Associate Director, Medical Information

Cytokinetics•South San Francisco, CA

5d•Onsite

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Associate Director, Medical Information will oversee a core medical function providing accurate, unbiased, balanced and timely response to unsolicited medical inquiries regarding Cytokinetics marketed and pipeline products from HCPs and consumers, clinical sites and managed care organizations, requests submitted by field Medical and Commercial teams, and MI inquiries escalated from affiliates. The Associate Director, Medical Information will be responsible for managing the operational and tactical execution of Cytokinetics’ Medical Information capabilities in US and partner with global/regional leads to develop global core content. They play a critical role in ensuring that medical content is scientifically balanced, evidence-based, current and fair-balanced, and meets the scientific needs of medical community to help inform clinical care, formulary access decisions and other strategies which can have significant impact on the appropriate use of Cytokinetics’ medicines.

Requirements

Advanced life science degree (PharmD, PhD or similar)
5 or more years of experience in medical writing, medical information/drug information, and/or relevant clinical experience, may include post-doctoral training (eg, PharmD fellowship, clinical residency with drug information component) in Medical Information, Medical Affairs, or comparable industry experience
Demonstrable medical writing ability and the ability to independently conduct literature searches, critically evaluate literature and summarize clinical and scientific data
Exhibits advanced knowledge of Medical Information processes as well as comprehensive understanding of other internal stakeholders, including experience with medical, regulatory, legal review processes
Strong knowledge of applicable regulatory guidelines and standards (FDA, PhRMA, EFPIA, etc.)
Excellent interpersonal, analytical, and communications (verbal and written) skills and keen attention to detail
Demonstrated strong project management experience, including excellent planning, organization and time management skills and the ability to support and prioritize multiple projects of high quality with minimal supervision
Advanced proficiency with computer and software applications (MS Word, PowerPoint) and Medical Information systems used for information requests and content management
Proficiency at searching multiple medical literature databases (Pubmed, Embase, etc.) and reference management software (EndNote)
On-site in South San Francisco preferred
Approximately 10%-20% travel anticipated

Responsibilities

Serve as product information expert and interface with internal and external Customers to provide concise, accurate, and non-promotional responses to medical information requests in a timely manner
Responsible for implementation of the Medical Information plan across Cytokinetics' product portfolio
Partner cross-functionally across Medical Affairs, Commercial, Pharmacovigilance, Regulatory, and Compliance to support strategic initiatives including launch readiness, lifecycle management, congress planning and field enablement
Deliver Medical Information training to internal teams (eg, field medical, sales) and contact center staff
Monitor and analyze inquiry trends, metrics, and insights to inform Medical Affairs strategies and resource development
Collaborate with internal teams to ensure appropriate staffing, training, and operational support of Medical booth at key scientific meetings
Lead the development, review, and maintenance of global core content, including database of standard response letters (SRLs), FAQs, and custom response documents for rapid and consistent dissemination of product data across multiple regions
Collaborate with US and European medical information stakeholders to ensure maximal global utility of medical information assets and support content translation, adaptation, development, and version control
Monitor the medical literature and interpret emerging scientific and clinical data to ensure that all Medical Information content is current, accurate, and balanced
Oversee the US Medical Information Contact Center and ensure timely, accurate, and compliant handling of inquiries
Conduct routine quality assurance reviews of contact center responses and implement corrective actions or retraining as needed
Ensure appropriate documentation and follow-up of safety-related inquiries in collaboration with Pharmacovigilance in line with regulatory requirements in all required regions
Drive continuous improvement by identifying gaps and opportunities in Medical Information operations, systems, and content
Contribute to the development and revision of cross-regional SOPs, work instructions, and operational guidelines
Track and manage Medical Information budgets, resources, and vendor relationships