Director, Medical Affairs Operations (US)

Location: Radnor (Remote US), PA, US The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania. Idorsia is committed to meet the changing needs of healthcare professionals, patients, and their families. The core of what we do is to bring creative solutions to the market based on our science and data.

Idorsia offers a comprehensive benefits package that includes fully paid health care, dental and vision coverage, group life insurance, disability benefits, Employee Assistance Program (EAP) and Fitness Reimbursement. We offer driver benefits to our field employees that drive on our behalf. We offer a 401(k) savings plan with immediate vesting, generous employer match and both traditional and Roth options. In addition, you may select voluntary benefits, including additional life insurance and legal services/ID theft protection, that best meet you/your family’s needs. Generous education reimbursement program and flexible summer hours are available. The Director, Medical Affairs Operations (US) will rely on their experience to demonstrate success as a US leader within Medical Affairs in the US region including medical operations, medical information & medical communications. This role is a critical stakeholder in the outcomes and success of a global medical affairs strategy and how it is applied to the US commercial operations. Responsibilities include: Leads the execution of the operating rhythm for US Medical Affairs (USMA), including key team meetings, onboarding procedures, and colleague training plans, ensuring effective implementation across the functional spectrum.

Foster robust medical governance and streamline the execution of medical plans, ensuring efficient operationalization for the US Affiliate.

In alignment with Global Medical Affairs, ensures top-tier capabilities within US Medical teams.

Authors, co-authors, and provides training on relevant SOPs, business processes, and policies within the USMA organization.

Collaborates with US Medical Directors to devise performance metrics, developing dashboards and reporting capabilities as needed.

Collaborates with Global Medical Affairs Operations to prepare for internal audits and inspections, ensuring proper follow-up on actions and implementation of CAPAs.

Partners with the US Medical Directors in the development of US Medical Affairs plans for the specific assets. Additionally, spearheads the operational strategy for executing tactical initiatives within US Medical Affairs in the US Market.

Oversees the evaluation process for medical education grant and sponsorship requests and leads the Idorsia Grants Review Committee review for all funding requests.

Works within the US Medical Affairs leadership team to foster robust communication and collaboration regarding investigator-sponsored studies.

Ensures that the US Medical Directors are fully supported in the operationalization of advisory boards, medical education events, and medical communication activities. This includes the selection and management of external agencies and partners that support US Medical initiatives.

Develops medical communications content in collaboration with key stakeholders, both globally and in the US.

Collaborates with global Medical Information to analyze and pull through critical data and information within the US

Collaborates cross-functionally within the US Commercial organization for the planning and execution of national conferences related to the therapeutic area.

Establishes and oversees a comprehensive process for capturing, cataloging, analyzing, and disseminating pivotal insights derived from initiatives. Drives process improvement across various USMA activities, including advisory boards, medical congresses, and related processes. Conducts continuous assessment of operational needs for Medical Directors and the Field Medical team, ensuring seamless integration of best practices between headquarters and field personnel.

Identifies and implements innovative projects, as well as anticipates future technology needs, while expanding the scope of associated projects.

Keeps abreast of Medical Affairs competitive and external best practices, trends, and industry benchmarking (KPIs, capabilities, training, etc.) Manages USMA Medical budget, spend tracking and project prioritization. Is responsible for ensuring timely contracting and meeting all financial spend targets. Qualifications: Bachelor’s degree required

10 years’ experience in the pharmaceutical industry required. This experience can and preferably will be focused in medical operations and include a combination of medical communications, field medical or medical information. Will consider candidates with a Master’s degree in a science field and 8 years of experience or a PhD in a science field/PharmD and 7 years of experience.

Demonstrated Project Management experience required

Budget management required

Grant coordination and sponsorships experience required.

Quality Systems (eg. Med Comms) experience required. Veeva preferred.

Contract administration preferred

Travel approx. 5%

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course. Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

Pay Transparency Legal Requirement: Salary Range $215,000 - $240,000