Director, Development Sciences

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as their Director of Development Sciences. This key role within the Clinical Development Group will involve providing scientific leadership and driving strategic decision-making. The successful candidate will possess strong critical thinking skills, attention to detail, and collaboration abilities. Responsibilities span various stages of clinical development (Phase 1-3) across specific therapeutic areas. The position requires a highly organized individual capable of managing multiple projects and communicating effectively with internal and external stakeholders.

Requirements

• Advanced degree in Life Sciences (MD, PhD, Pharm D, or MS) required
• 3+ years of experience in biopharmaceutical industry in clinical development or clinical science with a proven track record of driving for results
• Strong critical thinking skills, including ability to synthesize large body of information and make decisions based on robust available information
• Experience with clinical study design, clinical data interpretation and publications, and working knowledge of biostatistics and pharmacology
• Experience to build strong relationships with both internal stakeholders and external scientific and medical community
• Highly organized, results-oriented, with excellent interpersonal and communication skills, including ability to integrate diverse perspectives to drive timely decision-making
• Exceptional communication skills & extensive experience and excellent skills in developing powerpoint presentations
• Ability to travel domestically and internationally (~10%)

Responsibilities

• Provide scientific leadership, accountable for scientific and development evaluation of new clinical development opportunities in specific therapeutic areas
• Provide cross-functional clinical sciences support to internal stakeholders for portfolio decision-making and clinical development strategy/planning. This may include review and synthesis of scientific literature, clinical & competitive landscape analysis, and summaries of clinical development innovations
• Serve as key contributor to program level documents. Independently support the development of regulatory documents such as IND, MAA, BLA, and responses to health authorities
• Ensure currency with innovative development strategy and competitive approach in key disease areas of interest. Independently conceive and communicate program- and study-level strategies that are well-grounded in supporting literature
• Provide strategic scientific expertise to develop and oversee all aspects of clinical projects including design, start-up, execution, analysis, and reporting of clinical studies. Identify and apply advanced analysis strategies to ensure accuracy and deep understanding of scientific and clinical data
• Anticipate opportunities or challenges well in advance; can effectively gather insight from internal stakeholders and external consultants for depth of the issue and perspective
• Ensure strong representation of clinical sciences team at key governance bodies and teams (e.g., PRC, early program teams).  Articulately convey key considerations to an issue and creative ideas or solutions for leaders to consider
• Provide scientific and content support on a broad set of activities, including study advisory boards, development leadership meetings, board presentations, and R&D Day presentations
• Foster and maintain relationships with key external advisors and partners
• Ensure highly organized and accessible content management: e.g., literature related to new indications, innovative trial designs, relevant scientific data
• Provide clinical sciences support to clinical stage programs, including manual data review and authoring or reviewing study related documents (study concepts, clinical protocols and amendments, investigator brochures, statistical analysis plans, clinical study reports, and safety updates)
• Provide development support for business development activities

Preferred Qualifications

Therapeutic expertise: Neuromuscular disease strongly preferred