Therapeutic Strategy LeadApply Now

Category: Clinical Project Management
Location: Home-Based
Salary: TBD

Job Description:

RESPONSIBILITIES:
 Accountable and responsible for creating effective delivery strategies and solutions for large, complex, multi-service, multi-region studies or programs to include mega studies and portfolio management, addressing the specific needs and challenges of each customer and differentiate Company from its competitors. In partnership with Sales, Medical, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets.
 Act as champion for project centricity within the organization through enabling the project delivery team assigned to an awarded project to understand and implement the project strategy that was sold. Evaluate and recommend effective adjustments to strategy when any trends or triggers associated with progress indicate this is required.
 Actively support long term enterprise business growth through collaboration with Centers of Excellence and other stakeholders.
 Accountable for the creation and optimization of innovative and effective and compelling delivery strategies and solutions for large, complex, multi-service, multi-region studies or programs, including mega studies and portfolio management, that incorporate and leverage Company services and experience, are operationally feasible, and result in the award of new business.
 Collaborate with Sales to evaluate and manage new opportunities received from customers from receipt through to award decision. This may include, but is not limited to, stand alone programs and projects, requests for information (RFI), capabilities, early engagement, and partnering discussions.
 Work with key internal stakeholders to analyze information and data that enables development of efficient and feasible delivery solutions. This may include, but is not limited to, protocol feasibility and risk management, identification of target site and principal investigator profiles, optimal country and site distributions, site initiation and patient recruitment modeling, assessment and management of the competitive landscape.
 Development and review of the budget (labor and pass-through costs) associated with the proposed project strategy. The budget should be competitive and in line with the contribution margin targets and pricing strategy agreed with Sales, leadership, and other stakeholders.
 Define and communicate the project team profile and organizational structure that will enable operational managers to identify and assign team members that can meet the customer’s needs and successfully secure the project award.
 Guide and mentor assigned Project Leader through a comprehensive handover of the project strategy and facilitate their understanding so that they can confidently present the project strategy to the client and the internal stakeholders.
 Actively support Sales in the preparation and conduct of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys project strategy and critical win themes. Attend and present at customer meeting, or bid defense or partnership meetings, as required, (based on the strategy for selling the opportunity).
 Coordinate with Sales to complete follow up actions identified at bid defenses and customer/ partnership meetings.
 During project execution, evaluate the project strategy with the project team and adjust delivery strategy when project or program progress, trends, and milestones indicate intervention required.
 Lead and support development of a project delivery strategy and budget over a short or potentially extended period as part of an early engagement effort. This may be in support of a customer partnership model where new work is assigned to Company in advance and/or non-competitively. It may also be used to develop a relationship and win business from a customer where Company seeks to proactively establish a relationship and win new business.
 Actively support long term enterprise business growth through collaboration with Centers of Excellence and other stakeholders.


Job Requirements:

Qualifications

Bachelor's degree in life sciences or related field. Advanced degree preferred, with specialization in one or more therapeutic areas and 12 years global clinical research experience , including hands on operational delivery and/or drug development experience. Proven track record in operational delivery and/or drug development; or equivalent combination of education, training and experience.

 Remain up to date with knowledge and information that supports effectiveness as a TSL e.g. understanding Company ’ services, and product offerings, status and trends in assigned TA(s), innovations and advances in clinical trial methodology, and business intelligence.
 Broad protocol knowledge; therapeutic knowledge desired
 Strong understanding of other Company functions
 Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
 Experience working productively in a pressurized environment, balancing operational and strategic priorities and maintaining a positive outlook at work; handles criticism well and learns from it
 Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery
 Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
 In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
 Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering
 Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
 Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization.
 Innovative and strategic thinker.
 Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments.
 Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required.
 Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic knowledge and competitive landscape.
 Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers.
 Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
 May require extensive travel

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