MEDICAL DIRECTOR/SENIOR MEDICAL DIRECTOR, ONCOLOGY

Clinical Research Cambridge, MA Emeryville, CA

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Description

Gritstone bio is a public, next-generation personalized cancer and infectious immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The company’s goal is to identify and deploy neoantigens for novel treatments of cancer and infectious diseases. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients.

Position Summary:

The primary role of the Director/Senior Director, Medical Research is to provide medical, clinical, and scientific leadership and expertise to oncology clinical development programs. This includes working closely with cross-functional teams in which he/she operates, collaborates, and liaises closely with, including clinical operations, biometrics, regulatory, clinical immunology, project management, quality, business development, etc. The Dr/Sr Dr will provide strategic and development input as well as integrate input from various disciplines to help create, maintain and support the execution of the global development plans that will support the organization’s global development objectives. In addition, the Dr/Sr Dr will drive the execution of clinical development plans and study protocols across projects from a medical perspective.

The SMD also assures medical consistency within a trial and across trials within a program, assessing issues related to protocol conduct and/or individual patient safety. Assess the overall safety information for studies and vaccines in conjunction with Pharmacovigilance. Pay special attention to serious adverse events, pregnancies, AESI’s (adverse events of special interest) and potential safety signals. Serve as a counterpart of vendor physicians to ensure alignment of clinical trial activities (including, but not limited to, scientific and medical issues as well as patient safety). The SMD also reviews and discusses relevant study plans, available results and clinical information supporting registration with Regulatory Authorities, Ministers of Health, Health Organizations and Advisory Boards. The SMD is the medical responsible for interactions with regulatory and public health agencies, governments, community leaders, supranational non-governmental organizations and key opinion leaders as required, facilitating the acceptance of our vaccine development studies leading ultimately to registration while collaborating closely with Gritstone’s stakeholders. The SMD will also aim to become a matter expert in the disease area of the programs covered.

Responsibilities:

  • Provide medical and clinical research input for early clinical drug candidates and support Target Product Profile development
  • Contribute to the clinical development strategy, including preparation of clinical development plans, and guide development of clinical protocols for Gritstone bio Oncology products
  • Oversee design and execution of clinical protocols in collaboration with Clinical Study Directors
  • Conduct of clinical research in accordance with Good Clinical Practices (GCP) and the standards of the International Conference on Harmonization (ICH)
  • Close and productive communication with clinical sites to ensure patient eligibility, treatment, and appropriate reporting of clinical data
  • Analyze, interpret, and communicate clinical study data
  • Responsible for the composition and review of clinical study reports, Investigational Drug Brochures, manuscripts, abstracts, General Investigational Plans, and other relevant documents
  • Identify risks and recommend potential mitigation strategies that can impact the successful execution of a clinical study
  • Responsible for analytical support of clinical trial data (safety and, efficacy, and biomarkers), including analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
  • Responsible for composing internal and external presentations for scientific meetings (eg, investigator meetings, advisory boards, data presentations)
  • Support, mentor, motivate, empower, develop and retain Clinical Development and Research staff on clinical oncology projects
  • Provide review of clinical development plans and strategic initiative (e.g., data interpretation, protocol review committees)
  • Accountable for the ethical integrity of clinical plans, adherence to the highest ethical standards of Clinical trial conduct and adherence to all ICH-GCP requirements concerning human subjects
  • The SMD ensures that all activities are compliant with all applicable local, regional, and global regulations and obligations as well as in line with Gritstone’s own Ethical Guidelines and Business Practices and be an advocate of Gritstone’s values and integrity, internally and externally.
These efforts will facilitate the efficient development and execution of clinical studies to support the development of groundbreaking, innovative treatment options for patients with cancer.

Minimum Education/Experience:
  • Advanced degree in a scientific discipline preferred; ideally MD, or equivalent (DO, MBBS, MBBCh). Oncology experience in early development is a plus.
  • 3+ years of relevant industry experience such as working for biotechnology or pharmaceutical company or CRO health-related consulting company in clinical development or clinical research group with knowledge of vaccines/drug development process, including conducting Phase 1 to 3 clinical studies and submission of Investigational New Drug Applications.
  • Understands and interprets complex scientific issues across projects as they relate to vaccine clinical development requirements and strategy.
  • Previous experience successfully executing a clinical development plan with responsibility for studies/activities in multiple regions.
  • Experience and demonstrated ability to manage highly trained medical, scientific, and technical professionals preferred
  • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
  • Strong proven collaborative skills in working with global teams and teams representing diverse disciplines.
  • The ability to proactively identify clinical development issues; offer creative solutions and strategies, including risk mitigation strategies.
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, global, matrix team
  • Diplomacy and positive influencing abilities across multinational business cultures
Travel Requirements:
  • Up to 30%, some international travel required. 
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

The well-being and safety of our employees is our top priority. Gritstone requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (fully remote or site-based).  Fully vaccinated is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.  If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

Gritstone bio anticipates that the annual base salary for this position could range between $210,000 - $345,000. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal position salary ranges, and market data. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Gritstone is a multistate employer and the salary offered will be market competitive. At Gritstone, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

Gritstone’s benefit package includes medical, dental, vision, life insurance, and paid parental leave. Employees are also eligible to enroll in the 401k plan, which includes a 4% company match with immediate vesting. Employees are eligible to enroll in benefits effective the first day of employment and the competitive Paid Time Off (PTO) begins accruing on the first day as well. The job offer also includes an equity grant and eligibility for annual refresh grants based on performance. Gritstone employees also benefit from an Employee Stock Purchase Plan (ESPP) and thirteen (13) designated paid holidays as well as two (2) personal days.

Gritstone bio is an Equal Opportunity employer, as such, recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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