 |
|
|
|
| Job details |
|
| If you want to remember this job or apply at a later time, click Save job to save it to your personal folder. |
|
| Medical Director (MD) |
|
| Job ID |
1000029845 |
| Requisition Number |
09-1000029845 |
| Location |
South San Francisco, CA |
| Job Category |
Drug Devt - Med/Clin Affairs. |
| Shift |
N/A |
| Description |
Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the product pipeline and portfolio within the assigned therapeutic area(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities and projects, and review of published scientific and clinical literature
Is expected to represent Clinical Development on GNE core teams, as well as lead relevant sub-teams, as assigned
Develops and cultivates relationships with external partners and constituents such as clinical investigators, clinicians, scientists and KOLs, as well as multi-disciplinary partners and stakeholders in GNE Product Development, Research, Commercial, Legal and Regulatory
Can lead therapeutic area clinical development strategy discussions; and acts as a key contributor to peer review sessions, as well as a regular presenter at various internal review committees, as appropriate
Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy. Helps GNE Research and other Product Development partners/stakeholders to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects
May also consult to GNE Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio
Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs
Where assigned post-marketing responsibilities, provides input into brand and launch plans and other relevant commercial strategies. Anticipates commercial strategies and needs and proactively initiates activities to meet these
Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)
Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities. Includes playing a key role in the organization and delivery of successful expert advisory boards
Participates in FDA or other health authority interactions with little or no supervision from his/her manager
Clinical Trials & Programs
Works with GNE Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings. Supports GNE Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug's Package Insert. Acts as the clinical lead on Filing Teams. Monitors IND filings for all assigned molecules and programs
Provides clinical oversight for a variety of projects:
Works with a host of internal and external partners and stakeholders in the design and implementation of clinical trials for assigned molecules and drugs
Designs and develops trial protocols; including effectively incorporating crossfunctional strategies and input into programs Develops the product safety profile
Gains alignment with various internal partners and stakeholders on goals and resource needs. Includes working with core team Project Team Leaders (PTLs) to establish appropriate budgets and other resource plans
Develops key clinical sections of Investigator brochures
Plays a key role in the identification of appropriate external investigators
Produces clinical components of presentations at clinical trial investigator meetings; delivering high-quality presentations at such meetings
Where assigned post-marketing responsibilities, directs others in implementing Phase IV strategies, studies, registries and communication/publications' activities. Provides ongoing clinical development expertise and guidance to GNE Medical Communications, Medical Science Liaisons (MSLs), and GNE Health Economics
Converts clinical development plans into project implementation plans and leads clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally. Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such
Plays an important role in the development of disease and/or treatment registries. Includes developing strategies or plans to enable appropriate registry recruitment
Keeps all partners abreast of developments throughout all applicable intervals
Contributes to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to assigned molecules and/or drugs
May interact with GNE Corporate Relations and/or Investor Relations
Works closely with Clinical Operations to close-out clinical trials and complete internal reporting of trial status and results; including associated publications
Departmental Support & Personal Development
Participates in recruitment of new department staff members
Helps on-board, coach and mentor new and/or less experienced staff members
Participates in and/or leads special departmental projects
May support departmental planning and budgeting; helping his/her manager to gather data/analyses and prepare for departmental expense budgets or other departmental planning processes
Solicits ongoing internal and external partner/stakeholder feedback on his/her performance and uses to continuously fine-tune and hone his/her approach, work and results
Participates in various internal and external training or other development opportunities
Identifies and recommends process and other improvements; whether pertinent to his/her specific department and/or beyond
Prepares for and actively participates in GNE's Performance Planning & Review Process
Takes an active role in personal career development
Participates in various staff meetings, including regular one-on-one meetings with his/her manager
Management of Direct Reports
Where applicable if managing direct reports:
Directly manages assigned staff member recruitment and on-boarding
Oversees the work of direct reports to ensure on-time, on-target and within-budget results
Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
Provides formal performance assessment and development planning for all direct reports through GNE's Performance Planning & Review Process
Complies with all company HR policies and procedures, as well as state/federal employment-related laws
QUALIFICATIONS & EXPERIENCE:
M.D.
Must demonstrate 4 or more years' biotech/pharmaceutical industry experience OR be a recognized expert in the field
Strong academic/teaching background is strongly preferred
Strong background/experience with clinical trials (as typically measured by 2 or more years' experience)
Strong, relevant therapeutic experience (as typically measured by 3 or more years' relevant experience)
In-depth understanding of Phase I-III or Phase IV drug development. Broad understanding of post-marketing drug development
Broad experience the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Comprehensive understanding of product and safety profiles
Well-versed in medical aspects of FDA regulations
Previous people management experience is a plus
Business travel is required
ABILITIES:
Outstanding attention-to-detail
Clinical leadership: is regarded as an expert in his/her field, is highly respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results
Strong business acumen: has in-depth knowledge of the biotech/pharmaceutical industry, Genentech's specific business model and the multiple functions and roles involved in the company's drug development process. Effectively contributes to development of disease strategies and plans
Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
Strong interpersonal, 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
Outstanding written communication skills
Strong business presentation skills: highly effective at summarizing and presenting the key considerations and decision-points
Confident and competent when interacting with varying levels of internal/external management, thought leaders, KOLs, etc.: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
Strong orientation to teamwork
Strong cross-functional team leadership skills: has consistently excelled as a cross-functional project team leader
Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to successful outcomes)
Demonstrates behaviors and values consistent with Genentech's Good Operating Principles
DIVISION: Development - Medical Affairs
REQUISITION NUMBER: 09-1000029845 |
|
|
 |
| |
