Founded by National Academy of Science members Rod MacKinnon, M.D. (Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, Flex Pharma is a biopharmaceutical company dedicated to creating innovative, novel treatments for neuromuscular disorders, and has demonstrated human efficacy related to muscle cramping.
Most muscle cramps are not caused by dehydration, lactic acid, electrolyte imbalance, or muscle tightness. That is why popular remedies like sports drinks, bananas, magnesium tablets, and stretching are usually ineffective.
New research has shown that cramps and spasms do not originate in the muscle itself, but are caused instead by a neural mechanism: excessive firing of the motor neurons in the spinal cord that control muscle contraction.
Flex Pharma is developing products to address muscle cramps and spasms by halting repetitive firing of the motor neurons.
As a high energy, new company, we at Flex are always looking for world class talent. We have listed a number of current openings below, but are pleased for great folks with relevant experience to email us with potential interest in Flex.
The Vice President, Clinical Development will be a key member of FLEX’s management team, and will be critical to shaping FLEX’s strategic direction as well as participating in key operational decisions. The candidate will be responsible for leading FLEX’s clinical development function, including clinical research, drug safety, clinical operations, data management, and biostatistics, and will drive the company’s regulatory approval strategy, roadmap, and execution. The candidate will be a strong leader and a strategic thinker, with a hands-on, detailed approach, as well as an entrepreneurial mindset and good understanding of commercial implications of clinical development. With an advanced degree in a medical and/or scientific discipline, the candidate will bring a strong knowledge of drug development, including a track record of successfully bringing products to market.
Duties and Responsibilities
Lead strategy and execution of all Clinical Development efforts across multiple functions (clinical research, clinical pharmacology, clinical operations, data management, and statistics), comprising internal and external teams and advisors, utilizing a highly effective process to meet tight timelines, budget, and regulatory requirements
Act as a key member of FLEX’s management team, to provide input into overall company strategy and key day-to-day operational decisions
Drive FLEX’s regulatory strategy and roadmap based on strong scientific and clinical input, and fully align this with overall consumer and strategic priorities
Lead submissions and interactions with the FDA and other regulatory bodies
Integrate scientific rationale, regulatory requirements/risks, product development plan and commercial goals to build a solid strategic framework for the clinical development plan
Provide strategic leadership for programs that integrate the candidate’s extensive knowledge in basic and clinical science with input from the medical community
Leads the design of efficient and creative clinical research studies (methodology studies, biomarker studies, proof of mechanism/ concept studies, registration studies) through application of medical and clinical development knowledge
Ensures patient safety in studies through excellence in design and ongoing safety/medical monitoring during study conduct and follow-up, consulting additional medical experts as needed
Responsible for clinical study execution in a manner consistent with GCP
Responsible for preparation of clinical documents, including protocols, IBs, clinical study reports, and clinical components of regulatory responses, in collaboration with other R&D line functions
Drive relationships with key external vendors (CROs, regulatory consultants, etc.)
Incorporate input from and support Consumer Product Development, Corporate Strategy, and other divisions to ensure alignment of product vision and development
Motivate and engage colleagues in an understanding of disease and excitement in an indication and mechanism
Help build a highly-functional, lean, and efficient Clinical Research and Development organization from the ground up, including organizational roadmap, hiring/developing new team members, and shaping the organization’s culture around the world, including the assessment of new opportunities
Interact with key opinion leaders, and SAB
Ensure appropriate staffing levels are maintained and that all assigned employees receive timely and appropriate performance feedback and developmental opportunities
MD strongly preferred or PhD with deep experience overseeing clinical programs, with 10+ years relevant professional experience in clinical development of investigational new drugs
Extensive regulatory submission experience in US and Europe
Experience in neurology, neuroscience, and pain therapeutic areas, strongly preferred
Ability to effectively oversee and manage multiple internal line functions and direct reports as well as external vendors
Effective leader and mentor, with the ability to attract and develop similar high-quality individuals and build teams
Flexibility and adaptability to work in a dynamic, entrepreneurial setting
Interpersonal skills, and the ability to work with a high-profile SAB
Excellent organizational and management skills, with the ability to communicate effectively verbally and in writing
Experience leading multiple functions across cross-functional teams, including translational science, clinical pharmacology, clinical research, clinical operations, data management, and biostatistics
Ability to operate independently, with initiative, and good business judgment
Objective-driven, results oriented, with a solid sense of urgency
Personal characteristics of integrity, team work, can-do-attitude and personal excellence
Ability to travel
If you would like to be considered for a position at Flex Pharma, please submit your resume or CV to firstname.lastname@example.org.
We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.