Senior Clinical Development Director
4 weeks ago
Coherus BioSciences is seeking a highly experienced Vice President of Oncology Clinical Development to lead our clinical development programs. The ideal candidate will have a strong background in oncology clinical development, with experience in managing clinical research staff and leading late-stage development and regulatory filings.
Key Responsibilities
- Provide medical leadership and oversight of Coherus Oncology clinical programs
- Continuing the clinical development activities of our oncology products
- Provide strategic leadership and design input for all Oncology clinical programs
- Write and review medical aspects of core study and regulatory documents
- Oversee medical monitoring support to clinical investigators and internal/external team members
- Oversee safety for clinical studies
- Review and interpret clinical trial data
- Contribute to the development and review of scientific publications
- Represent clinical research on internal program teams and external project teams
- Participate in discussions with regulatory authorities as appropriate
- Support Business Development activities as needed
Requirements
- M.D. required with 7 years of experience in a clinical research role in the biopharmaceutical industry
- Board certified Oncologist with oncology clinical experience and drug development experience
- Experience directly managing clinical research staff and will have proven track record in late-stage development and regulatory filing
- Experience with leading early and late-stage clinical trials, 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
- Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process
- Experienced in presenting to board members, investors, potential partners, and company staff
- 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 to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOLs/CROs) and represent the company in public (e.g., scientific conferences, partners)
- 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
- Experience with providing mentorship to direct reports and maintaining clear communication on performance to direct reports (preferred but not required)
Base Salary Range
$275,000 - $375,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
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