Medical Director leading clinical initiatives and supporting healthcare policies in UK insurance. Collaborating with industry leaders and managing healthcare practices to ensure quality care.
About the role
- Medical Director/Senior Director leading clinical development at Scholar Rock, focusing on late-stage product candidates. Ensuring robust scientific and medical leadership from proof-of-concept to marketing approval.
Responsibilities
- Deliver clinical development plan for pipeline products from Proof-of-Concept through marketing approval and lifecycle management
- Provide medical leadership for clinical development activities of assigned pipeline products
- Collaborate with other members of the development and preclinical research teams to contribute to building a collaborative culture and improving effectiveness of the development team
- Engage with external scientific and clinical trial experts, health authorities, and consultants, to develop scientifically robust development plans
- Provide strategic guidance and support to the late-stage development team, including hands-on authoring, of clinical development plans, study protocols, investigator brochures, regulatory documents, publications, etc.
- Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
- Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program.
- Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency
- Work within compliance to all applicable GCP/ ICH regulations
Requirements
- MD, MD/PhD, or equivalent
- Based in greater Boston with ability to be present regularly in the Cambridge, MA office
- Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written
- 5+ years of experience in the biopharmaceutical clinical development function, with 3+ years of clinical development leadership experience; neuromuscular or rare disease experience preferred but not required
- Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills
- Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics
- Understanding of the drug development process from pre-IND through BLA
- Experience interacting with health authorities in the US and EU
- In-depth knowledge of ICH-GCP and other application regulatory guidelines
- Ability to travel domestically and internationally (~15%)
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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