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Mineralys Therapeutics, Inc. · 3 weeks ago

Director, Medical Publications – Medical Affairs

United States

Full-time

Remote

Director/Executive

$225K/yr - $240K/yr

8+ years exp

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for hypertension and related comorbidities. The Director of Medical Publications will lead the strategic development and management of publication plans in support of therapeutic areas such as chronic kidney disease and sleep apnea, ensuring high scientific quality and compliance with industry standards.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

Own and lead the Scientific Publications Team meeting and workshops to drive the development of the strategic global publication plan (inclusive of clinical, PK/PD, HEOR, Biomarker, preclinical publications) for the assigned programs with the ability to lead and collaborate effectively across numerous and diverse internal and external stakeholders

Provide writing and editorial support for clinical and disease state abstracts, posters, manuscripts, and other publications, including conducting literature searches and preparing annotated summaries for internal teams

Ensure and communicate regular updates to relevant key stakeholders to facilitate ongoing functional and regional planning and inform dependencies

Ensure that all publication-related activities are conducted according to standards, SOPs, applicable working instructions and, industry standards and educate on these policies as necessary

Ensure high scientific quality, alignment with medical strategy and adherence to compliance/legal requirements

Manage 3rd-party vendors to ensure delivery of quality publications on time and on budget

Utilize and champion the use of AI and digital technologies to optimize publication workflows and processes, including applications in literature review, plain language summary creation, and innovative approaches to data synthesis and visualization

Create, review and oversee the publication budget and serve as a financial steward in the creation of the deliverables and in the use of external vendors

Ensure that vendors are properly trained to and comply with company standards, on SOPs, company systems and tools while managing all vendor partners to execute the tactical plan effectively and efficiently for their assigned publication projects

Lead special projects with team and Med Affairs depts (eg team onsite meeting agenda)

Ability to collaborate with external authors and journals for the planning, integration, and execution of all publication activities

Have deep subject matter expertise on innovative and compliant publication strategies, tactics and policies

Provide and lead high level strategic thinking for innovative strategies in developing and disseminating scientific and medical data, including the integration of AI-enabled tools and digital platforms to enhance publication planning, data dissemination, and stakeholder engagement

Exceptional scientific writing, storytelling, and communication skills

Strong organizational and project management capabilities; able to manage multiple priorities and operate independently and manage budget effectively

Demonstrates intellectual agility, problem-solving skills

Ability to manage external vendors and provide clear, concise direction

Excellent written and verbal communication skills, with the ability to understand and effectively communicate complex scientific and clinical data to internal and external stakeholders

Highly organized with a strong attention to detail, clarity, accuracy and conciseness

Manage budget, forecasting, and resource allocation plan by developing materials to track team expenditures

Contribute to the development and facilitate cross-functional discussions to identify gaps and opportunities to evolve the publication plan

Manage processes, and activities focusing on quality and timeliness with an eye for efficiency

Accurate and timely reporting of post-publications metrics, compliant maintenance of records

Qualification

Medical publications managementAIDigital technologiesPharmaceutical industry experienceBudget managementScientific writingClinical trial designPublication management softwareProject managementCollaboration skillsProblem-solving skillsCommunication skillsAttention to detail

Required

A higher education degree (M.D., Pharm.D., Ph.D.), or master's degree in biomedical discipline or equivalent with demonstrated experience in publication management

8-10+ years of pharmaceutical industry experience, at least half of which is in Medical Affairs

5-8+ years' experience in medical publications/communications, or other related areas within the biopharmaceutical industry, preferably within a matrix structure, in Medical Affairs or Clinical Development (e.g. clinical scientist, medical information, medical communications, medical information, publications)

Prior experience in hypertension, chronic kidney disease, and/or sleep apnea

Understanding of the pharmaceutical drug development process, clinical trial design and execution, statistical methods, and clinical trial data reporting requirements

Deep knowledge of scientific publication planning processes and industry standards for reporting scientific studies including but not limited to GPP, ICMJE, COPE, CONSORT, STROBE, PRISMA

Experience and knowledge of publication management software/systems

Ability to foster diversity of opinion and an environment of open communication and trust

Demonstrated ability in coordinating and implementing simultaneous projects within a complex matrix

Demonstrated ability to formalize governance structures and develop operational processes and SOPs

Experience in vendor and budget management