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Associate/Director of Clinical Development
This is a REMOTE position (work from home), or you may choose to work or relocate to our office in Lexington, Kentucky.
THE ROLE: The Associate Director/Director of Clinical Development is the internal and external face of NX Development Corp (NXDC) for the development of clinical trials for Gleolan (Aminolevulinic acid HCl) as a tumor visualization agent for patients with brain and other solid tumors.
The ideal candidate for this position will have extensive experience in designing, initiating, and executing clinical trials for oncologic indications, as well as extensive experience interacting with key opinion leaders and regulatory agencies. He/she will have direct responsibility and oversight for planning and initiating new development programs at NXDC, conducting Phase I-III clinical trials, and will work closely with cross-functional NXDC staff members.
This position reports to the Executive Vice President of Clinical and Medical Affairs and will work closely with the VP Scientific, Clinical and Medical Affairs.
MAJOR RESPONSIBILITIES INCLUDE:
• Leading the development of new clinical strategies for Gleolan supplemental indications and drive successful implementation of such strategies.
• Draft regulatory briefing documents and prepare for FDA meetings to discuss clinical development plans, working with internal stakeholders and consultants.
• Draft Phase I-III clinical development plans, write clinical trial protocol synopses and protocols, and lead discussions and revisions of study design with internal stakeholders and external experts and consultants.
• Act as the key contact for sites and investigators during study start-up and execution. • Liaise between the company and clinical investigators, develop credible relationships with opinion leaders.
• Participate in the medical review of clinical trial documentation and regulatory submissions.
• Evaluate scientific information and new ideas to assist in benchmarking current development projects and identifying new research and development opportunities.
This is a new position within the company and as such, the candidate will initially be a sole contributor. He/she will eventually develop a team of clinical research associates to help execute specific clinical development programs as needed.
REQUIRED SKILLS & EXPERIENCE:
• Minimum of 7 years of oncology or neuro-oncology clinical trial development experience in the pharmaceutical industry.
• Expert knowledge of clinical trial design and execution.
• Strong knowledge of basic and clinical cancer research and its application to surgical oncology. • Effective oral and written communication and presentation skills.
• Must have strong interpersonal skills.
• Travel required – up to 50% annually
PREFERRED SKILLS & EXPERIENCE:
• Clinical or research experience in oncologic surgery
• Clinical or research experience in fluorescence-guided surgery
• Experience in regulatory filings with the FDA EDUCATION:
• Minimum of an advanced degree (MD or Ph.D.) with 7+ years of clinical development experience in the pharmaceutical industry.
• Neurosurgery, Neuro-oncology or General Oncology clinical training and experience preferred.
TO BE THE BEST-FIT YOUR STRENGTHS MUST INCLUDE:
• Strong Communicator: You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Organized: You are an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Ability to work independently and among a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
• Problem-Solving Attitude: As an action-oriented self-starter, you are eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable: You establish and nurture highly effective relationships with colleagues and external stakeholders.
• Experience working within a risk-based, capitated environment in an in-hospital application for novel surgical procedures.
• Possess relevant and extensive clinical and regulatory experience in design and conduct of registration and post-market studies.
• Have experience equivalent to 7+ years within a progressive integrated environment as a clinical leader, including time spent as a surgeon in the field of CNS, gynecological or solid tumor surgery.
• Possess a strong understanding of medical management principals and experience with supporting data analytics focused on outcomes analysis and management.
• Preferably have prior experience in a decision-maker in a startup life science company or pharmaceutical industry.
• Thorough understanding of the role of healthcare regulators and compliance.
• Have experience in handling media / PR issues.
• Have a strong network of influential relationships with key healthcare surgical oncology stakeholders.
• Pragmatic business approach to problem-solving.
• Be a confident and engaging presenter to conference audiences as part of the NXDC team.
If you are interested in applying for this opportunity, please click here.
Medical Science Liaison
THIS POSITION REPORTS TO: EVP of CLINICAL, AND MEDICAL AFFAIRS
EXPECTATIONS FOR THE POSITION:
NX Development Corp. is a privately held financially sound life science company dedicated to the summarization of a recently approved first in field Fluorescence Guided Imaging Agent for the visualization of high-grade brain tumors. Reporting directly to the EVP of Clinical and Medical Affairs will help to ensure that NX Development Corp. meets or exceeds FDA regulations for Good Clinical Practice Standards and compliance related to Medical Affairs and Pharmacovigilance.
The employment venue is field based. The appropriate candidate will work remotely preferable US Central. This is a multi-functional role that will require organization and attention to detail across disciplines.
Travel domestically (70%) and internationally, as needed. ‘
COMPENSATION: Industry competitive relative to experience. Competitive benefits including health care, and matching 401K.
- Act as conduits of information about new research developments, clinical trial activities and therapeutic approaches to the use of Gleolan in surgical oncology.
- The job involves cultivating and maintaining relationships with academic researchers and leaders, attending conferences and talks, presenting information to international teams and introducing new therapeutic products to physicians and other healthcare professionals.
- Educate surgeons and allied health professionals in the new application of fluorescent guided surgery and train house staff on new applications.
- In-services for neurosurgery staff, OR, PACU, ICU, and other departments.
- Cross train to educate and support clinical trial sites when needed.
- Works interactively with disease experts, scientists and experts external to NXDC to identify relevant educational topics to be addressed.
- Keeps abreast of technical, scientific and medical information through attendance at selected Scientific Conferences, literature and other sources of relevant information and acts as a therapeutic area expert.
- Other duties as assigned by management.
Education: An advanced degree, such as a, MS/ Ph.D./ P.A. in a health care or clinical service is preferred. Research coordinators or RN (Registered Nurse); NP (oncology) or MSN (Master of Science in Nursing) degrees and with several years of experience (3-5 years) in oncology are sought. Previous experience as a Medical Science Liaison is preferred.
EXPERIENCE AND CORE COMPENTENCIES:
Prior experience as a Medical Science Liaison (3-5 years) and experience as a clinical educator essential.
- Must have superior interpersonal skills, including the ability to create and sustain relationships with industry leaders.
- Clinical trial experience either with sponsor or academics
- Product launch and/or prior marketing experience preferred.
- Exquisite problem solving with integration of medicine and science
- Competent in translating medical literature into teachable messages
- Strong organizational and project management skills with the ability to work independently and within a team.
- Capable of working in a matrix environment and playing nicely in the sandbox.
- Must be analytical and articulate in oral and written communications, with a demonstrated ability to communicate well with others at varying professional levels, especially in the medical profession.
- Must present and teach at conferences and hospital centers
- Ability to work with a sense of urgency, prioritize work, meet objectives/deadlines with strong organizational skills and attention to detail.
- Ability to adapt to a fast paced, ever changing work environment.
- Ability to travel extensively in the US – 70% travel.
- Must be able to clearly demonstrate a thorough understanding of the hospital surgical environment including all key external stakeholders.
- Must be able to demonstrate understanding of scientific/medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience required.
- Project management skills including meeting facilitation essential.
To apply for this opportunity, please email your cover letter and resume to our HR Department at: firstname.lastname@example.org
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