Sr Medical Director/Global Medical Indication Lead - Rheumatology(Client
- Maryland
- Permanent
- Full-time
- Provide continuous strategic medical insight and planning for the indication during all the stages of development. Own the Clinical development plan. Participate in long range strategic planning as data emerge in the indication
- Line management of the Global Clinical Trial Physicians working on the indication : coach and set example for their roles ensuring high quality medical support for the study teams, identify high performers for potential other roles
- Real time oversight of the medical aspects of studies in the indication including the relevant communication to management as well as the different study teams
- Safeguard harmonisation across the studies so that communications to external stakeholders (e.g. questions of IRBs, RAs) are consistent and company efficiency is maintained in close collaboration with peers as well as management of the different functional groups.
- Lead indication medical ad boards as appropriate
- Help build and maintain a “best in class” group of development medical doctors
- Ensure compliance of all studies in the indication
- Medical Doctor or equivalent degree required. Board certification(s) are preferred
- Specialty education(e.g. residency/fellowship) required in rheumatology. This should be accompanied by patient treatment and/or research experience
- In-depth understanding of end to end (phase I to registration) drug development, based on proven experience of at least 3-5 years in the pharma/biotech industry.
- Excellent English, both written and spoken is a must, as well as ability to travel.
- Proven leadership, motivational and interpersonal skills in a global and intercultural environment, including leading through influence (without having direct reporting lines).
- Pro-active problem solver with negotiation skills
- Must provide clear vision, direction, and purpose to the different study teams, Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
- Strong communication skills to ensure that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,
- Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity
- Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data
- Work is performed in an office environment with exposure to electrical office equipment
- Occasional drives to site locations with occasional travel both domestic and international
- Frequently stationary for 6-8 hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Frequent mobility required
- Occasional crouching, stooping, bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
- Regular and consistent attendance
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount