrialSpark’s emerging portfolio. This person must have extensive drug development experience. They will be a key contributor to setting strategy and a critical leader in the planning, execution and monitoring of tactics and operations for the development of drug assets.

The Global Program Leader is an experienced and established leader with the ability to influence across multiple functions and levels within TrialSpark, who serves as the matrix leader with overall accountability for an asset from acquisition to end of life cycle.  He / she guides and directs the creation and execution of a comprehensive asset strategy and phase appropriate brand strategies for one or multiple asset(s).  This responsibility requires consideration and integration of all functional activities relevant to the successful development, registration, manufacture and commercialization of the asset throughout its lifecycle with specific emphasis on ensuring an integrated strategy across these elements.  Serving as the primary face of the asset at TrialSpark, the Global Program Leader works with governance, functional leaders, and other cross-functional groups and external development partners, to advance and optimize the value of the asset consistent with its prioritization in the overall portfolio. This role will require someone with broad exposure to all the activities involved in successfully developing and launching assets and brands (Development, Operations, Commercial, Market Access, Regulatory, Safety, Project Management, Medical Affairs, etc.  The role requires substantial cross-functional interaction and will draw upon past experiences that will provide the best outcomes for the progress, registration, reimbursement and life cycle of one or more assets or brands.  The position will require broad leadership skills with enterprise level thinking. 

Responsibilities

• Chairs a Program Development Team (PDT).  In this capacity, serves as the enterprise leader who is the project’s primary point of contact for senior management. 
• Has a broad vision for the asset and leads the effort to create, articulate and present an integrated cross-functional asset strategy for all aspects of product development, commercialization and lifecycle management and ensures timely, multidirectional and comprehensive interactions with executive leadership.
• Maintains primary responsibility for the ensuing deliverables, including a functionally aligned asset development plan.
• Reviews and analyzes emerging data objectively to drive teams toward recommendations that highlight opportunities, address potential risks and proactively provide appropriate mitigations. 
• Has a deep understanding of the role and value of each function on the team, to know how to solicit timely input.  Collaborates with PDT functions to ensure the program is appropriately resourced and stays within the allocated budget and champions requests for incremental resources when appropriate.  
• Works continually with supporting teams to ensure that executed plans are consistent with the Target Product Profile (TPP), asset strategy, tracking progress in conjunction with the Program Manager, with attention to committed timeline and budget.
• Ensures that the PDT continually validates the viability of the program from a scientific and commercial perspective.  Develops clear, prospective Go/No-Go decision points and serves as a champion for the program, using objectivity and judgment to analyze, interpret and present data to senior management.
• Strategic advisor to cross-functional sub-teams (e.g., Clinical, Regulatory, CMC, etc.).
• ·Establishes close ongoing ties with all team members and supporting teams, to ensure appropriate empowerment and delegation and maintaining aligned efforts.  Maintains a function-neutral position in prioritizing actions and making decisions, with an eye toward optimizing asset value in a timely and high-quality fashion.  Coaches and mentors team members as appropriate.
• Represents the asset at interactions with external parties (e.g., advisory boards, regulatory interactions) when these engagements require broad leadership representation agnostic of functional subject matter expertise.
• Stays abreast of professional information, industry trends and emerging technology through conferences, medical literature and other available training, to augment expertise in drug development and the pharmaceutical industry.  Works with team members to maintain a comprehensive and up-to-date understanding of the competitive environment in the field and to assess potential impact on ongoing programs.

About You 

• Bachelor’s Degree required; Advanced (Doctoral-level or MBA) degree highly preferred.
• Relevant experience (minimum of 5 years to 8 years; 10+ years preferred) as a leader in a pharmaceutical/biotech R&D, Regulatory or Operations setting; ideally across multiple functions or settings over time.
• Ideally experienced across drug development
• Individuals with who have had the experience of following a single asset and associated brands through many or all the phases of the development and commercialization of a single asset will be preferred but achieving as an aggregate of experience across multiple assets is also acceptable.
• Demonstrated ability to lead and elicit top performance from teams in a cross functional, highly matrixed pharmaceutical/biotech environment, preferably with global scope, in any discipline which involves a broad understanding of all phases of drug commercialization.
• Demonstrated ability to communicate with and influence senior executives
• Experience of how different elements (discovery, development, regulatory, commercial etc.) fit together in the drug commercialization lifecycle and has demonstrable ability to rapidly assimilate new knowledge of relevance to drug development and commercialization
• Deep expertise in the strategy and execution for commercialization of drugs including R&D, Regulatory, Commercial and /or Manufacturing
• Ability to objectively exercise judgment and create pragmatic solutions to address complex cross-functional problems and to be accountable for obtaining stakeholder 
• advice to make informed decisions, in order to move a program forward in the face of uncertainty or incomplete data.
• Understands what’s important, and focuses the team and stakeholders there as well. Asks the right question to provoke thinking.  Seeks all points of view in order to find the best path forward. 

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.