Director- Medical Affairs
Alfasigma

Alfasigma is seeking a Director of Medical Affairs with experience in pharmaceutical supplements or OTC who will be responsible for providing strategic input and oversight in the development, implementation, and life cycle management for marketed and pipeline products. Also responsible for the development of healthcare industry understanding of disease states, medical foods and key ingredients relevant to Alfasigma USA. This is a hybrid role, three days in our Bedminster NJ office and two days remote.

This individual requires leadership skills necessary to set the strategy, development, management and implementation of all medical and clinical activities for marketed products as well as for future products in the pipeline. The Medical Director has a matrix involvement with multiple internal stakeholders, including but not limited to Legal, Regulatory, and the Commercial organization.

Key Responsibilities:

• Serves as the core medical team leader for approved products and products in development
• Contributes to the development of new indications and line extensions for existing products
• Actively involved in the development of target product profiles and lifecycle management plans
• Actively manages and develops relationships with key opinion leaders and the scientific advisory board
• Attends scientific meetings, fosters and develops strong relationships with investigators
• Oversees the development and implementation of publication strategies
• Participates in the promotional review process as the medical reviewer and approver
• Oversees implementation and timely execution of independent sponsored studies as well as targeted research agreements
• Manages the external funding review and approval process for medical and product related grants, sponsorships, and charitable contributions
• Oversees the development and implementation of fair market value rates and payment guidelines for healthcare providers participating in speaker programs, scientific advisory boards, and key opinion leaders.
• Manages adverse event investigations and reporting
• Actively monitors the scientific field informing the business of important trends/events/trials/publications
• Facilitates and enables a positive team environment, interacting with multidisciplinary teams

Experience & Qualifications:

• Advanced scientific degree is required (PhD, PharmD and MD are preferred)
• 8+ years progressive Medical Affairs experience in the pharmaceutical supplement industry or OTC space is required
• Excellent understanding of the interdependencies of the various medical, regulatory and commercial disciplines is required
• Demonstrated ability to independently evaluate, interpret and present complex scientific data
• Strong working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities
• Proven ability to build productive relationships and teams internally and externally and the ability to develop high potential subordinates into leadership roles is critical
• Ability to facilitate and merge strong science into commercially viable products

Preferred Skills:

• Highly developed interpersonal skills
• Strong leadership and organizational skills
• Excellent oral and written communication skills
• Energetic, flexible, enthusiastic, self-motivated, thrives on challenge
• Able to work effectively with outside service providers
• Ability to work as a member of a cross functional team to accomplish goals
• Ability to maintain high level of ethical and compliancy standards
• Demonstrated ability to stay abreast of trends and new information in the profession

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:

• Comprehensive Compensation Package:
  • Competitive base salary, depends on experience
  • Annual bonus potential
• Comprehensive Benefits Package:
  • Medical, Dental, 401K, Paid Time Off, and Tuition Reimbursement (etc.) are some examples
  • New hires are eligible for medical and dental coverage 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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