Based in the San Francisco Bay Area, and reporting to the Sr. Vice President & Chief Medical Officer, the Director of Regulatory Affairs will be responsible for regulatory strategy and execution and have regulatory input into clinical development, manufacturing, and marketing and sales.

Specifically, the Senior Director/Director of Regulatory Affairs will be responsible for and participate in the following activities:

• Development of U.S. and international regulatory filings for oncology products. Manage all submission activities and take responsibility for the production of high quality regulatory filings. Working with U.S. and international regulatory agencies to assure compliance with government regulations regarding all aspects of drug development and approval of filings, including clinical, CMC and pre-clinical development.


• Lending regulatory perspective to the design, execution, and analysis of clinical trials so that the data collected will anticipate and address the questions that regulatory authorities are likely to present.


• Providing guidance and advice to senior management leadership to achieve goals related to regulatory timelines, worldwide regulatory strategy, clinical testing, quality assurance, manufacturing formulations, processes and methods, and commercial brand support. 


• Acting as a credible, influential and well respected spokesperson for interactions and negotiations with regulatory authorities on all matters.  

   
Qualifications

• An advanced degree (master’s, PhD, or equivalent) in scientific discipline; Regulatory Affairs Certification (RAC) desirable


• A minimum of ten years of regulatory affairs experience within the pharmaceutical or biotechnology industries. Experience in big pharma is preferred.


• Experience in the preparation and assessment of regulatory filings, including NDAs/BLAs and INDs, in the U.S. and Europe and will have participated in taking a drug through FDA approval and through product launch.


• Must have substantial regulatory knowledge of drug development, clinical trial requirements, design and analysis, manufacturing, compliance and quality assurance. 


• Experience with the FDA and corresponding international regulatory bodies is necessary, and pre-established relationships with the FDA would be highly beneficial. 


• Experience with DDMAC and the advertising and promotional process relevant to product commercialization is necessary. Oncology experience is important.


• Must be entrepreneurial by nature, have high energy, be flexible in approach, and be a team player who is willing to roll up his/her sleeves and contribute to all aspects of the business.


• Must be a strategic thinker and high potential individual with the ability to grow and advance in the company.


• Must have a results-oriented work ethic, a positive, can-do attitude, and a proven ability to build an effective organization by attracting and retaining high caliber personnel.  Effective leadership, people management and a team builder style are essential.


• Demonstrated excellent communication skills – written and verbal, as well as strong presentation skills.


• Possess sound judgment – highest personal values and ethical standards.

Compensation

An attractive compensation package will be offered to the successful candidate.  It will include a competitive base salary, incentive bonus and stock options.

Senior Director, Clinical Research and Development - Oncology

Overview:

Essential functions include, but are not limited to the following:

• Oversee the implementation of clinical projects and the management of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.


• Manage clinical personnel, including Clinical Project Managers, CRAs and contractors.


• Participate in strategic planning activities and the preparation of clinical development plans and budgets.


• Assist Regulatory Affairs in the preparation and review of U.S. and international regulatory filings.


• Assist in the recruitment of study centers and the development of strong working relationships with investigators.


• Participate in the designing of clinical studies, the development of protocols and the preparation of clinical and regulatory reports.

Requirements:

• Six or more years relevant  of industry Clinical research


• Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.


• Demonstrated proficiency in the implementation, monitoring and management of clinical trials.


• Demonstrated management and/or supervisory skills.


• Broad knowledge and cross functional understanding of clinical trial methodology.

Education: 

• M.D., required. Training in Oncology.

This position in the overall management of the clinical project team and with the development of clinical plans and implementation of clinical trials.

Executive Director, Global Clinical Research and Development-Oncology


Essential functions include, but are not limited to the following: 

• Oversee the implementation of clinical projects and the management of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.


• Manage clinical personnel, including Clinical Project Managers, CRAs and contractors.


• Participate in strategic planning activities and the preparation of clinical development plans and budgets.


• Assist Regulatory Affairs in the preparation and review of U.S. and international regulatory filings.


• Assist in the recruitment of study centers and the development of strong working relationships with investigators.


• Participate in the designing of clinical studies, the development of protocols and the preparation of clinical and regulatory reports.

Experience:

• Relevant Big Pharma Clinical research


• Boarded Oncology or Boarded eligible


• Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.


• Demonstrated proficiency in the implementation, monitoring and management of clinical trials.


• Demonstrated management and/or supervisory skills.


• Broad knowledge and cross functional understanding of clinical trial methodology.

Education:
      M.D., required. Training in Oncology.

Associate Director / Director Biostatistics - Clinical

Overview:

Leads the biostatistics function and personnel to develop and execute statistical strategy, design and analyses for clinical trials in all phases that establish the conditions essential for determining dose, safety, efficacy, and marketability of pharmaceutical and/or biological products. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Recruits, develops, and supervises project statisticians. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations.

Requirements:

Five to ten years of experience as a biostatistician supporting clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
- Management and statistical analysis of data obtained from Phase I – III clinical studies in support of US NDAs.
- Supervision of multiple senior-level statisticians preferred
- Direct experience with FDA/EU Authority preferred

Preferred Qualifications: Excellent oral and written communication skills. Familiarity with automated liquid handling systems (TECAN) is a plus. Amgen, South San Francisco is seeking an enthusiastic, highly motivated, and team-oriented candidate for the position of Associate Scientist in the Pharmacokinetics and Drug Metabolism (PKDM) group. Primary responsibilities of this position include:

1) design and execution of in vitro and in vivo drug metabolism studies for the identification of metabolites and the characterization of biotransformation pathways,

2) application of mass spectrometry technology for metabolite identification (LTQ Orbitrap and API4000 Qtrap) and quantification of drug (API3000/4000) in biological matrices, and

3) conduct of in vitro drug metabolism-related assays (DDI, TDI, reaction phenotyping, etc.) for the selection and advancement of drug discovery candidates. The incumbent will summarize data and present findings to departmental and multi-disciplinary teams.

In this role, you will be responsible for:

• Conducting salt selection and polymorph screening studies for development compounds


• Characterization of physical properties of compounds using analytical tools such as XRD, DSC, TGA, Raman etc.


• Addressing development challenges for drug substance and drug product related to solid form properties


• Maintaining and operating laboratory equipment and analytical instrumentation in the Solid Forms laboratory


• Design and execution of experimental programs to develop, optimize and scale-up crystallization processes for drug substances


• Co-ordinating with other groups within the company to ensure timely availability of Clinical Trial Materials


• Representing the group and provide technical expertise in cross-functional project teams


• Providing technical input for regulatory filings, partnership due diligence etc.

Preferred Qualifications:

• PhD in Physical Chemistry, Chemical Engineering, Chemistry or related fields


• 5+ years experience in the pharmaceutical industry working with small molecule new chemical entities (NCEs)


• Knowledge of crystal structures, polymorphism, phase transformations, amorphous compounds, and physical properties including the application of analytical tools (e.g. XRD, HPLC, IR, Raman, particle size)


• Expertise in crystallization development, scale-up and optimization from laboratory scale to pilot scale


• Experience in recommendation of solid forms for development based upon bioavailability, manufacturing complexity and solid-state attributes


• Experience applying statistical approaches in the design and analysis of experiments


• Familiarity with oral solid dosage forms is a plus


• Extensive understanding of other disciplines related to solid forms development


• Thorough understanding and training in GMPs and regulatory requirements, experience with INDs is a plus


• Keeps abreast of and implements state of the art methodology and technology


• Be able to conduct research and make high quality contributions both independently and as a member of multi-disciplinary teams under defined timelines


• Skilled at presenting data and strategy in scientific settings and team meetings


• Capable of motivating others and providing input for self-development


• Excellent leadership, communication, teamwork, organizational and problem solving skills

This position offers the opportunity to work closely with manufacturing through the product development and R&D cycle to insure manufacturability of products in extremely high volumes. There is high visibility to upper management and excellent promotional opportunities exist. Additionally, this is a true global company with opportunities to design products that improve the lives of people throughout the world. Prior experience managing a team of engineers and having full responsibility for program management, projects management, and budgeting is a requirement.

• Masters or PhD in an engineering discipline

• 8+ years experience in an engineering role with a medical device company

• Experience in medical devices and injection systems.

The Company is an early-stage privately-held medical device company, focused on developing innovative medical technologies for treating respiratory diseases such as COPD, cystic fibrosis and influenza. Located in the San Francisco Bay Area, The Companys offerings include durable, ultra-lightweight, ambulatory ventilator systems intended to improve the quality of life and mortality of patients with respiratory disorders. The company is focused on developing innovative medical technologies for treating respiratory diseases such as COPD, cystic fibrosis and influenza. The Company Technologies’ offerings include durable, ultra-lightweight, ambulatory ventilator systems intended to improve the quality of life and mortality of patients with respiratory disorders. With clinical trials underway, the company is realizing its vision of improving breathing function and quality of life to people throughout the world. This is an exciting time to become part of this dynamic business team.

Position, Location and Scope

This position represents a new addition for the company.  Currently, the area of Clinical Affairs is being led by the Clinical Sales & Marketing department, together with outside consultants and other internal resources.  The Company now is committed to bringing in a full time executive, who would be part of the executive staff, to lead the department of Clinical Affairs.  The position will be based at corporate headquarters and will either report to the Vice President of Technology or to the CEO, depending on the individual and experience level.

The Director/ VP of Clinical Affairs will be responsible for developing and executing clinical trial strategies as well as leadership and oversight of all U.S. clinical studies.  S/he will be responsible for the strategic planning phase through conducting and reporting of the trial results. This will include design and implementation of complex protocols, and training of site and internal staff and monitors in protocol specific procedures. 

Specific Responsibilities

•  Develop clinical strategies and implementation plans, in partnership with the CEO and the other members of the Company’s operating committee, that achieve the Company’s strategic goals, including in particular, establishing the Company’s products and methods as standard of care in all target markets.  Oversee implementation of all such plans to successful conclusion.


• Hands-on design, setup and management of the conduct of clinical trials and clinical studies for both pre-market and post-market activities in all target markets.


• Create and provide “hands-on” leadership to the clinical team for successful planning and execution of each clinical trial and clinical study.  Establish and manage clinical departmental functions, systems, documentation, and procedures for the successful conduct and audit of clinical studies.


• Establish and manage a clinical database that tracks treatment and outcomes of all patients treated with the Company’s products in both clinical trials and commercial usage, supporting the needs of  the departments of Technology and Advanced Development and Marketing/ Business Development.


• Ensure the Company has sufficient resources in place to provide expert, timely support of clinical trial needs.  Manage those resources to ensure their effectiveness.  (examples:  CRO’s)


• Recruit, initiate and oversee sites for clinical trials.  Ensure that resources, systems, documentation, training, monitoring, oversight, adverse event reporting, management and controls are in place and effective at each clinical trial site so that the studies go smoothly, that they comply with study protocols and that they support regulatory requirements (GCP, IDE, FDA, OUS agency, etc). 


• Maintain strong internal relationships.  Work closely with The Company Technologies heads of Marketing and Business Development, Product Development, Technology , Regulatory & Quality to ensure that, where possible or necessary; effective clinical projects are in place to support each departments’ respective strategic objectives.  Ensure that those projects produce successful, relevant results.


• Communicate extensively with the CEO and with peers so that they are aware of all key activities and issues that are being faced, or are anticipated, relative to Product and Process Development objectives.

Position Requirements

& Experience

• B.S. degree in any biological science or related field; advanced degree preferred. 


• At least (10) years experience working in clinical affairs with Acute and Chronic trials experience within the medical device industry, with at least five (5) years in a managerial capacity.


• Hospital setting experience is a must (ideally with physicians and patients undergoing respiratory therapy studies); home care setting experience is strongly preferred.


• Demonstrated knowledge in the design, organization, negotiation, start-up and process of clinical trials, both US, OUS and ROW.  Must have experience in protocol design, regulatory requirements (e.g. IDE submission and approval), clinical trial conduct, data collection, analysis and reporting.


• In-depth understanding and experience in leading and managing clinical teams in the running clinical trials to support filing of Class II / III, IDE governed medical devices and Technical Files for CE marking medical devices.


• Demonstrated work experience in all phases of medical device registration and approval, from pre- to post-launch. Including supporting publication and/or symposium presentations.


• Existing professional and scientific interfaces within professional societies and governmental regulatory agencies, especially the FDA. Experience with International Health Authorities preferred.


• Ability to be analytical and quantitative when evaluating clinical trial plans and progress.


• Demonstrated prior success in operating in a small company or entrepreneurial environment a requirement.

A leader in the medical device industry has a need for an Associate Director of Research and Development in their injection systems and drug delivery products design group. This is a very strong and growing company with a full pipeline of innovative products and a fast paced work environment. Experience with infusion systems, injectors, powered injection systems, syringes, transfusion or blood collection systems, or similar devices is an absolute requirement. Experience in combination devices is a big plus.

This position offers the opportunity to work closely with manufacturing through the product development and R&D cycle to insure manufacturability of products in extremely high volumes. There is high visibility to upper management and excellent promotional opportunities exist. Additionally, this is a true global company with opportunities to design products that improve the lives of people throughout the world. Prior experience managing a team of engineers and having full responsibility for program management, projects management, and budgeting is a requirement.

• Masters of PhD in an engineering discipline

• 8+ years experience in an engineering role with a medical device company

• Experience in medical devices and injection systems.

• Prior success and a desire to excel

Blue Shield of California is looking for a Program Director that will serve as Chief of Staff to the Chief Medical Officer.The Program Director to the Chief Medical Officer (CMO) is a newly created position. This position will report to the Chief Medical Officer, SVP of Health Care Services, and will work closely with other members of the senior leadership team to work on highly strategic projects, including business planning and analysis. 

This position will be responsible for working with leadership to identify and pursue value creation opportunities for cost of health care initiatives; and provide insights into the health care market and future trends.  The Program Director may also act as an advisor to the CMO by identifying, tracking and managing dashboard metrics; project plans and associated risks for resolution and consolidation; providing expert level consulting capabilities to the functional area to realize leaders’ strategic agendas.

Candidate Profile and Requirements
The Program Director must have strong strategic and operational analysis and planning skills; strong research and quantitative analytical skills; excellent in-person written communications skills and previous experience in business planning/analysis.  The primary areas of focus will be work surrounding the cost of health care initiatives and business and strategic planning.

Specific duties include:

• Oversees the functional budget and strategic planning.
• Develops business case for strategic projects to include business requirements, financial analysis, pro-forma development and cost/benefit analysis.
• Work with CMO and HCS leaders on COHC initiatives including but not limited to bed day reduction, emergency room utilization and onsite care management model; quality management, regional medical strategy/policy and Pharmacy Benefit Management model.
• Drive internal planning processes associated with the development of functional areas goals and priorities.
• Meet with leaders to determine core capabilities and develop strategies to capitalize on these capabilities.
• Supports the planning, management and execution of key business processes associated with strategic planning and tactical initiatives.
• Proactively identify and resolve issues of strategic importance to HCS and BSC
• Ensures the development of accurate monthly forecasts.

Attributes/Characteristics:
The Program Director must have experience interacting with senior leadership teams.  The successful candidate will possess the ability to synthesize data, prepare and present findings with succinct and persuasive conclusions and recommendations.  Additionally, the candidate will exercise good judgment, adapt to constantly changing priorities in managing a wide range of projects, and demonstrate ability to structure, drive and execute complex multi-disciplinary issues to closure with minimal direction.

Education
An undergraduate and MBA degree are required. A minimum of 10 years experience including but not limited to strategic planning and analysis is preferred.

Blue Shield of California is an Equal Opportunity Employer.