Sr Medical Director Oncology - REMOTE job in Brooklyn, USA

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Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Program Manager / Director, Clinical Scientist, Clinical Outsourcing

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Senior Medical Director Oncology with a mid-size oncology biotech company. In this role, you will be responsible for providing medical direction, management and review of clinical trials and product development.

Job Responsibility:

Applies biology and disease knowledge to clinical research trial development
Serves as Clinical Lead for pre-IND and clinical programs, working cross-functionally as both leader and content expert
Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub team functions
Drives preparation of clinical development plans in partnership with cross-functional team
Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
Contributes to CSR preparation and finalization
Contributes to development of CRFs and data review plans
Monitors, and reviews safety and efficacy data in ongoing studies
Serves as primary clinical point of contact (such as eligibility questions, AE management) for clinical trial sites
Develops clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
Develops and participates in advisory boards
Keeps abreast of hematology/oncology treatments, drug mechanism of action, approaches to drug development and regulatory requirements
Acts as a clinical representative in variety of cross-functional teams, including late-stage Research teams
Partners with Research, Translational/Biomarker and other Preclinical teams to help guide advancement of drug candidates with meaningful safety: efficacy profiles
Serves as clinical partner to Business Development to assist with potential partnering, other market/industry assessment activities and projects
Stays abreast of oncology treatment landscape and competitive intelligence

Skills and Requirements:

Medical degree required; hematology/oncology training and/or practice highly desired
Strong experience with many aspects of Drug Development and Clinical Research
Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies of small molecules
Experience and understanding of clinical trial data monitoring and all aspects of drug development
Knowledge of GCP and ICH guidelines is highly preferred
Leadership and Management experiences highly desirable
A proven self-starter and team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
Critical thinker with a solutions-oriented mindset
Self-motivated to work effectively in a dynamic environment
Possess strong organizational skills and conflict resolution abilities

If you are having difficulty in applying or if you have any questions, please contact Damian Albera at (+1) 646-367-2909 or d.albera@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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