Are you ready to work with a leading team of experts to help solve unmet medical needs for neurological and fibrotic diseases? Our client, an emerging stage biotech in Maryland, is looking for their next leader to join them as the Medical Director for the company.

The Medical Director will provide medical expertise and leadership during the design, implementation, conduct, interpretation and reporting of clinical trials.They will be responsible for medical direction, strategy and oversight of all clinical research activities and ensure the established protocols are implemented and protocol integrity is maintained.

If you’re ready to join a fast-moving company, led by passionate and highly experienced executives, this role is for you.The company completed its first Phase 1 trial in early 2019 and is about to start a second Phase 1 (for a different product) and start two Phase 2 trials (one in Parkinson’s and one in diabetes). They have a number of submissions underway in the US and EU. 2019 will include a Fast Track application, a pre-IND, an orphan drug application, as well an SPA, a new IND, and new protocols. By early 2020, they expect to have trials underway with multiple products in multiple indications at >50 sites worldwide.

Responsibilities

• The candidate will work closely with contract research organizations (CROs) to establish and execute the clinical development strategy for one or more compounds from lead development in discovery to Phase I-III clinical trials
• Responsible for the design and development of clinical study concepts. Reviews and finalizes clinical development plans & protocols
• Will serve as the internal medical expert for the review, presentation, and interpretation of clinical study results
• Provide medical and scientific input to clinical programs and advise the development of and review all documents required for the conduct of clinical trials

• Manage safety issues in clinical trials and ensure that the clinical trial is conducted according to the protocol guidelines and all applicable regulations.
• Provide direction and participate in the selection of study investigational sites and maintain relationships with investigators and key opinion leaders
• Participate in vendor selection and oversight of full service CROs and specialty services
• Leads and supervises the Clinical Operations team to produce high quality deliverables on schedule

Experience & Qualifications

• Must hold a current, active unrestricted license to practice medicine in Maryland
• Must be board certified / eligible by a specialty board approved by the American Board of Medical Specialties.
• Medical Director with a minimum of 5 years of clinical research experience with neurological and fibrotic diseases.
• Knowledge of clinical research experimental design, including fundamental understanding of statistical principles
• Knowledge of state and federal laws and FDA regulations governing the healthcare, Clinical Research and Pharmaceutical Drug Development industry needed.
• Ability to apply technical expertise and make sound decisions

Company

Our client is a well-funded, clinical stage, drug development company with an exciting portfolio of new drugs for a number of important indications. This position offers a ground-floor opportunity to join our growing development team. You will join a strong team of well-funded drug developers with a history of success in biotech. If you have experience with the regulatory submission and writing activities required to support early product development, please do apply (see details below). This can be a growth position for the right candidate. Candidates with a foundation in regulatory or medical writing and a desire to grow within the position are also encouraged to apply.

We offer a generous employment package including a market-competitive salary, stock options, and 401k, as well as, medical, dental, vision, and life insurance.