Executive Medical Director/Senior Medical Director, Clinical Development
Vice President, Clinical Development
: Redwood City, CAClassification:
Reporting to the Vice President Clinical Development, the Medical Director, Clinical Development - will contribute to the development and execution of the clinical strategy and provide medical and scientific leadership and oversight for the Coherus clinical programs. This role works collaboratively with internal and external multi-disciplinary teams responsible for the design and implementation, monitoring, analysis, and reporting of studies within the oncology/ immuno-oncology, to ensure each program meets the patient needs and company’s standards. This is a high impact and visible role.
Key immediate opportunities include:
- Attending study team meetings with internal teams, CROs and other vendors and providing medical oversight and clinical development guidance.
- Continuing the clinical development activities of our products to best position successful submissions with regulatory agencies.
- Provide medical leadership and design input for all clinical programs.
- Author study concept sheet, protocol synopsis, Informed Consent Form (ICF), and sections of template documents
- Write medical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
- Medical monitoring support to clinical investigators and internal/external team members (e.g., address medical and eligibility questions related to clinical protocols, answer product candidate related questions).
- Oversee safety for clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation) in collaboration with the Drug Safety/Pharmacovigilance team and other external vendors.
- Review and interpret clinical trial data and assisting with preparation of periodic and final study reports.
- Collaborating with the medical affairs team and contribution to the development and review of scientific publications.
- Support preparation of regulatory documents (e.g., IND, BLA, and other regulatory communications).
- Patient focused with a deep passion for improving their lives with developing novel and biosimilar therapeutics.
- Motivated to work in a fast-paced high accountability, mid-size company environment as a “can do” and collegial professional who leads through influence and interpersonal skills.
- Capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
- Demonstrated ability to collaborate with multiple functions in a team environment.
- Strong written and oral communication skills.
Education and Experience Requirements:
- MD/DO or equivalent with at least 5-10 years of experience in the conduct of clinical trials. (Board certification is preferred but not required) at academic site, CRO or biotech setting
- Early drug development, drug safety, translational research, and clinical trials ops Clinical development experience with biosimilars or oncology agents is highly preferred but not required.
- Experience in medical monitoring, protocol writing, study execution, data cleaning, data analysis, and CSR writing.
- Experience with leading both early and late stage clinical trials and participation in regulatory filings, and product launches.
- Ability to work effectively across functions, particularly when interfacing with clinical operations, statisticians, pharmacovigilance, and regulatory affairs.
- Executive leadership skills to educate and influence stakeholders and to add value to strategic business planning and decision-making.
- Exceptional interpersonal, problem-solving, and written and verbal communication skills.
- Excellent organizational and project management skills.
- Excellent writing, organizational, and communication skills
- Outstanding clinical and business judgment required
- Proven ability to work in a cross-functional and collaborative environment
- Willingness and availability to travel
- Prior experience working in a small/emerging company is strongly preferred
- Ability to provide scientific and clinical expertise to a clinical development program and clinical strategies for a product to obtain regulatory approval
- Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
- Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials
- Must be science-and data-driven
- Must have a results-oriented work ethic and a positive, can-do attitude
- Must be willing and able to be "hands on" and willing to "roll-up sleeves" and delve into details
- Strong business acumen
- Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner
- Relocation to the Bay area required.
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.