Medical Director/Senior Medical Director - Medical Affairs
Title: Medical Director/Senior Medical Director – Medical Affairs
Reports To: Senior Vice President, Medical Affairs
Location: Redwood City, CA
Coherus Biosciences is searching for a creative, resourceful, integrative thinker for an important role in the Medical Affairs team at Coherus. In this role the Medical Director will take the lead on study design and oversee the planning and execution of clinical trials aligned with the late-stage clinical development plan, investigator-initiated trials (IIT) in collaboration with KOLs and serve as medical expert presenter and educator for internal and external needs.
To be successful in this role, the individual must be self-motivated, able to work well with cross-functional teams and external collaborators, be able to influence decision-making, and be able to operate within pre-specified timelines. The individual is expected to possess outstanding communication skills (both verbal and written), a strong work ethic, and a high degree of professional integrity. The candidate will be expected to develop positive collaborations with contract research organizations, academic institutions, and nonprofit organizations.
Duties and Responsibilities:
- Overall responsible for the study design of clinical trials in late-stage clinical development on assigned programs, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, the interpretation of clinical data, and the preparation of final clinical study reports.
- Serves as the IIT program coordinator, working with internal and external stakeholders to execute IIT strategy plan.
- Providing medical science input to overall clinical study planning and execution according to Coherus medical strategy. Establishes excellent cross functional collaborations with other functions on study management teams to contribute to data analysis plans and takes the lead on the interpretation of clinical trial data.
- Responsible for providing or supervising medical monitoring activities for all human clinical trials. This includes supporting adverse event reporting and safety management. Contributes to the assessment of benefit/risk. Monitors adherence to protocols and assists in the investigation of protocol deviations.
- Develops positive and productive relationships with investigators and external organizations and experts to optimize study design and executions.
- Provides medical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents.
- Serves as medical expert presenter and educator for internal and external needs (advisory boards, promotional speaker training, investigator meetings, congress presentation, etc.)
- Provides medical expertise, participating in medical and cross-functional strategy meetings.
- The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient in that setting. Must excel in a multidisciplinary environment as an integral leader and provide medical science leadership within assigned teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential. Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.
- MD degree and 5+ years broad bio/pharmaceutical industry experience in drug development or equivalent.
- Knowledge of multiple therapeutic areas related to Coherus biosimilar development, as well as proficient experience in oncology and immuno-oncology. Internal medicine and oncology experience/training is preferred.
- Knowledge and understanding of the drug development process including technical, business, and regulatory issues.
- BLA experience strongly preferred
- Diplomacy and professionalism, working collaboratively with the company and leadership.
- Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Able to command respect from peers, capable of highly-independent work as well as being a team player and role model.
- Able to effectively interface with clinical operations, regulatory, and other disciplines.
- Excellent verbal and written skills, allowing for open and effective dialogue throughout the company.
- Proven ability to manage multiple projects, and proactively identify and resolve issues.
- Must be able to solicit information, persuade others and shape outcomes.
- Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.