Space sciences director job description

Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.

Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.

By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:

Scholar Rock is seeking a Director of PV Sciences that is a creative, resourceful, and integrative thinker. The person in this role works closely with the Product Safety Lead and Head of Pharmacovigilance to provide PV sciences support and leadership for Scholar Rock developmental assets, specifically early-stage oncology and/or neuromuscular and cardiometabolic disorders. You will provide scientific/clinical expertise, strategic input, and support for pharmacovigilance deliverables, which include the creation and preparation of DSURs, Signal detection presentations, safety board support documentation, health authority briefing books, safety section of informed consent and study protocols safety sections of the investigator's brochures, and any other deliverables as needed. This is a unique opportunity for an enthusiastic and collaborative individual interested in contributing to the development of transformative products for patients with rare and oncologic diseases.

Position ResponsibilitiesLead support for safety evaluation and content for the product safety lead Support clinical development activities such as developing the Reference Safety Information, Safety Sections of the Informed Consent, study protocols, investigators brochure Prepare and review safety-related section(s) for clinical, regulatory, and scientific documents Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting Lead author and/or contributor to the preparation of aggregate safety reports Lead and/ or contribute to the creation and maintenance of Reference Safety InformationDemonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Scholar Rock SOPs and quality standards Keep abreast of new PV/safety regulations and guidance from the regulatory authorities Develop or contribute to development of PV department processes Contribute to developing Core Benefit Risk template, Development Risk Management Plans for Scholar Rock products Health Authority inspection participation as a subject matter expert as a PV scientist
Candidate RequirementsMSc or PhD or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g., oncology, metabolic diseases, rare diseases etc.) with demonstrated experience with the responsibilities, deliverables, and skills At least 5 years of drug safety and risk management experience within the pharmaceutical, biotech or CRO industry Clinical drug development (Early and/or Late Phase) Safety Surveillance exposure Experience in leading safety/scientific activities on MAA/BLA submissions Experience Developmental core safety information creation and updates Authoring of Periodic Reports (i.e., DSURs) Development of Reference Safety Information/Investigators Brochure, Patient Informed ConsentsAuthoring Developmental Risk Management Plans (working ‘from scratch') Exposure to Senior Safety Governance Board interactions Demonstrable Patient Safety and/or Clinical/ Drug/Biologic Development experience across a range of activities Strong working knowledge of PV regulations Good understanding of safety-related epidemiology preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionSalary:

This is a 100% Remote Role and can be located anywhere in the US

Who We Are

HeadSpin is a startup organization, and we are revolutionizing the way developers test, monitor and optimize their applications. The company is building a first-of-its-kind global mobile device cloud platform that allows apps to instantaneously run on real devices across global mobile carrier networks. HeadSpin provides powerful, actionable data which pinpoint any problems in the app and enable developers to fix these issues before launch. HeadSpin integrates seamlessly with your development workflow and requires no changes to your app. The HeadSpin mobile platform is now in 80 countries and 140 cities worldwide, supporting over several hundred cellular networks and over 2,000 mobile devices. Using HeadSpin’s service, developers can launch products with the confidence that their applications will work in all the conditions that their users will experience. HeadSpin is funded by Google Ventures, Nexus Venture Partners, ICONIC, Danhua Capital, and other blue-chip investors.

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About the Role :

In this role, you will lead a team responsible for designing, implementing, and deploying algorithms to surface actionable insights into the performance and utilization of best practices in customer applications. You will work with platform and data engineers to surface insights and key metrics to customers via APIs, downstream databases, interactive user interfaces, and other applications. You will become a content expert and be expected to suggest recommendations and influence decisions by effectively communicating results to cross-functional groups. You will contribute to tools and techniques needed to help scale the team and deliver an exceptional product.

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What You'll Do

• Lead a team of PhD-level Data Scientists to accomplish business objectives
• Provide guidance based on experience for models and algorithm development to automatically surface insights into application performance and best practices at scale.
• Own data features from ideation to production.
• Work directly with platform and data engineers to build distributed data applications.
• Help guide and prioritize development of tooling to enhance our capabilities.
• Actively contribute to the adoption and development of architecture best practices and new technologies.
• Help train and empower sales engineers and other technologists using the data platform to gain real-time insights into customer application performance.
• Relentlessly analyze and improve the performance of our systems.

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What You’ll Need:

• Bachelor’s Degree in Computer Science, Engineering, or related field. PhD strongly preferred.
• 3+ years demonstrated experience leading open-ended or research project teams.
• Strong Python programming skill set.
• Experience developing product features based on metrics, algorithms, and machine learning models.
• Ability to explain technical concepts in simple terms to business stakeholders.
• Experience with distributed web services and REST API servers.
• Ability to own data features from ideation to production.

At Centerstone's Research Institute (CRI), we conduct research to prevent and cure mental illness and addiction. We also work to translate research into meaningful clinical practices and implement research-based strategies in real-world settings, thereby reducing the research-to-practice gap. CRI's workforce is interdisciplinary and comprised of Physicians, Psychologists, Dissemination and Implementation Scientists, Counselor Educators, Program Evaluators, Social Workers, Public Health Advisors, Biostatisticians, Clinical Transformation Specialists, Design Thinking Experts, and others. We collaborate with Academic Medical Schools, Universities, Statewide Mental Health and Public Health Departments, and Veteran-Serving Institutions in much of our work. Centerstone's Research Institute is a company of Centerstone, the nation's largest nonprofit mental health company who provides community-based behavioral health care, substance-abuse treatment and intellectual and developmental disabilities services in Florida, Illinois, Indiana, Kentucky and Tennessee. If you think you're a good match to join Centerstone's Research Institute, please review the career opportunity below and submit your application. We look forward to hearing from you!
Job Description:
Summary of Position:
The Director of Evaluation Science will support the Vice President of Program Evaluation on initiatives to integrate program evaluation and evaluative thinking into all aspects of service delivery/model/pathway implementation. Beginning during the writing of grant proposals through the application of lessons learned from evaluation studies, the director will work to standardize the conduct of program evaluation studies at Centerstone's Research Institute. In addition, the incumbent will also be responsible for developing and implementing protocols, policies and processes to support increased productivity, effectiveness, and efficiency within the program evaluation department.

This position is a remote, work from home, opportunity.

Minimum Education Level:
Requires a PhD in evaluation or closely related research oriented field with knowledge of evaluation methodologies, design, planning, implementation, data analysis, and interpretation of findings

Minimum Experience:
Five years evaluation experience in behavioral health or other social science setting required Demonstrable history of successful grant writing for service program oriented federal funding opportunities (SAMHSA, ACF, HRSA, etc.). At a minimum, such experience must include leading the writing of the evaluation section of such grant applications Two years staff management experience required

Essential Duties and Responsibilities:
Lead the development and implementation of a department-wide evaluation framework Lead development of the evaluation sections of federal grant proposals in collaboration with the grant writing department. Train program evaluators on the grant writing development process and develop processes to ensure quality grant applications Work with Lead Evaluators during project start-up periods to develop and test theories of action and create plans that include goals, objectives, evaluations, and measurement systems Develop plans and establish procedures for maintaining high standards to ensure that services meet and/or exceed established customer and company expectations Conduct trainings on evaluation science and practice Provide oversight of scientific rigor Lead the development and coordination of dissemination strategies to ensure the lessons learned from program evaluations are utilized in program improvement initiative as well as the broader sharing of information to state, national, and international audiences Develop processes for monitoring the performance of program evaluation department staff through performance management systems Embed continuous learning and reflective practices in the organization that will enable staff to regularly review the progress of evaluation strategies, track trends, and make course corrections as needed Formulate and recommend operating procedures that guide the program evaluation department in maintaining and improving its competitive position and profitability Serve as supervisory evaluator on evaluation projects Provide supervision and guidance to entry-level and intermediate-level staff Lead development of analysis plans and conduct advanced analysis for evaluation projects across the program evaluation department, including state-funded grants, federal-funded grants, and commercialization projects Responsible for oversight and compliance with internal review boards (IRBs) by coordinating submission materials and documentation and maintaining consistent monitoring of renewal and expiration dates Utilize database programs, such as Microsoft Access and Excel, REDCap, Qualtrics and SPSS, as needed to develop, manage and analyze data from evaluation projects Represent Centerstone's Research Institute within the nonprofit evaluation and assessment community, including cultivation of relationships with professional organizations and evaluator preparation programs

The ideal candidate for this position possesses leadership skills, as well as a strong ability to problem solve, find efficiencies and develop systems that support the sustainability of Centerstone's Research Institute. Further, during the grant development process, the Director of Evaluation Science will use grant writing expertise and knowledge of evaluation principles to directly support the development of evaluations for Centerstone's grant funded programming.

Success in this position requires the ability to apply principles of logical and scientific thinking to define problems, collect data, establish facts, and draw valid conclusions; to interpret an extensive variety of data collected as well as the capacity to deal with several abstract and concrete variables associated with operational constraints, pilots, scaling and evolution of clinical models and pathways.

The Director of Evaluation Science supports the program evaluation department's mission, vision, and values by exhibiting the following behaviors: excellent communication skills, honesty, integrity, innovation, flexibility, respect, commitment to scientific rigor, collaboration, critical thinking, accountability, and ownership.

Time Type:
Full time

Centerstone has a COVID-19 vaccination policy and this position may require proof of COVID-19 vaccination to qualify. Centerstone's policy is enforced in compliance with applicable federal, state, and local law.

Centerstone is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, disability, sexual orientation, marital status, or protected veteran status.

At Centerstone, we use our values as a guide for what we do. Respect, Expertise, Integrity and Empowerment are at the heart of every interaction at Centerstone, and particularly rooted in our beliefs toward diversity and inclusion.

Our approach to diversity is simple-it's about embracing everyone. Together, we continue to develop an inclusive culture that encourages, supports and celebrates the diverse voices and experiences of our employees. It powers our innovation and connects us closer to each other, to our clients and the communities we serve. We strive to create a workplace that reflects the growing world around us, and where everyone feels empowered, safe and welcomed.