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 Senior Director, Clinical Operations will be a key member of FLEX’s management team, and will provide critical input to FLEX’s strategic direction, as well taking responsibility for key operational decisions. The candidate will be responsible for leading FLEX’s clinical development function, including clinical research, drug safety monitoring, clinical operations, data management, and biostatistics, and will contribute to the company’s regulatory approval strategy, assuring compliance of the clinical development plan. 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 considerations that shape 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 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, contributing to overall company strategy and making key day-to-day operational decisions
Provide strong scientific and clinical input to FLEX’s regulatory strategy and roadmap, to assure alignment with overall consumer and strategic priorities
Author and review clinical submissions and lead clinical 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
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, statistical, 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 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
MS/PhD preferred 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
Passion for what we are doing at Flex; embraces and lives the Flex values
The Manager, Finance & Accounting will be responsible for various aspects of accounting, financial reporting, planning and analysis for the Company’s Drug Development, Consumer and corporate operations. Reporting to the Associate Director, Finance & Accounting, the Manager, Finance & Accounting will play a hands-on role in budgeting, forecasting and analysis as well as the monthly accounting close. This highly visible role will act as a key liaison with stakeholders across the Company and will have a high level of interaction with the Company’s senior management team.
In addition to the qualifications detailed below, the successful candidate will be a strong team-player who can thrive in a fast-paced, start-up environment and is eager to assist others, and go the extra mile as necessary, to help the Company achieve its goals and objectives. This position will be based in the Company’s headquarters located in Boston, MA.
Help establish effective processes to monitor and report on budget, actuals and forecast across the company’s Drug Development, Consumer Operations, and corporate segments
Manage the monthly forecasting process by partnering with department managers to align the forecast with the most current business assumptions
Assist with preparing budget and forecasts for management and board materials
Work side-by-side with department managers to establish the annual budget and long range plan
Provide expense forecasts and generate budget vs. actual reports, explanations of variances, and forecasted expenses
Prepare various profitability analyses and other ad hoc reports for the Company’s revenue generating consumer product, HOTSHOT
Collaborate with department managers and other members of the Finance department to ensure proper expense recognition in the Company’s financial statements as part of the monthly accounting close
Lead monthly operating reviews with department managers and management team, highlighting key cost drivers and risks/opportunities
Assist with preparation of financial presentations and supporting materials related to senior management and executive financial reviews, summary of quarterly results, board documents, and other initiatives
Perform analysis and provide direction to ensure well informed investment and operating decisions
Support the month end/quarter-end close process, including creation and review of journal entries, balance sheet reconciliations, and variance analysis for selected functions
Collaborate with other Finance and Accounting team members on ad-hoc projects, as requested
Bachelor’s degree in Accounting required
Public accounting experience preferred (combination of public accounting and private industry experience a plus)
MSA and CPA certification preferred
At least 6 years of combined accounting and finance experience
Effective oral and written communication skills, including the ability to convey ideas on complex issues, to make formal and informal presentations to management, and communicate effectively with inside and outside parties
Proficient in using ERP systems (Great Plains preferred)
Strong analytical and problem-solving skills, and ability to work independently and meet required deadlines
High attention to detail while also being able to view ‘big picture’
Excellent time management skills, with the ability to handle many priorities simultaneously
Extremely collaborative with strong interpersonal skills
Passion for what we are doing at Flex; embraces and lives the Flex values
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 and proprietary treatments for muscle cramps and spasms.
The Company’s Drug Development Division is developing targeted medicines to specifically treat cramping and spasms prevalent in severe neurological diseases such as amyotrophic lateral sclerosis (ALS) / motor neuron disease, Charcot-Marie-Tooth (CMT), multiple sclerosis (MS), Parkinson’s, cerebral palsy, spinal cord spasticity and numerous others. The Company’s Consumer Division recently launched a breakthrough product designed to help endurance athletes improve and maximize performance. Invented by Rod MacKinnon, a Nobel Prize-winning neuroscientist/endurance athlete, HOTSHOT™ is the sports shot with a kick that is scientifically proven to prevent and treat muscle cramps. A scientific breakthrough in sports nutrition, HOTSHOT is a proprietary formulation of organic ingredients that boosts Neuro Muscular Performance – how an athlete’s nerves and muscles work together in an optimal way.
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.