JOB DESCRIPTION. Our Values: Innovation, Balance, Collaboration, Respect, Compassion, Determination.

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1 JOB DESCRIPTION Cure SMA Position Profile Cure SMA leads the way to a world without spinal muscular atrophy, the number one genetic cause of death for infants. We fund and direct comprehensive research that drives breakthroughs in treatment and care, and we provide families the support they need for today. Our Values: Innovation, Balance, Collaboration, Respect, Compassion, Determination. TITLE: LOCATION: DEPT: REPORTS TO: PREPARED BY: Senior Manager of Clinical Affairs (or Associate Director) National Office or Remote Research Rosangel Cruz MS, Associate Director of Clinical Affairs Jill Jarecki and Rosangel Cruz Check applicable interactive boxes below: Exempt Non Exempt Full-Time Part-Time Regular Temporary PART I. Position Summary & Essential Functions - The position summary is a brief summary of the role; describes the purpose and/or overall goal of the job. Position Summary: 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. Revised October 2017 (v.4) 1

2 Essential Function/Responsibility with associated competencies: I. Managing 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 II. III. IV. 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 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. o 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. o 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 Revised October 2017 (v.4) 2

3 Prior knowledge of Spinal Muscular Atrophy, a plus PART II. Minimum Qualifications Indicate the minimum education, experience and skills needed to satisfactorily perform the responsibilities of the position. Minimum Education Required - Check one box: HS Diploma Associate Degree BA/BS Masters PhD/MD List preferred related field for degree: Bachelor s or master s degree in non-profit management, marketing, or a related business degree. MS in a scientific discipline with significant relevant work experience and demonstrated success in similar job capacity. If experience will be considered in lieu of a degree, list the level of experience/education that will be considered. Example: Some college plus 10 years of related experience will be accepted in lieu of a Bachelor s Degree. 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. List any Professional License/Certification Required (i.e., LMSW, LCSW; CPA; CFRE): NA Minimum Experience/Skills/Competencies Required (e.g., Time Management, Communication): 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. Excellent Communicator (written, verbal, presentations) Excellent time management skills 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) Problem solving Working knowledge of MS Office Ability to work collaboratively as team but also independently from a remote setting Technical/Other: 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 Knowledge of marketing principles/experience with marketing campaigns a plus Revised October 2017 (v.4) 3

4 PART III. Responsibility for Managing Resources Describe the extent to which the position is responsible for handling organizations funds, using financial or material resources, monitoring or managing a budget, or controlling resources. The position will require maintaining projects budgets established by the research department leadership. PART IV. Supervision/Management Check all boxes that apply. Works under direct supervision while planning own work and following established practices Guides the work of other employees Works under general supervision while planning own work with authority to exercise independent judgment with respect to matters of significance Provides direct supervision over a department or team consisting of two or more full-time employees Number supervised: Level(s) supervised (e.g., Coordinator, VP, Department Head): Provides high-level strategic direction to multiple departments and shapes and interprets policy Provides direct supervision over one or more volunteers Number supervised: Type supervised (e.g., interns, admin, committees) other: Insert organization chart if in staff supervisory role: PART VI. Problem-Solving and Decision-Making Indicate the extent to which the individual actually makes decisions and the impact if they make a mistake. Please indicate whether the problems likely to be encountered on the job are routine or complex. If complex (i.e., involved, unusual, complicated), give an example of the types of problems encountered, how they are likely to be resolved and the discretion and independent judgment required. 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 goals. Thus, the will need to be able to represent Cure SMA well and represent our positions to external groups. PART VII. Physical Demands/Work Environment - The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Requirements of Position: Work is generally sedentary in nature, but may require walking, standing for long periods of time, bending, or reaching. Work Environment: Remote work environment is possible, with periodic travel to national office Attendance at 1 week Annual Conference is required Attendance at various consortium and research meetings is required Work is generally performed within an office environment with standard office equipment available Revised October 2017 (v.4) 4

5 The above statements describe the position as it exists now. They are not intended to be an exhaustive list of all responsibilities, duties and skills required in this position. It may be redesigned or reorganized at management discretion at any time. Approvals: Supervisor Date Human Resources Date Revised October 2017 (v.4) 5