Senior Medical Director, Global Oncology Clinical Development
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POST DATE 8/25/2016
END DATE 11/19/2016
JOB DESCRIPTIONJOB TITLE: SENIOR MEDICAL DIRECTOR, GLOBAL ONCOLOGY CLINICAL DEVELOPMENT
PURPOSE OF THE ROLE
Indication Lead - oversees all medical aspects of a specific indication area of an oncology program or programs. Serves as lead clinical resource providing strategic and medical guidance to the indication team. Participate on an international product team to define and clinical development activities that best support the overall program strategy. Plan, guide and manage clinical trials, influence study design and interpret results. May define clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations.
KEY TASKS & RESPONSIBILITIES
* Serve as Clinical Indication Lead (CIL):
* Provide medical/scientific input and drive / contribute to the creation of relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
* Manage the clinical team supporting a specific indication. Roles could include both medical directors as well as clinical research scientists.
* Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility
* Oversees all medical scientific aspects of the indication and provides respective guidance to the indication /program team
* Oversees all aspects related to the scientific and medical risk in collaboration with the safety representative
* Supervise the review, analysis and interpretation of study data
* Support communication of study results as assigned
* Manage, mentor and develop assigned staff, as appropriate.
* Propose and drive clinical development strategies for assigned indication(s)/product(s) in order to establish its safety and efficacy and support registration in the shortest possible time worldwide
* Develop and prepare clinical development plans, study concept sheets, and study protocols in collaboration with clinical and project team members for assigned indication(s)/products
* Collaborate with Clinical Trial Management members in the selection of principal investigators and recruitment of clinical study sites
* Develop oncology biomarker strategies for assigned program(s).
* Coach early development teams.
* Partner with the External Innovation team on due diligence activities.
CANDIDATE S PROFILE
EDUCATION & LANGUAGES
* Medical Degree
* Board certification in Oncology, strongly preferred
* Able to communicate effectively in English
PROFESSIONAL SKILLS & EXPERIENCE
* Requires substantial professional experience
* 3 to 5+ years experience in industry ideally in a pharmaceutical or biotechnology company.
PERSONAL SKILLS & COMPETENCIES
* Ability to work in intense, fast paced, multinational work environment
* Strong oral and written communication skills, including presentations (posters, paper, seminars) to external parties
* Ability to collaborate in a seamless fashion with project/program/functional teams
* Able to maintain familiarity with progress in the field
EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
Equal Employment Opportunity
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, 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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.