The Director, Clinical Research Dermatology will be responsible for preparing and getting approved the global development strategy leading to the successful approval of the Dermatology application in multiple countries. This position will collaborate with multiple individuals across the company, most notably in Clinical Operations, Regulatory Affairs, Discovery Research, Program Management, Pharmacovigilance and Medical Affairs to execute this strategy. This person will have the experience, flexibility and maturity to adapt his/her skills effectively in a variety of diverse tasks related to clinical development of the company's products, from generating strategy to every aspect of drug development, including developing protocols, medical monitoring, analyzing data, collaborating with external experts and Key Opinion Leaders in Dermatology, and interacting with Regulatory Agencies. The incumbent will be responsible for working closely with physicians treating Dermatology patients and with regulatory authorities to oversee the clinical strategy in Dermatology disease, including young patients.
- Participate in setting the drug development strategy for the Dermatology clinical program.
- Play a significant leadership role, as well as provide "hands on" work and work in collaboration with relevant team members and peers to ensure the highest level of execution for Dermatology clinical development programs.
- Develop, author and execute on clinical protocols working with key opinion leaders, Clinical Trial Investigation site physicians, internal and external scientific, pharmacology and regulatory teams.
- Work with Clinical Operations and clinical research organizations, to collaborate on trial site selection, training and ongoing oversight of the study.
- Act as Dermatology Program lead medical monitor, conduct site visits as needed, have detailed understanding of patient level data including safety data, and clinical endpoints, and including in stream data review during the study.
- Ensure that studies are performed with the highest quality by collaborating with Clinical QA, perform data review and analysis.
- Contribute and author abstracts, presentations (oral and written) of clinical data, authoring and editing of clinical study reports.
- Successfully interact with Dermatology clinical trial investigators, experts and other external
- Participate in preparation of regulatory documents (e.g. Investigator Brochures, CSRs, briefing documents) and participate in face-to-face meetings with the FDA.
- Collaborate on business development activities.
- Perform all responsibilities in compliance with company SOPs.
Skills and Requirements:
- Medical Doctor's (MD) degree and post residency training is required.
- Completion of a fellowship or residency in either paediatrics or internal medicine or dermatology related area (a total of 3 years in residency is desirable).
- Significant experience practicing medicine is a plus.
- A combination of credentials and personal attributes including medical training, reputation, clinical and industry drug development experience and integrity are necessary for success in this role.
- Highly relevant (strongly prefer rare and orphan disease experience) industry experience (minimum of three plus years for Director level role).
- A drug development professional with experience (if possible global) derived from a career in a major pharmaceutical company, or in a significant biotechnology or biopharmaceutical company environment (prefer a minimum of two years with the same company or organization); a mix of big pharmaceutical and small-mid size pharmaceutical is a plus.
- Experience on teams with early and late stage development products (Phase 3 to regulatory submission).
- Experience leading Medical Advisory Boards.
- Strong project management skills, business savvy and business development experience is desirable.
- Excellent oral and written communication skills.
- Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others.
- Ability to produce highest quality timely clinical development work product/document with limited direction under tight time constraints.
- Hands-on performer, ensuring strong execution of clinical trials and other drug development activities.
- Flexibility and adaptability, able to thrive in small biotechnology company environment.
- A superior work ethic and a strong personal desire for success. He or she must also possess a strong sense of personal and professional ethics.
- A good balance of confidence and humility
- Must be passionate about developing treatments for rare/orphan diseases
- 25-30% of working time, domestic and international
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong on +1 646 878 6308 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.