Sr. Manager/Associate Director, Medical Affairs

What You'll Do 

As the Senior Manager/Associate Director, Medical Affairs, reporting into the Executive Director, Skeletal Dysplasia, you will play a key role in the execution of Medical Affairs activities across the skeletal dysplasia portfolio. This role will have primary responsibility for medical review and MLR submissions, scientific content development, advisory board and company-sponsored symposium execution, Medical Information support, support for exploratory analyses of existing data and data generation opportunities, and management of external agency deliverables. You will independently drive assigned workstreams from development through approval and execution, while partnering closely with Medical Directors and functional leads on scientific and strategic decisions. This is a hands-on, individual-contributor role for someone who combines strong scientific judgment with disciplined project execution and can move complex Medical Affairs deliverables forward with limited oversight. 

Responsibilities 

• Serve as a Medical Affairs reviewer for scientific and medical materials, ensuring scientific accuracy, appropriate interpretation of clinical data, consistency with source documentation, and alignment with approved scientific communications, and escalate questions of clinical interpretation or strategic positioning to the responsible Medical Director. 

• Initiate, submit, and independently manage Medical Affairs materials through the Medical, Legal, and Regulatory (MLR) review process, including submission preparation, reference documentation, incorporation of reviewer comments, version control, resubmission, and tracking through final approval. 

• Partner with the Medical Information lead to identify needs for new or updated response materials and review Medical Information letters for scientific accuracy, appropriate data interpretation, and consistency with current evidence. 

• Support development and revision of Medical Information content in collaboration with the Medical Information lead and relevant subject-matter experts. 

• Manage execution of Medical Affairs advisory boards, including advisor coordination, timelines, pre-read materials, meeting logistics, agency management, MLR review, and post-meeting deliverables, in partnership with Medical Operations and other internal teams. 

• Work closely with Medical Directors to support development of advisory board objectives, agendas, discussion questions, presentations, and scientific content. 

• Support development and execution of company-sponsored scientific symposia, working with Medical Directors, external faculty, and KOLs to develop presentations and scientific content and to coordinate faculty review, MLR submission, revisions, and finalization of materials. 

• Support Medical Directors and Clinical Development in exploring and conducting novel analyses of existing clinical trial, natural history, and real-world data (e.g., post hoc, subgroup, and descriptive analyses), including helping frame analysis questions, coordinating with Biostatistics and Data Management, and summarizing results for internal review and scientific communications. 

• Assist in identifying and evaluating data generation opportunities (e.g., investigator-initiated studies, registries, chart reviews, and real-world evidence collaborations) by supporting data gap assessments, preparing concept summaries, and coordinating cross-functional input, with prioritization and approval decisions remaining with Medical Affairs leadership. 

• Manage day-to-day relationships with Medical Affairs agencies and external vendors supporting assigned programs. Partner with Medical Operations to ensure contracts, statements of work, purchase orders, and required approvals are in place, then independently manage vendor timelines, deliverables, meetings, revisions, and execution. 

• Track project milestones, risks, dependencies, and budgets in partnership with Medical Operations and functional leads, and proactively identify and resolve executional issues. 

• Partner across Medical Affairs, Scientific Communications, Field Medical/MSL, Medical Information, Clinical Development, Regulatory, Legal, Medical Operations, and other functions to execute priority Medical Affairs initiatives. 

Where You’ll Work 

This is either a hybrid role requiring in-office collaboration 2-3x per week in our San Francisco Office, or a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office. 

Travel up to 50% is expected for scientific congresses, advisory boards, company-sponsored symposia, KOL engagements, and key internal meetings. 

Who You Are 

• PharmD, PhD, genetic counseling degree, NP/advanced practice degree, MS, or another relevant advanced scientific or healthcare degree. Candidates with an MS or similar degree should have 5 or more years of demonstrated pharmaceutical or biotechnology Medical Affairs experience. 

• Typically 3–5 years of pharmaceutical or biotechnology Medical Affairs experience, including hands-on experience with medical review and MLR submissions, scientific content development, and advisory board or symposium execution. Candidates with a PharmD or PhD may qualify with less industry experience if supported by a Medical Affairs fellowship or equivalent. 

• Strong project-management and organizational skills, with the ability to independently manage multiple complex workstreams and deadlines. 

• Strong scientific writing and communication skills with exceptional attention to detail. 

• Working knowledge of clinical trial data and basic biostatistical concepts, with the ability to help frame analysis questions, interpret outputs, and summarize findings accurately. 

• Able to distinguish between executional decisions that can be independently managed and scientific or strategic issues that require escalation 

• Experience in pediatric rare disease, genetics, skeletal dysplasia, or launch-stage Medical Affairs is preferred but not required. 

• Able to travel as needed and legally authorized to work in the United States.