Sr. Clinical Research Scientist, Product Development, CVRM

Genentech

Job Opportunity

We advance science so that we all have more time with the people we love. The Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.

Alongside the Clinical Science Leader (CSL)/Global Development Leader (GDL), the Senior Clinical Scientist leads the development of the clinical science aspects of the Clinical Development Plan (CDP) strategy and supports various deliverables for effective and efficient CDP execution for the molecule/indication. The individual in this role will work very closely with colleagues to support late stage programs in the Obesity/Metabolic space.

Senior Clinical Scientists perform their responsibilities with independence and with demonstrated leadership.

This position is located in San Francisco, CA or Boston, MA. Relocation benefits will not be provided.

Required

  • You hold a bachelor's Degree (life sciences); Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc).
  • You have 6+ years academic and/or industry experience, with a primary focus in late stage clinical development; you have the ability to independently carry out the majority of their study conduct responsibilities and clear evidence of independence with respect to clinical science oversight and setting out the clinical science strategy to the clinical sub team.
  • You have strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.
  • You have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP. Experienced in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements.

Preferred

  • You have a proven track record of leading and performing in a fast-paced, matrix environment; ability to work independently and influencing others with strategic decisions.
  • You have demonstrated experience working with a Study Management Team (SMT), including training, responding to clinical study queries and support on clinical activities.
  • You have experience active as a co-lead in collaboration with various stakeholders, including study investigators.
  • You have experience leading and mentoring others.
  • You have experience solving unique or unpredictable problems that might have an impact on the goals and objectives as set by the organization.
  • You have the ability to partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.
  • You have demonstrated Interpersonal skills: Strong verbal communication and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.

The expected salary range for this position based on the primary location San Francisco, CA is $157,600 – $291,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form.

Tagged as: Life Sciences

Qualifications

  • You have 6+ years academic and/or industry experience, with a primary focus in late stage clinical development; you have the ability to independently carry out the majority of their study conduct responsibilities and clear evidence of independence with respect to clinical science oversight and setting out the clinical science strategy to the clinical sub team
  • You have strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required
  • You have in-depth knowledge of cross-functional teams involved in the drug development process and can integrate multiple perspectives into the CDP
  • Experienced in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements

Benefits

  • The expected salary range for this position based on the primary location San Francisco, CA is $157,600 – $291,600
  • Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law
  • A discretionary annual bonus may be available based on individual and Company performance

Responsibilities

  • Alongside the Clinical Science Leader (CSL)/Global Development Leader (GDL), the Senior Clinical Scientist leads the development of the clinical science aspects of the Clinical Development Plan (CDP) strategy and supports various deliverables for effective and efficient CDP execution for the molecule/indication
  • The individual in this role will work very closely with colleagues to support late stage programs in the Obesity/Metabolic space
  • Senior Clinical Scientists perform their responsibilities with independence and with demonstrated leadership

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