Cure SMA is seeking a Senior Manager of Clinical Affairs to oversee, execute, and deliver key projects, of an Industry Collaboration for a Spinal Muscular Atrophy (SMA), focused on impacting clinical development, early diagnosis of SMA, and regulatory affairs in SMA. S/he will be responsible for maintaining working group processes, goals, timelines, and established budgets, and ensuring that stakeholders adhere to those objectives.
Reporting to the Associate Research Director of Clinical Affairs, the Senior Manager of Clinical Affairs will work closely with the Chief Science Officer, and key leadership at Cure SMA and the Industry Collaboration to facilitate the implementation of all projects within the collaboration. External relationships may include key leaders at FDA, the SMA Industry Collaboration (SMA-IC), professional organizations such as the American Academy of Pediatrics (AAP), American Academy of Neurology (AAN), legal experts, consultants, biopharma companies, and academic centers.
The SMA Industry Collaboration is a multi-faceted partnership that brings together pharmaceutical companies, Cure SMA, and other nonprofit organizations, to share information, ideas, and data. The SMA-IC works together to address scientific, clinical and regulatory topics that are critical to advancing drug development in SMA and will benefit the broader SMA community.
Essential Function/Responsibility with associated competencies:
Work with the Cure SMA Industry Collaboration lead and other Cure SMA teams (research, communication, policy, development, family support) and external partners to accomplish the strategic goals of the industry collaboration.
Manage the day-to-day activities of at least two topic groups in the industry collaboration focused on impacting regulatory affairs, clinical development, and education & awareness of SMA in order to achieve goals in a timely fashion.
Implement specific work streams for topic group(s) in order to ensure project success
Liaison with industry partners to ensure their commitment and participation, including on collaboration funding
Support Industry Consortium on SMA Clinical Development / Regulatory Issues
Engage regulatory authorities to deepen understanding of SMA and the perspectives of patients on what is clinically meaningful.
Help manage working groups in an industry consortium focused on, 1) FDA interactions; 2) Providing the voice of patient /patient experience to the drug development process, 3) Defining clinically meaningfulness for clinical trials, among others.
Advance patient, families and health professionals’ education to reduce diagnostic delay in SMA
Partner with AAP, AAN and other external organizations to reduce the diagnostic delay in SMA via, educational campaigns for parents and health care professionals, and leveraging existing educational platforms to promote early identification of Motor Delays and awareness of SMA, among others.
Help produce materials for SMA community about basic research, drug development, and clinical trials
Promote increased site readiness for SMA clinical trials at sites throughout the United States, to better meet the needs of trial sponsors and the SMA patient community in light of anticipated increases in the number of trials being conducted in the United States.
Develop toolkit and other resources to aid efforts to expand capacity at all, existing and new SMA clinical trial sites. 2) Expand capacity of existing and new clinical trial sites by surveying and developing a plan to ready sites based on findings.
Partner with clinical research staff at top academic institutions in the US accomplish expansion goals.
Other Duties and Responsibilities
Contribute to a positive team dynamic of high-energy collaboration, operational excellence and results focus
Educate self on SMA research landscape with focus on clinical drug development and regulatory concerns
Represent Cure SMA externally with our industry collaborators and key opinion leaders
Coordinate and attend the semi-annual SMA Industry Collaboration in person meetings
Lead monthly teleconference calls to update topic group participants on progress of activities
Participate and attend relevant scientific meetings
Assist the Associate Research Director as assigned
Prior knowledge of Spinal Muscular Atrophy, a plus
MS in a scientific discipline with significant relevant work experience and demonstrated success in similar job capacity.
Minimum of seven to ten years and must have experience in a SMA research setting, and / or preferably in an industry environment or with a similar non-profit organization.
Prior experience dealing with clinicians, clinical trials, and scientists who work in an industrial setting is required.
Demonstrated success in program implementation and management and process improvement
Strong organizational skills are a must and a keen attention to detail
Ability to work independently, take initiative, complete tasks to deadlines and support assigned staff in doing the same.
Able to prioritize, schedule, and monitor multiple projects
Education and Experience to engage with scientists and clinicians
Strong interpersonal skills to create and oversee highly functional, collaborative, and successful teams
Able to strategically work cross-functionally with a variety of stakeholders
Demonstrated ability to present complex information to management, team, external audiences (large and small)
Working knowledge of MS Office
Ability to work collaboratively as team but also independently from a remote setting
Working Knowledge of biology and scientific research processes required
Experience with clinical drug development process and regulatory issues required
Experience with Clinical Trials, phases I-III are a plus
The position will require maintaining projects budgets established by the research department leadership
Position will interact with Associate Research Director and Chief Scientific Officer to overcome major project hurdles as a team. Position will interact with industry collaborators, key opinion leaders, and external groups to achieve project Thus, the will need to be able to represent Cure SMA well and represent our positions to external groups.
Cure SMA is a 501 (c)(3) organization dedicated to the treatment and cure of spinal muscular atrophy (SMA), a disease that takes away a person's ability to walk, eat, or breathe. It is the number one genetic cause of death for infants.
Cure SMA is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications ...for a position. Under no circumstances will Cure SMA discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender, gender identity/expression, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.