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Medical Director - Dermatology

Parexel International Corporation

USA - Any Region - Home Based

Parexel is known for our unparalleled expertise in Dermatology!

Over the past five years Parexel has provided clinical research services for 101 dermatology studies, enrolling more than 27,565 patients at over more than 5,185 hospitals and clinics worldwide We play an integral role in bringing new treatment options to millions of patients globally! In fact, as one example, we played a key role in the research, development and approval of the first biologic treatment for patients with moderate to severe atopic dermatitis in 2017! The impact of our team is profound!

As a result, the team is expanding! We currently have an exceptional opportunity on our Medical and Sciences team for a Dermatologist to bring their experience to Parexel!

Responsibilities of a Medical Director include:

- Provide dermatology medical expertise to clients as contracted across multiple channels and interactions such as:

o Consultancy on protocol development, drug development program etc.

o Medical review of various documents which might be audited by clients and regulatory agencies

- Provide medical and safety monitoring for assigned dermatology projects. Medical support includes but is not limited to the following:

 Participate actively in study planning with feasibility leaders, solution consultants

 Participate in team project and investigator meetings

 Provide training of study teams on TA indication and protocol

 Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study.

 Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments

 Deliver medical monitoring activities according to MMP during the study conduct, including:

o Answer to site/ study team questions relating to the study conduct or protocol,

o Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.)

 Deliver medical leadership to the project in close coordination with the Project Leader according to the role assigned either GLP or RLP

 Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities

 Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD

 Provide risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director/ Global Head of Dermatology TA (as appropriate)

- Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity with billable tasks

- In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication

- Provide medical expertise/ leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings

- Attend preparation meeting and Bid pursuit meetings as required

- Provide support for marketing activities as requested.

- Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teamsQualifications- Medically qualified in an acknowledged medical school with completion of specialist training and certification in dermatology. US Board Certification in dermatology is strongly preferred; however, consideration will be given to exceptional candidates with equivalent certification and training in dermatology from other regions

- Clinical practice experience in dermatology

- Experience in Pharmaceutical Medicine, preferred

- A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred

- Good knowledge of the drug development process including drug safety, preferred

- Excellent interpersonal skills including the ability to interact well with sponsor/client counterpartsEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2020-10-28

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