Senior Manager, Clinical Operations
Based in San Diego, CA, Escient Pharmaceuticals is a clinical-stage biotech company strategically focused on unleashing the therapeutic potential of Mas-Related G-Protein Receptors (Mrgprs) for a broad range of therapeutic indications. Our diverse team at Escient shares a passion for discovering and developing therapies for unserved patients that will positively change the course of their health and well-being. In addition, we embrace a unique and highly sought-after culture of authenticity, open communication, transparency, integrity, mutual respect and freedom to brainstorm and share one’s thoughts and ideas at every level.
Escient is seeking a Senior Manager, Clinical Operations to lead the implementation and oversight of clinical studies to achieve project and corporate objectives. This position will work with other development team members, clinical research organizations (CROs), clinical sites and consultants to ensure the successful, cost effective and timely execution of clinical studies.
The successful candidate will be responsible for running the day-to-day management and oversight of the clinical study team to ensure successful clinical trial implementation and execution. The clinical study team is comprised of internal and external matrixed functions including CROs and other vendors and employees/consultants representing functions including but not limited to: clinical operations, biostatistics and programming, data management, clinical safety, clinical science, clinical pharmacology/bioanalytical and regulatory.
The ideal candidate is forward thinking and creative with high ethical standards, a team player with strong leadership skills who is able to work in a fast-paced environment with drug development professionals and able to respond to changing priorities in a thoughtful, creative manner
MAIN RESPONSIBILITIES include the following:
- Accountable for the day-to-day management and oversight of the clinical study team to ensure successful clinical trial implementation and execution. The clinical study team is comprised of internal and external matrixed functions, including CROs and other vendors and employees/consultants representing functions including but not limited to clinical operations, biostatistics and programming, data management, clinical safety, clinical science, clinical pharmacology/bioanalytical and regulatory.
- Develop and implement (with management and team support) the operational plans including effective selection of CROs and other vendors, negotiation of site/vendor terms, establishment of smooth project integration and ensuring timely and compliant implementation.
- Actively and effectively communicate within Clinical Development, progress, activities and results for assigned responsibilities. Escalate and resolve vendor issues as necessary. Communicate challenges along with risk mitigation options and/or solutions. Prepare and deliver status updates as needed.
- Forecast trial resource needs (external costs). Accountable for managing/tracking study budgets.
- Evaluate novel methods of implementation that may lead to accelerated and/or higher quality clinical trial implementation.
- Provide input into (and in some cases prepare) all clinical trial plans and documents (protocol, informed consent, study manuals, monitoring plans, data management plans, safety management plans, etc.).
- Ensure all clinical activities are delivered in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations
EDUCATION AND QUALIFICATIONS
- Bachelor's degree and 6 or more years’ experience in Clinical Operations roles with a minimum of two years as a manager or above with direct involvement in early phase human clinical trials
- Proven ability to effectively lead cross functional clinical project teams
- Prior experience with managing complex clinical studies with a keen understanding of all phases of clinical operations, including clinical trial design, study implementation/start-up activities, clinical research associates and site management, data management, and study close out. Direct involvement in early phase clinical trials and/or clinical trials ex-US is preferred.
- In-depth experience managing small and large CROs with a track record of successful completion of outsourced studies including time to completion and remaining within budget.
- Experience with evaluating CRO and vendor proposals, negotiating key terms (including budgets) and selecting/initiating these relationships
- Experience interacting with and building strong relationships with clinical sites
- Experience in review or writing of clinical protocols, study manuals, case report forms, and informed consent forms
- Ability to present technical and business aspects of projects
- Strong interpersonal skills with an ability to effectively communicate to people at all levels of an organization
- Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timelines.
- Current knowledge of GCP, ICH guidelines and FDA regulations as well as familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
This position will initially work remotely on a full-time basis, but it is anticipated that working onsite in the San Diego office for minimally two days per week will resume at some point in 2021. Candidates must be able to report to the San Diego office. Travel will be required to the extent necessary for oversight of vendors and clinical sites (anticipated 5 – 10%).
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly be required to use his/her hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. The employee will regularly be required to sit, stand, walk, talk and hear; use hands to handle or feel; see computer screens and read printouts; and reach with arms and hands. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.