There are no mistakes, only lessons; the only bad result is repeating a sub-optimal result for the same reasons a year later because we haven’t understood, acknowledged, or taken steps to improve our performance.
Growth mindset of continuous improvement, not a fixed mindset of having reached some optimal state of knowledge or performance.
We pride ourselves on ‘pulling rabbits out of the hat’ to provide practical, useful outcomes for clients. At the same time, we are not unbridled advocates for clients; we have a hard-earned reputation with the agency as solid, straight-shooting, data-driven, transparent friends of regulated product development of safe and effective products. Our ultimate responsibility is to patients and the integrity of the process of sound product development.
We take a broad, long view on the purpose behind our work and why clients retain us. A project to obtain a regulatory result is not an end, but a means, to help patients and create value for the sponsor. We are an extension of the sponsor’s management team, with expert knowledge of our subject matter, helping the sponsor to examine, improve, and realize its corporate development strategy.
No matter the effort put into a project, we want our work to be measured by the value it contributes to the client and therefore, we work and bill as if we are billing ourselves, and not be satisfied unless we as our own clients would be delighted with the quality, speed and cost of our work.
While the client is not ‘always right’, we recognize that it is their company and project. Within legal and ethical constraints, we will strive to achieve optimal results for our client, whether because of, or in spite of, their suboptimal decision making qua
We have a collaborative, team approach. We exercise humility to learn from diverse points of view and experiences of our colleagues.
While our consultants are knowledgeable and can handle many aspects of an engagement based on their experience and expertise, if, in the best interests of our client, we can bring in expert colleagues to efficiently advise on aspects of their expertise, we do so in an inclusive manner, always motivated by the best interests of the client.
Full time salaried employees at a big company, or a large law firm, may start the meter running and want to take full time to carefully review existing documentation.
There is a time and place for careful, methodical work, but typically, our smaller, more nimble clients want us to quickly get to the gist of the engagement, to efficiently review what we need to provide our advice.
When looking at an engagement, look for ways to add value by the half hour or the hour of billings, rather than by days or weeks of billings.
Coordinate often with the Kinexum Project Manager and the client so as not to exceed estimates and surprise them with material excess billed hours, unless this has been discussed and agreed.
We are motivated by a sense of urgency. One of the ways we want to consistently delight clients is by jumping on projects and workstreams and delivering quickly with quality. Speedqualitydoes not sacrifice quality for speed, but rather, engineers needless delays out, so our work can begin quickly and continue efficiently until delivery, ideally earlier than expected.
This notion comes from the late Leigh Thompson, M.D., Ph.D., former Lilly CSO, who used to stress that for a needed drug, every day of delay costs lives, and for a blockbuster drug, millions in revenues.
A common business meme shows a graphic of a triangle with Quality, Speed and Low Cost in the vertices, with a sign: “Pick any two” — We want to deliver on all three: lean speed/quality, experienced judgment, open communication and listening, and algorithms and processes can help.
We err on the side of regular and frequent alignment, clarification, and confirmation, even running the risk of redundancy, rather than assuming or hoping there is alignment or understanding with the client, or with colleagues.
We are not engaged, ultimately, to dispense philosophy or an exegesis, but rather, crisp, clear, accurate, practical/actionable/tractable advice. When we fall short, we will keep at it, to a commercially reasonable extent, to satisfy our own high standards as if we were our own client.
We value the community and support of our Kinexum colleagues.
Of course, we demand mutual professional respect and courtesy of one another; but we value and aspire to warm, supportive, personal, relational, not transactional interactions with one another and with our peers among clients, vendors, regulators and others.
Refrain from using confidential information for personal advantage or advantage of others, except when helping advance the interests of the client. This statement includes no insider trading or private company equivalent.
Duty of Integrity (no data or other fraud, doing the right thing).
Duty of care (competence).
Duty of loyalty to Kinexum and the Client, within bounds of law and ethics.
Honor the Kinexum brand and reputation with the FDA, other agencies, and third parties.
Non-discrimination, Diversity, Safety and Inclusion
Non-discrimination on basis of race, color, religion, sex, national origin, age, disability, marital status, gender or sexual preference
We believe diversity to be a source of strength, resilience and creativity
No harassment (sexual or otherwise), bullying or intimidating behavior.
We aspire to treat all with kindness, respect and courtesy
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