Medical Affairs Director

Company Overview

Saol Therapeutics (pronounced “Sail”) is a specialty pharmaceutical company focused on providing therapies to patients with unmet medical needs. The company has a strategic emphasis on CNS Disorders and Rare Disease therapeutic areas. Our seasoned management team has a broad range of experience in commercialization, acquisition, licensing, formulation and product development. We are a dedicated group of professionals who have committed our life’s work to developing and bringing high-value, much-needed drugs to market. We are looking for highly-skilled individuals who are patient focused, passionate, ethical, team-oriented, and who want to help build a company that will make a difference in people’s lives.

Role Overview

The Medical Affairs Director will be responsible for Scientific and Clinical support of SL1009 as the FDA reviews the submitted NDA. Additionally, the individual will partner with the commercial team to collaboratively design and execute a medical marketing strategy  In this role the medical advisor:

• Will oversee the creation and management of Saol Therapeutics Medical Affairs Strategy
• Facilitate coordination with the clinical operations group to implement the agreed-upon studies (e.g. Phase IV, Registries and Investigator Initiated Studies). Responsibilities may include the management of Clinical Research Organizations (CROs).
• Owner of all medical publications, including abstracts, posters, and journal articles. Will be the lead contact for medical publication agencies.
• Responsible for the creation of Medical Managed Care messaging and presentations. Expected to work closely with Market Access Consultants on PBM, MCO, and State Medicaid presentations.
• Support medical information external vendors, providing reviews and feedback for the creation of professional response documents, FAQ's and SOPS, evaluating and disseminating literature, etc.
• Support brand/franchise as a clinical expert in interactions with external and internal experts (e.g. KOLs, Advisory Boards, and other consultant programs).
• Provide clinical support to brand/franchise teams relating to medical content of promotional, medical, and scientific materials.
• Serve as a medical expert in assessing the scientific and clinical merits of Business Development Candidates.
• Acts as the brand/franchise medical expert supporting the pharmacovigilance team, including review of annual safety reports and quarterly AE reviews
• Develop drug monographs, patient teaching aids, and claims database for the company's products.
• Supports the review of promotional materials (and others) by the medical/ legal/regulatory review team and supports compliance of brand/franchise.
• Partners with Compliance to assess speakers for the Company Speaker Bureau, including tiering, fair market value, and compliance with Saol Therapeutics SOPs

Qualifications

• Advanced Degree in Medicine or related field (i.e Pharmacy)
• 10 years of experience in pharmaceutical, biotech, or specialty pharma companies
• Strong knowledge of compliance/regulatory environment within the Pharmaceutical, Biotech, and Specialty space
• Strong and proven leadership and interpersonal skills
• Successful track record of building constructive relationships with all stakeholders and team members including management, peer-group, and cross-functional team members/reports
• Excellent oral and written communication skills
• Superb judgment and capable of solving complex problems and ability to apply sound judgment in making strategic recommendations and interacting with customers.
• Willingness and appetite to travel, mainly throughout the US but including periodic international travel

Successful Candidates Demonstrate Saol’s Values

• Trustworthy – We believe that the foundation of trust is truthfulness, transparency and fairness. These principles will be the basis for all our interactions.
• Focused on Patients – We will anchor our decisions with full consideration of their impact on our patients, believing that in doing what is right for them serves a higher purpose.
• Passionate – We enjoy working hard, but are not one-dimensional, being curious about the world around us and striving to be continuous learners who surround ourselves with others who inspire and challenge us.
• Nimble – We embrace new and promising opportunities while adjusting quickly and efficiently to the inevitability of change.
• Entrepreneurial – We create value through our focus on providing solutions, drive to deliver results, and our ability to work together in solving business challenges with integrity.

Compensation

Saol Therapeutics is prepared to offer a competitive salary, bonus, and equity, as well as career advancement opportunities when the NDA is approved.

Apply or Learn More

Call and/or email resume to: HR@saolrx.com