Job Description
Summary:
The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. The Medical Director’s primary focus of work will be to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. This position also participates in the strategic planning and execution of critical development programs for a variety of clients in oncology or autoimmune disease (depending on client and/or program assignment), contributes to the development of Precision’s Medical team, and supports Business Development activities.
Main Duties and Responsibilities:
- Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
- Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings.
- Write or edit scientific content of deliverables within budget and timelines.
- Collaborate with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy.
- Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts).
- Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications.
- Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed.
- Serve as a medical resource for study sites, the project team and clients.
- Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
- Assume responsibility for medical and safety monitoring on assigned projects.
- Participate in feasibility discussions relating to specific project proposals.
- Develop training modules and provide training concentrating on disease states
- Participate in process improvement activities.
- Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally.
- And other job duties as assigned by the line manager
Minimum Education & Experience:
- MD, DO, MBBS, or equivalent medical qualifications
- 5+ years of clinical experience
- Completed an accredited medical residency program.
- Completed a fellowship or equivalent relevant to assigned programs (e.g., oncology and/or hematology; rheumatology; allergy & immunology; endocrinology; gastroenterology; nephrology; neurology; or other related subspecialty).
- 5+ years of experience in oncology or autoimmune disease clinical research (depending on client and/or program assignment).
- Demonstrated expertise across the lifecycle of oncology or autoimmune disease drug development, with ability to strategically analyze clinical trial protocols in the assigned therapeutic area.
- Availability for domestic and international travel including overnight stays (approximate 30% travel requirement).
Preferred Education & Experience (optional):
- Drug development experience in oncology or autoimmune diseases (depending on program needs).
- Board Certification in Oncology and/or Hematology, or in a relevant medical subspecialty aligned to assigned programs, or equivalent.
- Phase I and Phase II clinical trial experience in oncology or autoimmune disease.
- Prior CRO experience.
- Maintains current scientific and medical knowledge base.
Knowledge, Skills and 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.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills.
- Communicate both verbally and in written form in an acceptable manner.
- Conduct formal presentations to a wide variety of audiences including colleagues.
- Strong visual and presentation skills.
- Ability to work effectively in a fast-pacing team setting, with minimal supervision.
- Proven efficiency in working remotely
#LI-Remote
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$227,600—$341,400 USD
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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.
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 [email protected].
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