Title: Senior Medical Director, CNS
Manager: Vice President, Head of CNS Therapeutics
Department: Clinical Sciences
Location: Brisbane, CA or Remote
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today's medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let's build a better future together.
The Senior Medical Director will be instrumental in supporting the growth of Sangamo's pipeline. The person will provide translational medicine expertise as well as hands-on responsibility designing clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of assigned therapeutic assets. The role involves drug development across multiple disease areas. The individual will provide clinical leadership to multi-disciplinary, cross-functional teams through complex decisions integrating translational, medical, scientific and regulatory perspectives. This individual should have an interest and passion for work in all aspects of clinical drug development.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Conceptualize and optimize all scientific aspects of clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical team
- Serve as medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team
- Serve as primary medical contact for two or more ongoing trials providing appropriate clinical guidance to both internal (e.g. Clinical Operations) and external (CRO and other related vendors) stakeholders to ensure program objectives are met in accordance with the clinical development plan
- Responsible for preparing clinical documents and responses to health authorities and ethics committees for ongoing programs in support of development objectives and to ensure timely registration and initiation of clinical trials globally
- Drive translational strategy and early clinical development for our therapeutic programs, paving a roadmap by leveraging translational sciences to support Go/No Go decisions for the therapeutic hypotheses
- Establish and implement exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators
- Interact with patient advocacy groups, study investigators, experts, including advisory boards, academicians, and internal colleagues
- Participate in the evaluation of licensing opportunities and assessment of their compatibility with the existing portfolio
- Ensure adherence to Sangamo's Standard Operating Procedures; maintain knowledge of national and international guidelines including ICH/Good Clinical Practice
- Maintain clinical and scientific awareness in area of expertise
- An M.D. or combined M.D. / Ph.D.
- 5+ years of industry experience designing, leading and managing clinical studies.
- Experience in rare disease or genomic medicine. CNS translational/preclinical expertise preferred.
- Demonstrated understanding of the drug development process
- Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory / ICH requirements
- Ability to effectively evaluate outside expert advice
- Ability to communicate and explain technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background
- Ability to work independently
- Experience working effectively in a fast-paced, team-based environment
Sangamo is an equal opportunity employer
- Strong clinical/scientific/technical skills
- Strong interpersonal capabilities
- Ability to anticipate and resolve problems effectively
- Strong verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
- Sound organizational skills
- Sense of urgency; ability to identify challenges and problems and take the initiative to identify solutions
- Ability to motivate team members, foster and nurture teamwork
- Utmost focus on delivery of results
- Ability and willingness to travel at least 20% of the time (domestic & international)
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
The anticipated salary range is for candidates who will work in our Brisbane or Point Richmond, CA offices. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.
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