An exceptional opportunity exists for a multi-talented VP, Clinical Development (an MD) to join a well- respected and growing biopharmaceutical company. In this unique role, you will have the opportunity and responsibility to be involved in a particularly wide range of critically important activities. This is a smaller company so it cannot be emphasized enough that this individual will need to have a passion for CNS. He/she will further need to have a willingness to do the hard work required in order to develop the drugs that can make a real difference in the lives of the patients who need them.

This is a truly different and unique opportunity...

Reporting directly to the Chief Medical Officer, this skilled VP, Clinical Development CNS will be a leader of multiple product teams. He/she will provide neuro-therapeutic and pharmacovigilance expertise and strategic thinking to the clinical development of neuro-therapeutic drugs and much more. The incumbent needs to have experience in developing epilepsy drugs.

The incumbent will manage the functions of: Medical Director, Statistics and Data Management, Clinical Pharmacology and Clinical Operations. He/she will also provide clinical operational support to each product team developing the pipeline.

• Must have MD or MD/PhD with a minimum of 15 years in commercial pharmaceutical company
• Ideally seeking someone with Board Certification in Neurology or Neuroscience field
• Must have a thorough knowledge of clinical research concepts and practices and a proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)
• Must have experience with NDA preparation and submission for a neuropsychiatric product
• Must have ability to engage with commercial on appropriate market development considerations
• Must demonstrate through experience strong ability to interact with FDA and other pertinent regulatory agencies during the developmental stage of neuropsychiatric products
• Experience in translational medicine, clinical pharmacology and early stage development is desirable
• Experience in interactions with FDA is essential; experience in interactions with other health authorities a plus
• Knowledge of relevant FDA regulations and guidelines
• Knowledge of the competitive environment for drugs in the CNS marketplace and in research and development pipelines

 
Additional skills needed

• Strong Leadership and experience in managing small to medium size teams
• Must be a self-starter, with a strong ability to establish networking relationships with various key medical opinion leaders (KOL's)
• This role will be a blend of not only Science, but Business as well
• Must be able to work effectively cross-functionally in a team setting
• Very strong verbal and written communication skills to represent the company externally in the scientific community. Writing skills will include clinical protocols so knowledge of basic clinical trial design and statistical concepts is important
• Ability to interact effectively with key industry regulators
• Strong ability to lead pharmacovigilance reviews and knowledge of global PV requirements

Must be willing, able and capable of contributing as following areas:

• Direct the development of clinical strategies and plans to integrate compounds into the standard practice of epilepsy
• Lead in the design and conduct of clinical trials
• Lead in the development of product development plans and clinical trial strategy
• Build, hire and manage clinical team(s)
• Lead project teams when required
• Provide operational oversight by collaborating with internal and external operations personnel
• Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
• Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
• Play leadership role in providing medical expertise regarding product development or other scientific issues for the clinical development team, drug discovery teams, business development and senior management
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities including development of IND's and clinical study reports
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Able to lead a various groups of clinical research professionals that at this time are in the area of operations, statistics and data management, clinical pharmacology and medical affairs
• Partner with other functions in preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOP's, pediatric investigation plans as well as abstracts and manuscripts
• Partner with other functions to interface with regulatory agencies for clinical development programs and regulatory submissions when necessary
• Lead the scientific interaction with relevant medical consultants/ advisors and investigators
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
• Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
• Represent company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners

Supervisory responsibilities may include the following...
• Medical Director
• Head of Statistics and Data Management
• Head of Clinical Pharmacology

Why consider this role...
This is an incredible company with amazing people and they are on the move.
They are committed to growing a pipeline of important drug candidates that have real potential to make a positive difference in patients' lives.
Enjoy the benefits of being in a smaller Biopharma while having the financial backing of an incredibly successful, global, multi-billion-dollar parent.

Excellent exposure and ability to be highly hands-on at a company that is dedicated to growth and strategic global expansion.

The Chief Medical Officer that this role will report to has an incredible wealth of diverse knowledge and experience. It would be hard not to learn from this highly talented individual.

Potential for professional growth opportunities. While there are no guarantees, this is a truly unique opportunity with a still small, yet growing Biopharmaceutical company.

Please note: The information above is not a complete job description or full list of all duties and/or responsibilities that may be required. It is simply an overview of this role. Also, please note that the job title and responsibilities are subject to change.