This position performs key scientific and technical functions to support both current sales and new products. This is a multi-faceted role in that it is responsible for internal technical functions including, but not limited to, evaluation of scientific and clinical data , claims support, regulatory support, product discovery & formulation, patent development & defense, product quality control, and product training to sales & marketing teams as well as external technical functions including scientific & clinical inquiries from physicians & patients, clinical reviews by managed care or technical service provider organizations, case report development, clinical field sales rep support, KOL development, publishing, and presenting our scientific & clinical data at meetings.
The individual should be both analytical and creative from a scientific standpoint and be effective in writing technical papers for publishing and giving technical presentations to target audiences including key decision makers who impact our business as well as translating the science to nontechnical people such as sales & marketing teams or promotional partners. This position emphasizes the application of science to prescription products promoted to specialist physicians in rheumatology, pain management, orthopedics and OB/GYN and perhaps other specialties in the future as additional products re developed and marketed.. It involves successfully collaborating with other functional teams at both headquarter and field levels and others involved in project management.. This position is a core part of the Company’s management team, and reports to the Clinical Director.
Base Salary $75K (depending on experience) plus bonus.
Scientific Affairs (40%):
- Evaluate and develop the scientific and clinical bases and support for our products, labels and promotional claims. Involves detailed assimilation of biochemistry and understanding of disease processes using extensive literature review and consultation, as appropriate, with internal and external experts. Manager may be involved with design and conduct of scientific or clinical studies through contracted suppliers, academia, or community physician collaborators.
- Provide scientific and clinical explanations in response to thoughtleader, prescribing physician, field sales rep, pharmacist, and patient inquiries.
- Develop technical dossiers and presentations on each promoted product for use by drug compendia such as FirstDataBank, managed care organizations, industry professional organizations, and promotional partners. This often involves creative assimilation and synthesis of disparate data sets into a cohesive analysis or to form a solid basis for making a management decision.
- Network with national and regional key opinion leaders (KOLs) as well as high prescribers of our products in our physician specialties to gain prescriptions for Primus products and support field sales & marketing activities.
- Scientific and medical education to support the development of niche sources of business such as workers comp reimbursement for Limbrel or menopause advocacy group affinity pull through programs for Fosteum.
- On an annual basis, recommend departmental project plans and related budgets for the next year as a part of the Company’s business planning and budgeting process for approval by senior management.
- Manage external scientific and clinical relationships with consultants, service providers or vendors, product development partnerships, and regulatory or industry collaborations. For example, this position will manage the scientific and clinical collaboration supporting product development, clinical and scientific studies, and publishing with the University of Messina.
- Encourage investigator sponsored case studies and clinical studies using Company products whereby Primus provides product and limited support in exchange for access to the data and at least shared publication and editorial rights.
- Develop patents to protect Company products as well as provide patent analysis and technical support of in-licensed patents. Includes the development of generic defense strategies coupled with convincing drug compendia or FDA of the uniqueness of Primus product(s). Will require working closely with patent counsel and external scientific experts as well as making scientific judgments.
- In collaboration with others, support the development and management of new marketing and sales programs and business development initiatives where scientific or clinical participation is needed.
- Provide field clinical support as needed for Company sponsored clinical trials.
- Obtain industry, regulatory and competitive intelligence by performing regular literature searches related to disease states and proprietary active ingredients of key products and by being active in professional and industry associations.
Medical Education (30%):
- Train our sales management, sales trainers, and key headquarters staff on the scientific and clinical rationale, mechanisms of action, claims support, published studies, patient types and clinical applications of our products. Involves both “training the trainers” and training the reps who interact with physicians. Requires presentations, development of written materials, workshops, and observing others providing product explanations.
- Participate and make presentations in various marketing and sales meetings.
- Educate headquarters staff about new product opportunities and provide internal sales, marketing and business development colleagues with technical insights to support their areas and new growth opportunities.
- Interact with promotional partner companies to inform them of our technical product rationale and support sales, marketing, trade or managed care programs.
- Train physician speakers, whether local, regional or national, to represent our products in professional settings. Includes providing them with updated scientific and clinical data and presentations and instilling confidence in our products so they can present them enthusiastically to professional audiences.
- Lead and contribute to the peer-reviewed publishing of scientific and medical articles. Deliver presentations about Medical Foods and scientific and clinical findings. These are intended to support promotional claims, and ultimately enhance credibility.
- Make Company and product presentations to key managed care accounts including pharmacies and clinical or contracting customers or committees.
- Provide training to field sales reps and headquarters personnel about product categories, clinical practices, and competitive products. Involves regular communication and gaining feedback from national and regional sales managers as well as from sales reps.
- Handle individual physician, pharmacy, managed care or patient inquiries which are beyond basic questions handled by the Primus receptionist (serious clinical questions are forwarded to the Medical Director).
Product Development (20%)
- Assist in identifying new ingredient and product candidates, including extensive literature compilation and analysis to summarize metabolic rationale, biochemistry, mechanisms of action, and scientific/clinical support.
- Prepare scientific, clinical and other rationale to support claims and regulatory qualification of new products.
- Develop or revise package inserts for new and existing products.
- Develop or revise statements of dietary need for medical food products.
- Proactively troubleshoot and solve problems to develop the most efficacious, practical, protectable, and economic formulations as well as enable product supply.
- Determine, qualify and support, as appropriate, line extensions, new sources of raw materials, new indications and new claims.
- Lead the scientific development of new products.
- Assist in the clinical development of new products.
Regulatory & Quality Control (10%):
- Review regulatory classifications and status of products on a regular basis.
- Prepare any documentation to support the regulatory classification and related compliance.
- Report adverse events to FDA after clearing the reporting of all cases through the Clinical Director
- Respond to noncompliance issues or inquiries from regulatory authorities with close communication and concurrence from senior management.
- Collaborate with Manager/Trade activities to ensure proper classification and registrations of products.
- Review new sales aides, patient education and literature, and collateral materials for use by sales force and customers.
- Provide regulatory input to the sales rep marketing insights team (FIT Team) as needed.
- Monitor warning letters and compliance issues for competitor or pertinent products from third sources to inform Primus management and commercial teams of new guidelines and learning.
- Prepare or revise standard operating procedures for technical and regulatory functions as needed.
- Review weekly or bi-weekly quality checks of Primus products.
Knowledge Skills and Abilities:
- PhD in a natural science such as biochemistry, immunology or a related field, or a Pharm D.
- Alternatively, MD or DO with a prior biochemistry, pharmacology or molecular medicine background and some clinical experience
- Post-doc work is preferred but not required
- Minimum of 2 years in a pharmaceutical, biotechnology, or medical device technical support role such as, but not limited to, medical science liaison, technical brand, scientific affairs, product or claims development, or technical writing or publishing
- Past successful interactions or matrix management of commercial teams is required
- Past successful experience making scientific or clinical presentations to scientists or physicians and working knowledge of publishing function is required
- Experience in providing technical support (i.e., “selling”) to managed care and trade accounts is a plus
- Experience in retail pharmacy is a plus
- Experience in a regional or headquarters environment is a plus
- Demonstrated track record of functional leadership and expertise commensurate with work experience
- Demonstrated ability to distill complex scientific and clinical concepts and data into meaningful education for nontechnical people or physicians with limited amounts of time or scientific background to comprehend.
- Demonstrated ability to work independently
- Strong analytical and critical thinking capabilities
- Collaborate well with cross-functional areas
- Excellent verbal and written communication skills and be easily conversant in Excel & PowerPoint