Medical Director - Immunology/Dermatology
Millipore Corporation

Job Info

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Work Location: Billerica, Massachusetts
Shift:
Department: HC-RD-NAC Clinical Lead Immunology
Recruiter: Rena Ann Peterson

This information is for internals only. Please do not share outside of the organization.

Serve as the medical director responsible for clinical trial(s), overseeing execution of clinical trial activities in assigned projects.

Manage a cross-functional development team to define clinical trial activities that best support the overall program strategy.

Oversee and lead the planning and management of clinical trials, including study design, trial management and interpretation of results from a medical perspective.

- Responsible for a cost-effective approach to development plan activities.

Serve as Medical Trial Director:

• Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials

• Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies

• Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents

• Manage, mentor and develop assigned staff, as appropriate

• Co-leadership of trial teams

• Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders

• Support the review, analysis and interpretation of study data

• Support communication of study results as assigned

• Stay up to date in the assigned therapeutic area and sub-area including oversight of significant new developments

• Contribute to the progress of the organization by providing input into assigned business process improvement workstreams and tasks

EDUCATION & LANGUAGES

• Medical Degree (mandatory)
• At least 2 years (associated medical director / medical director, respectively) experience in the pharmaceutical or biotechnology industry, including knowledge of regulatory requirements in clinical development
• Board certification or expertise in related Immunology/Dermatology field preferred but not mandatory.
• Able to communicate effectively in English
• Strong medical writing skills

PROFESSIONAL SKILLS & EXPERIENCE

• Requires substantial professional experience in Immunology/Dermatology including clinical trials
• Experience in design, set up, conduct and evaluation of clinical trials
• Experience working in a cross-functional multi-site team environment

PERSONAL SKILLS & COMPETENCIES

• Ability to work in an intense, fast paced, global work environment
• Pro-active, problem-solving, constructive attitude
• Strong oral and written communication skills, including presentations (posters, paper, seminars) to internal and external parties
• Ability to collaborate in a seamless fashion with project/program/functional teams both face to face and remotely
• Ability to process complex medical-scientific topics and translate them into clinical development scenarios
• Able to maintain familiarity with rapid progress in the field

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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