Director, Scientific Affairs and Clinical Development
- Job Title
- Director, Scientific Affairs and Clinical Development
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity and commitment.” Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Director, Scientific Affairs and Clinical Development
The Director, Scientific Affairs and Clinical Development will be a key strategic role to bringing new products (personal care products, OTC drugs, and medical devices) to the marketplace. As a support to the corporate strategy, the Director of Scientific Affairs and Clinical Development will be responsible for the creation and implementation of product and ingredient evaluation controls and documentation for the production of new products. The position oversees, develops, plans, and generates Clinical, in vitro, in silico studies, and/or technical reviews which will ensure the efficacy and safety of Swiss-American products or Swiss-American contracted formulations. Position achieves productive internal and external partnerships on conducting various studies and safety reviews in support of company pipeline and customer products. Collaborates the review of claims methodology and data to meet various regional needs through the establishment of supportive evidence.
The position requires strong leadership capabilities and level of experience in the fields of scientific affairs, clinical development/operations, toxicology, regulatory and consumer efficacy/safety methodologies. Interfaces with senior-level peers for the evaluation and interpretation of generated clinical test data, as well as, data obtained from extensive and broad resources, ensuring proper efficacy (claims) and safety risk assessment. Projects range from routine to highly difficult and complex. The incumbent utilizes expertise and experience to select the most appropriate project direction and leads developed test plans to support these projects across various departments. These test plans can range from the use of industry-standard test protocols to state of the art and/or emerging methodologies.
This requires diverse experience and knowledge of the latest clinical, in vitro, in silico, methods in efficacy and toxicological methods. The position requires the utilization of industry and academic contacts to remain aware of competitive, novel and/or theoretical approaches to test methodologies and, if appropriate, apply that research to Swiss-American products. The position ensures that Swiss-American product development support is inclusive of the most progressive and reliable evidence in the industry; the Director will also develop the parameters to qualify the safety of products in development by Swiss-American and ensure the documentation and conformance to the Approval for Product Release or similar Regulatory standard developed for scientific platforms.
This position is under the direction of the VP, RID. The ideal candidate will have a self-directed work style and not be timid in seeking out information from outside sources and peers. At the same time, this is a highly collaborative work team and therefore, the individual must be able to work effectively as part of a team, sharing information and supporting others in their roles, as needed.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Graduate/Terminal degree in biochemistry, physiology, pathology, immunology, toxicology, pharmacology or other technical subject is required; PhD with post-doc preferred, Master’s degree will be considered.
- 10+ years of experience in the personal care/dermatology/cosmetics industry with physician/investigator engagement and clinical trial experience, consumer healthcare industries is highly preferred.
- Must exhibit an exceptional degree of ingenuity, creativity, and resourcefulness to apply and/or develop highly advanced technologies, scientific principles, theories, and concepts, while professionally developing subordinates to do the same.
- Identify and lead technical opportunities to fulfill expected regulatory and safety needs via established and/or new test methods and technology. Oversee and guide the development of test methods or “claims” and evaluations in conjunction with other departments, specific CROs, suppliers or testing facilities. Sponsor and conduct appropriate evaluations to substantiate the value of novel technology and disseminates information to make the technology accessible to coworkers for product development objectives.
- Development of product and ingredient safety reviews for Medical and Regulatory submissions through technical and regulatory reports/presentations. Establish laboratory investigations, test methods development, and technology evaluation for ingredients, formulations, and end-products.
- Lead and guide new research projects by working a defined area of technical responsibility, providing technical training, and serving as a role model of technical excellence. Increase and improve the base of proprietary knowledge available to the technical teams by the development of new principles and concepts.
- Facilitate the development and proper functioning of interdepartmental and intercorporate teams. Act as the recognized expert/lead of the key team attributes of commitment, cooperation, communication, and contribution.
- Serve as a consultant to top management in long-range Swiss-American planning concerning new or projected areas of technological research and product advancement.
- Must possess a strong understanding of how the skin functions (skin biology) and/or physical chemistry or cosmetic formulation and the relationship between skin and various dermatological product types.
- Must be able to provide solutions to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity.
- Expertise in general toxicology concepts, with applied knowledge in areas of skin/eye irritation, skin sensitization, genotoxicity, immunology, and phototoxicity.
- Expertise in methodologies used to assess the safety and efficacy of OTC, cosmetic and medical devices.
- Experience in searching scientific literature (Science Journals) and publications and knowledge of compliance requirements and ability to organize requisite data.
- Excellent oral and written communication skills are required in order to interact with various levels of personnel within and outside Swiss-American.
- Demonstrated skills in analyzing, reporting and documenting information with attention to detail to ensure no mistakes are made, and establishing corrective actions/learnings should mistakes occur.
- Excellent computer skills including Microsoft Office, Internet search ability, and database experience.
- Must be able to work independently and with a broad management style to create an inclusive, innovative, communicative and respectful culture with an appreciation for diversity.
- Ability to work collaboratively with several groups and proficient problem-solving skills.
- Well-organized while handling multiple projects simultaneously with the ability to work independently in a matrix environment.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.