The mission of the Neurofibromatosis Therapeutic Acceleration Program (NTAP) is to identify and develop new therapies for Neurofibromatosis Type 1 associated tumors. NTAP currently partners with more than 40 academic, government and private organizations to conduct NF1 associated research. Please visit http:// www.n-tap.org
Specific duties & responsibilities:
Reporting to the Executive Director, the Program Director will be responsible for the development of new clinical scientific and clinical operational initiatives for NTAP, the review / critique of ongoing clinical research initiatives, overseeing data and data analysis in collaboration with data analysis partners such as Sage Bionetworks and facilitating clinical collaborations among the neurofibromatosis type 1 (NF1) clinical research community within and outside of NTAP.
Oversee contractor / awardee resources to ensure clinical trial success, and for ensuring that all team members comply with relevant regulations, guidance’s, directives and standards. Ensure operationalization and execution of clinical trials including; adherence to all regulations and guidelines, agreements and scope of work and change orders.
Represent NTAP externally, by preparing and delivering presentations about NTAP initiatives, assisting with scientific reports, building new scientific partnerships and working closely with NTAP’s key scientific partners. External collaborations could include things such as involvement in the non-disclosure agreement process with corporations and new partners.
Have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, the principles of translational medicine and how to work effectively within cross-functional teams ensuring their success. We are seeking a well-trained clinical scientist/clinician with an entrepreneurial spirit and strong leadership skills who is driven by science and the desire to develop novel therapies for patients.
Specific duties could include:
- Interact with investigators of clinical trials and thought leaders in the NTAP community to facilitate the design of clinical synopses and protocols.
- Research and assist in the selection of investigators for clinical studies.
- In collaboration with the clinical teams for a specific product candidate - design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Collaborate with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- May act as primary contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
- Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
- Participates in internal safety meetings, analyzes and reports potential safety events.
- Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
- Helps to write and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
- Proactively provide feedback on emerging clinical and competitive trends.
- Demonstrate thorough understanding of both clinical and commercial strategies and priorities.
- Coordinate and facilitate clinical trials by developing and maintaining excellent working relationships with study investigators.
- Steer NTAP sponsored clinical initiatives working closely with the team.
- Review and comment on milestone reports for clinical research projects within the NTAP portfolio.
- Provide clinical education support for customers.
Perform, as appropriate, relevant research activities which may include, but not be limited to:
- Targeted or comprehensive systematic literature reviews;
- Longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes;
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence;
- Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;
Minimum qualifications (mandatory):
Masters in health science field, Pharmd, or other relevant advanced degree in health science field, plus 10 years related experience.
Excellent communication skills, with ability to give effective presentations to large as well as small audiences. Ability to be able to confidently interface in a concordant manner with external partners including (but not limited to): key opinion leaders and subject matter experts (from academia, private industry, and public agencies), regulators, prominent members of the NF community, and lay persons.
PHD strongly preferred.
Special knowledge, skills, and abilities:
Experience with Biomarkers, knowledge of tissue banking, strong knowledge of clinical trials (protocol writing, set up, operationalization, data reporting, and regulatory processes)
Knowledge and/or experience in one or more of the following areas; neurology, neurooncology, oncology, dermatology, surgery
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Classified title: Program Director
Starting Salary Range: Salary is commensurate with experience
Employee group: Full-Time
Employee subgroup: Exempt
Schedule: Working 37.5 hours per week; Monday – Friday 8:30am-5pm
Location: Johns Hopkins East Baltimore Campus 600 N Wolfe Street
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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