Associate Director – Medical Affairs, Publications

This is a fully remote position, open to applicants in California.

📋 Description

• Take ownership of the publications function for BHB-1893.

• Spearhead the strategy, planning, and execution of a multi-year publication and congress initiative.

• Oversee the publication process from initial concept to submission and final publication.

• Create and sustain the integrated strategic publication plan along with a publication concept backlog.

• Identify and prioritize opportunities in clinical, clinical pharmacology, nonclinical, mechanistic, HEOR, disease-state, review, and real-world evidence.

• Establish targeting strategies for journals and congresses.

• Direct the creation of abstracts, posters, oral presentations, and manuscripts for cardiovascular and HCM congresses.

• Manage submission timelines, deadlines, data readouts, and topline disclosures.

• Keep track of competitive readouts and the broader scientific landscape.

• Collaborate with Clinical Development, Biostatistics, Clinical Operations, Clinical Pharmacology, Regulatory, HEOR, Legal, Compliance, Commercial teams, and licensing partner Hengrui Pharma.

• Engage with investigators, members of steering committees, and external authors.

• Develop and maintain responsive scientific content such as slide decks, FAQs, and standard response documents.

• Establish the publications infrastructure, including SOPs, steering committees, workflows, and publication management systems.

• Ensure adherence to GPP, ICMJE, CONSORT guidelines, company policies, authorship standards, disclosures, transparency, and audit documentation.

• Oversee publication and medical writing agencies, managing budgets, timelines, and quality assurance.

• Track publication metrics and provide progress reports.

• Contribute to advisory boards, scientific training, and medical communications as needed.

• Report to the Head of Medical Affairs.

⛳️ Requirements

• An advanced scientific degree (MD, PhD, PharmD, or equivalent).

• For Associate Director: At least 5 years of experience in publications or scientific communications within biotech/pharma or a medical communications agency.

• For Director: Minimum of 8 years of experience, including leadership of publication strategy for a late-stage or launch asset.

• Demonstrated experience in strategic publication planning and execution across all stages of drug development.

• Comprehensive understanding of GPP, ICMJE, CONSORT, and related guidance.

• Knowledge of clinical trial design, statistical methods, and clinical data reporting.

• Experience in a matrixed, cross-functional environment with the ability to influence without direct authority.

• Excellent scientific writing, editing, and data interpretation skills.

• Proven experience managing external agencies, authors, and budgets.

• Strong organizational and project management capabilities.

• Capacity to work both independently and collaboratively in a fast-paced, resource-limited environment.

• Willingness to travel domestically and internationally approximately 15–20% of the time.

• E-Verify employment authorization confirmation required for new hires.

• Preferred: Background in cardiovascular medicine/HCM, CMPP certification, experience with late-breaking presentations and simultaneous publications, global publications with ex-US or licensing partners, expertise in publication function building, HEOR/RWE and clinical pharmacology publications, and familiarity with publication management platforms.

🏝️ Benefits

• Eligibility for annual bonuses.

• Equity eligibility.

• A comprehensive benefits package.

• Flexibility to work remotely or in a hybrid setting.

• A workplace focused on equal opportunity and inclusion.