Head of Medical Affairs

Remix Therapeutics•Watertown, MA

4d•$293,000 - $415,000•Onsite

About The Position

Remix is seeking a Head of Medical Affairs to provide medical affairs leadership for REM-422 and contribute to the development of future programs across the portfolio. REM-422 is an innovative investigational therapy targeting RNA splicing machinery, with adenoid cystic carcinoma (ACC), a rare salivary gland cancer, as its first clinical indication. With no approved therapy for ACC, this is an opportunity to help shape the medical and treatment landscape for patients with a rare cancer while playing a key role in advancing a novel therapeutic approach. Reporting directly to the Chief Medical Officer and based at our Watertown, MA headquarters, this individual will play a central role in disease education, scientific leadership, external engagement, evidence generation and trial execution, and interpretation of emerging clinical data. This is the first medical affairs hire at Remix. You will define what the function is, hire the people who follow you, and grow the organization as REM-422 moves toward approval and launch. You will also be the external scientific voice of the company, personally engaged in the field with KOLs and advocacy leaders. The role is global in scope; however, the United States is the initial focus and the first launch market.

Requirements

Advanced life science degree required. MD or equivalent medical degree preferred; PhD or PharmD considered.
10+ years in medical affairs and prior leadership of the function.
Oncology experience is required. Solid tumors strongly preferred; head and neck or salivary gland is a distinct advantage.
Built a Medical Affairs function from an early state rather than only running an established one.
Launch experience preferred, ideally with a first in class or first in disease product where the treatment pathway had to be established.
Existing relationships across oncology academic institutions.
Global perspective preferred, including working knowledge of the European medical affairs and regulatory environment or experience supporting ex-US capability.
Excellent written and verbal communication skills, including experience authoring or reviewing scientific and medical content for external audiences.
Demonstrated ability to operate effectively in a highly collaborative, cross-functional, and fast-paced biotechnology environment.

Responsibilities

Lead development and execution of Medical Strategy with a focus on REM-422 for use in ACC.
Build scientific awareness of ACC as a MYB driven disease across medical oncology, head and neck, and ENT communities, and establish Remix as a credible scientific voice in the field.
Work with other key stakeholders to map the ACC patient journey: where patients present, who they see, how they are referred, and where they fall out of the system.
Advance understanding of MYB biomarker testing so eligible patients can be identified, partnering with Clinical Development, Regulatory, and diagnostic partners.
Generate and codify real world insight on current management patterns and unmet need and feed it into development and launch planning.
Personally engage leading ACC, head and neck, and hematology investigators, and build the KOL network.
Oversee advisory boards, congress strategy, and scientific exchange that shape how ACC is defined and treated.
Build durable partnerships with ACC advocacy organizations and bring the patient's voice into development and launch decisions.
Represent Remix externally in scientific and business development settings.
Own publication strategy and execution across ACC and AML/HR-MDS.
Direct the HEOR, natural history, burden of disease, and real-world evidence to work that a disease with no approved therapy leaves undone.
Run the investigator sponsored trial program and provide medical insight into company sponsored trial design, endpoints, and lifecycle strategy.
Partner with Clinical Development, Regulatory, and Commercial on launch preparation, contributing to the medical and scientific perspective.
Ensure the clinical evidence base is accurately understood across the organization so that planning rests on what the data actually supports.
Provide an independent medical review of educational and promotional material and set the standard for scientific accuracy.
Coordinate field medical planning with commercial field planning, so coverage is complementary, and we act as one Remix team in all external interactions.
Inform market access strategy through the burden of disease and health economics evidence.
Design and stand-up field medical, medical information, and medical communications, making clear build versus outsource decisions and owning the budget.
Hire and lead a small, seasoned team that operates ahead of its headcount, and set the plan for how the function scales through approval and into launch.
Establish medical affairs policies, SOPs, and review processes consistent with the principles of scientific engagement, and partner with Legal and Compliance to keep all activity within Remix policy and applicable law.
Own the medical governance of expanded access and compassionate use requests, and the escalation pathway between medical information and Pharmacovigilance.