Director, Clinical Affairs \u0026 Scientific Operations
Alfasigma

The Director of Clinical Affairs and Scientific Operations is a pivotal member of the Medical Affairs organization driving the design and execution of studies across ALUSA’s portfolio, managing a team of clinical science liaison’s and delivering operational leadership across the Medical, Clinical and Scientific functions within the company under the direction of the VP of Medical Affairs and in close collaboration with cross functional stakeholders in legal, compliance, finance, marketing, sales, supply chain and innovation. This is a hybrid position with office hours in our Bedminster, NJ corporate headquarters.

Key Responsibilities:

Clinical Study Design and Execution (50%)

• Act as primary point of contact and lead for developing protocols, synopses and other deliverables required for the evaluation of clinical study concepts sponsored by ALUSA
• Evaluate potential data sources to evaluate scientific gaps relevant to ALUSA prioritizing secondary use of data where appropriate and proposing primary research where necessary
• Receive and review proposed investigator initiated study concepts from a scientific standpoint in coordination with cross-functional stakeholders as required
• Manage investigator and site contracting and payment processes in close coordination with legal and finance
• Provide scientific review of critical deliverables for the conduct of the study, e.g. ICF, CRF, etc.
• Develop and deliver materials required for study initiation in coordination with agency partners (e.g. investigator brochure, investigator training materials)
• Track and, as necessary, audit studies in accordance with the data quality and integrity standards required to achieve ALUSA compliance
• Coordinate status updates with relevant internal and external stakeholders as required (e.g. newsletters)

Clinical Science Liaison Management (30%)

• Set and track objectives for Clinical Science Liaisons on the team
• Engage in performance reviews, co-rides and coaching for team members throughout the year
• Serve as the internal representative for the Clinical Science Liaison team
• Review and collate insight reports appropriate for identified forums

Medical Operations (20%)

• Develop and manage processes, including in coordination with Legal and outside vendors, required for the compliant performance of work within the scope of the team
• Review of available systems and optimization efforts impacting the Medical organization
• Review of monthly accruals and budget management for the organization
• Management of the medical strategic plan tactics inventory and tracking against progress
• Management of the safety information and medical information reporting vendor relationship

Experience and Education Requirements:

• Advanced degree in a medical or related scientific field, with a preference for relevant terminal degrees (MD, Phd, PharmD, etc).
• At least ten years experience in a field medical role engaging in scientific exchange with HCPs
• At least ten years experience in the design and operationalization of fit for purpose study designs (e.g. observational studies, collaborative research etc)
• Demonstrated ability to engage in Medical Strategy planning preferred
• Strong decision-making, negotiation, analytical, and relationship-building skills.
• Proficient in MS Office, with strong PowerPoint presentation skills.

WHO WE ARE:

Alfasigma USA is the local affiliate of the Italian based pharmaceutical company, Alfasigma. Alfasigma is a leading Italian pharmaceutical company focused on prescription drugs, over-the counter (OTC) and nutraceutical products and has a presence in 90 countries.

Alfasigma USA’s main goals are to improve the health and quality of life of patients by finding solutions to treat specific patient populations, expand our existing portfolio and bring new products into the US market. We strive to be a strong healthy company in a strong healthy world.

Alfasigma USA is headquartered in Bedminster, NJ. with a manufacturing plant in Shreveport, LA., a remote mail order pharmacy call center and an established national salesforce.

Alfasigma USA, Inc. offers:

• Competitive base salary
• Comprehensive benefits package: Medical, Dental, 401K, Paid Time Off, and Tuition Reimbursement are some examples
• New hires are eligible for medical, dental and 401K on date of hire

Alfasigma USA, Inc. and its subsidiary, Brand Direct Health, L.L.C. (collectively the “Company”) is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, religious creed, religious observance, color, age, sex, sexual orientation, gender, gender identity, gender expression, genetic information, national origin, ancestry, marital status, medical condition as defined by state law (cancer and genetic characteristics), disability, military service, military and veteran status, pregnancy, childbirth and related medical conditions, or any other classification protected by federal, state, and local laws and ordinances. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please email Human Resources at applicant@alfasigma.com if you need assistance completing any forms or to otherwise participate in the application process.

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