Homebased Senior Medical Director - Rare Disease

Job Id: 6652

Position Title: Senior Medical Director

External Description:

Position Summary:

· Provides high-quality comprehensive and strategic medical support to the high-profile domestic and international clinical research programs of Precision for Medicine clients

· Serves as the key project physician and provides medical and scientific expertise in support of early and late phase programs rare diseases and other therapeutic areas as required

· Supports business development activities for existing and potential Precision for Medicine clients

Essential functions of the job include but are not limited to:

Clinical Project Physician / Medical Monitor Activities

· Develop, review, critique and revise study protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications

· Preparation and ongoing review of the Medical Monitoring Plan and materials for investigator meetings, DSMB etc. and staff training sessions

· Assume responsibility for medical and safety monitoring /oversight on assigned projects including real time review of medical scientific data, inclusion and exclusion criteria, protocol adherence, etc.

· Contribute medical insight to feasibility discussions relating to specific clinical trial project proposals

· Develop training modules and provides training in disease states across company

Business Development Support

· Work closely with senior leaders in Medical, Strategic Drug Development, and Business Development to support the clinical development consulting process including clinical development strategy planning and preparation of clinical development plans

· Support Business Development and Proposals teams by supporting RFP process:

o Prepares medical considerations sections for proposals

o Supports or participates in bid defense meetings

o Meets with clients as needed

· Write or edit scientific content of deliverables within budget and timelines.

· Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy

Medical Department Support

· Collaborate with Senior Vice President, Medical and other members of the Medical Department to suppose growth and development activities globally

· Help to identify and recruit department members

· Oversee, develop, and support direct and indirect reports as needed

Qualifications:

Minimum Required:

· MD, DO, MBBS, or equivalent medical qualifications

· 10+ years of experience in drug development

Other Required:

· Completion of an accredited US/Canadian medical residency program or international equivalent in internal medicine or pediatrics

· At least 10 years of experience in clinical research including directly applicable medical monitoring experience

· A commitment to ethical, GCP-compliant, and rational drug development

· Ability to rapidly become conversant in a wide range of therapeutic disease states as required to support bid proposals and development programs

· Intellectual curiosity and passion for innovative and effective drug development programs

· Availability for domestic and international travel including overnight stays

Preferred:

· Drug development experience in neurology, neuromuscular, metabolic, and other rare/orphan diseases

· Understanding of gene therapy and appropriate international regulations and guidance documents for innovative medicinal products (FDA, EMA, etc.)

· Familiarity/experience with scientific/medical landscape of major regulatory geographical regions

· Maintains current scientific and medical knowledge base

· Osteopathic Medicine

· Prior CRO experience

Skills & Competencies:

· Ability to deliver on commitments; understands the service culture

· Strategic thinker who can build strategic drug development solutions associated with novel development programs, study designs, and patient populations

· Cross-functional, integrative, scientific, collaborative mindset

· Strong interpersonal and communication skills

· Ability to work with small and large clients with a variety of in-house medical/scientific expertise

· Strong oral and visual and presentation skills

· Ability to work effectively in a fast-pacing team setting, with minimal supervision

· Proven efficiency and effectiveness in working remotely across time zones

Division: Precision For Medicine

Business Unit: Clinical Solutions

Office Based: Remote

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available:

City:

Country: United States

State:

Community / Marketing Title: Homebased Senior Medical Director - Rare Disease

City: Raleigh

State: North Carolina

Country: United States

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Location_formattedLocationLong: Raleigh - Work from Home, North Carolina US