Locus Biosciences is seeking an experienced, self-directed, hands-on, and entrepreneurial minded Director of Medical Affairs/Clinical Development. This individual will be overseeing medically related key internal drug development activities that are critical to the success of the company. They will work closely with company leadership in developing, actively managing and ensuring delivery of all medically related aspects of Locus’ Urinary Tract Infection program and potentially other projects in pre-clinical and clinical stages of development. They will work closely with our Translational Medicine and Discovery groups to ensure the development of cohesive product development strategies and tactical plan. This individual will play a key role in managing clinically related activities such as study design and protocol development, trial execution, and be involved in data analysis across all clinical programs.
Responsibilities will include:
Reports directly to the Chief Development Officer with responsibility for:
- Medical oversight of the Urinary Tract program as well as other key portfolio projects targeting Crohn’s Disease, Oncology targets and neurological disorders
- Development of robust clinical trial designs while considering global Medical, Regulatory, and Reimbursement considerations
- Study protocol development
- Supporting clinical trial conduct
- Oversight of medical safety for one or more programs
- Participating in the development pre-clinical, clinical and regulatory strategies across one or more assets
- Ensuring the effective delivery of key milestones and data supporting robust and timely decision-making across the Locus portfolio
- Effective reporting of study and project status and identification and resolution of key issues and risks
Managing Project activities:
- Develop and maintain study designs across an evolving drug development portfolio
- Establishing and maintaining relationships with key opinion and thought leaders in the disease states being pursued within the Locus portfolio
- Develop and maintain a clear vision for the projects that they are leading and ensure broad communication of key objectives and milestones across the organization
- Identify and develop plans to address and overcome program issues and risks
- Regular reporting to the Executive Team on project status and issues and risks. Effective problem-solving ability and communications skills are required to be successful.
- Provide operational oversight and direction to vendors and guide cross-functional staff in support of assigned project(s)
- Use scientific approach and data to facilitate decision-making related to assigned project(s)
- Communicate and interact with key leadership of the company as well as with the Board of Directors and Scientific Advisors as needed.
- Lead project team members towards completion of key deliverables.
- Seek out and develop key relationships with investigators and other KOL’s.
- Work as part of the management team to help prepare and participate in Scientific Advisory Board (SAB) and Board of Directors (BOD) meetings as well as Business Development activities.
- Help to advance an organizational structure which will include both internal and external resources that enable company growth and profitability.
Candidate must possess:
- A minimum of 5 years of drug development experience in a biotech or pharmaceutical company
- Experience in managing the conduct of clinical trials
- Science background and possess an MD or equivalent
- Experience in drug development Medical leadership roles
- Excellent communication, organizational and interpersonal skills
- Capable in preparing for, facilitating, and documenting cross-functional meetings
- Ability to multi-task effectively
- Ability to actively produce tangible work products that help deliver on key drug development milestones
- Experience in helping prepare for and managing clinical protocols and regulatory interactions/submissions (e.g. IND, NDA, BLA)
- Staff and vendor oversight experience
- Experience in management of global clinical trials
- Infectious Disease or Oncology experience
- Ability to assist in budget and contract management