Medical Senior Director

Job Description

Job Description

Salary : Background

Background

The California Institute for Regenerative Medicine (CIRM) is the state’s Stem Cell Agency. We were created by the voters of California when they approved Proposition 71 in 2004, and renewed when Proposition 14 was approved in 2020, providing $5.

5 billion to invest in stem cell research in California. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell and regenerative medicine technologies.

CIRM is the world’s largest institution dedicated to helping people by bringing the promise of regenerative medicine closer to reality.

General Statement

CIRM is seeking research and development-oriented physician with solid scientific acumen who is excited by cutting-edge regenerative medicine technologies and wishes to take part in accelerating world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and World.

As a primary responsibility, the Medical Senior Director will manage a portfolio of regenerative medicine grants from first in human clinical studies to advanced clinical trials.

The successful candidate will work with an experienced and dynamic team, where an emphasis will be placed on advising completing clinical trials that inform both the safety and efficacy of the therapeutic modality.

The role will entail diverse interpersonal skills and make key contributions to the CIRM portfolio and strategic vision.

In this important position, the candidate will be interfacing with both internal and external stakeholders including the various CIRM groups including, Review, Grants management, Scientific Programs, Legal, Finance, and Access and Affordability, as well as external grantees, patient advocates, and key Opinion leaders.

Essential Functions

• Support the Therapeutics Development (TD) Vice President as the lead of CIRM mid to late development programs.
• Along with other relevant functional groups, help develop / refine the strategic development plan for CIRM therapeutics development grants and other potential emerging novel granting mechanisms.
• Provide clinical and scientific leadership and expertise in the design of clinical studies, regulatory know how to guide team members and grantees in advancing therapies to late-stage development.
• Ensure compliance with internal SOPs, ICH GCP, and other national and international regulatory requirements.
• Lead and participate in the analysis and interpretation of data, assist in reporting of study results including preparation of scientific summaries, abstracts, and manuscripts.
• Work with the TD VP, and all the CIRM groups / functions to deliver and drive timely completion of all activities related to early and late clinical development programs.
• Be a problem solver. Utilize novel and creative methods to resolve grantees projects challenges and the TD team various clinical development problems.
• Interface with the Access and Affordability team, assisting in clinical related topics to enable achievement of their goals and deliverables.
• Lend clinical expertise to all CIRM groups and specifically lead and execute on CIRM funded clinical trials data management plans including safety reporting along with the potential of long term follow up plans.

Supervision Received

The Medical Senior Director will report to the Vice President of Therapeutics Development.

Supervision Exercised

The Medical Senior Director will manage and provide general direction to the Therapeutics Development team.

Qualifications (Education and Experience)

• Education in medicine, Medical Doctor (MD), or the equivalent international education is required. Specialty and subspecialty training, as well as expertise in management of diseases through regenerative medicine solutions, such as chronic diseases in neurology, oncology, hematology, are desirable.
• 10 + years of experience in the biotech industry or pharmaceutical (desired) industry, including experience managing clinical trials or an academic clinical research background.
• Strong scientific background expert with experience in reviewing scientific and clinical protocol development and interpreting clinical trial data.
• Working knowledge of biostatistics, data management, and scientific and technical processes desirable clinical operations
• Clinical development experience therapeutic areas aligned with CIRM’s mission.
• Experience in building and maintaining effective relationships within an organization as well as with external key opinion leader, advisory boards, and other key external therapeutic area influencers desirable.
• Proficiency in English required.
• Team player who works collaboratively in a challenging team metrics environment
• Ability to work independently to resolve challenges and conflicts.
• Excellent written and oral communication skills
• Integrity, honesty, and highest ethical standards, and a strong sense of personal accountability are essential.
• Quickly adapt and provide innovative solutions to challenges as they present themselves.

Working Conditions

• Hybrid environment, required to work two days in the South San Francisco office and three days remotely. In-person attendance of organizational meetings and board, subcommittee, and working group meetings as required.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be willing to work in a high-rise building.
• Ability to operate standard office equipment.
• Be available to work outside of normal business hours.

Compensation

This position is expected to pay $270,000 - $300,000 which fits within the full salary range of $234,840 - $325,696 for the Senior Director job classification.

It is uncommon for an individual to be offered a salary near the maximum of the range for a position. Salary for this position will reflect the final candidate’s qualifications, experience, skills, knowledge, relevant education, and certifications, in addition to being aligned with the internal leadership peer group.

Required Application Documents

The following items are required to be submitted with your application. Applicants who do not submit the required items timely may not be considered for this job :

• Cover Letter
• Resume / CV

For any inquiries about the position sent to jobs@cirm.ca.gov, the e-mail should have the position title on the subject line.

Contact Information

Kathie Raftery

Email - jobs@cirm.ca.gov

Please direct requests for Reasonable Accommodations to the interview scheduler at the time the interview is being scheduled.

You may direct additional questions regarding Reasonable Accommodations or Equal Employment Opportunity (EEO) for this position to CIRM’s EEO Office.

• EEO Officer : Denise D’Angel
• Email : jobs@cirm.ca.gov
• California Relay Service : 1-800-735-2929 (TTY), 1-800-735-2922 (Voice) TTY is a Telecommunications Device for the Deaf and is reachable only from phones equipped with a TTY Device.

Equal Opportunity Employer

The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.

It is an objective of the State of California to achieve a drug-free workplace. Any applicant for state employment will be expected to behave in accordance with this objective because the use of illegal drugs is inconsistent with the law of the State, the rules governing Civil Service, and the special trust placed in public servants.

Benefits

Information on benefits afforded by membership in the California Public Employees’ Retirement System can be found on the California Department of Human Resources (CalHR) Salary and Benefits website.