Associate Group Medical Director (MD) - Genentech

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Associate Group Medical Director (MD) - Genentech

Associate Group Medical Director (MD)

Job ID
1000029854

Requisition Number
09-1000029854

Location
South San Francisco, CA

Job Category
Drug Devt - Med/Clin Affairs.

Shift
N/A

Description

Associate Group Medical Directors are generally expected to:  
Build, develop and lead the staff and infrastructure necessary to deliver clinical development expertise and targeted outcomes for the assigned portfolio. Demonstrate effective leadership and management skills, following GNE processes and supporting the desired culture of GNE Clinical Development

Develop the clinical development strategy, working with staff members, cross-functional team members, other internal and external partners and stakeholders, for molecules and/or drugs, across the assigned portfolio. Includes providing expert leadership guidance and input into various GNE business planning processes, which includes LCM (Lifecycle Management) and LCPs (Lifecycle Plans) for all molecules and/or drugs in the assigned portfolio

Stay informed and abreast of the external landscape as it relates to assigned molecules, programs and the associated therapeutic area(s). Responsible for educating others internally and externally on relevant clinical developments as these may implicate or otherwise impact clinical development strategies, plans and programs in the assigned therapeutic area(s)

Oversee multiple trials, projects and/or other programs for the assigned portfolio to ensure all activities are completed on-time, on-target and within-budget

Expertly guide direct reports, other team members and partners in the execution and completion of their work:

Innovative and on-target clinical trial or other program design and development

FDA and other health authority filing completion, submission and monitoring and other ongoing communication and interactions

Identification and ongoing management of CROs (clinical research organizations) or other relevant trial sites and personnel

Ongoing liaison, communication and relationship-building with thought leaders, KOLs (key opinion leaders) and other external subject matter experts and influencers

Development and ongoing monitoring of patient registries

Monitoring and reporting of clinical trial results

Effectively represent Clinical Development on multi-disciplinary GNE teams, driving cross-functional teams in their clinical development strategies, execution and completion, which may include acting as a DSTL or assigning such responsibilities to his/her direct reports

Act effectively and efficiently in the role as "reviewer" or "consultant" on various internal review and decision-making committees. May lead therapeutic area review teams

Develop and maintain important relationships internally and externally to aide in the most effective and efficient processes and outcomes from the work of Clinical Development

Serve as a resource for final interpretation and approval of clinical data results. Directs communication of clinical data and may serve as an interface with GNE senior leadership

Effectively and efficiently complete special projects, as assigned or otherwise appropriate

Staff Leadership & Development

Participates in developing the therapeutic area's clinical development vision, strategy and strategic objectives

Works with his/her manager and peers to identify and ensure the appropriate implementation of the required infrastructure - organization design, clear roles and responsibilities, learning and development needs, technology resources, other tools and templates, external vendor partners and operating budgets

Where applicable/appropriate, may participate in the negotiation with and commissioning of external vendor partners to support certain elements of the therapeutic area's Clinical Development function

Assigns direct reports their projects and programs

Cascades strategic and other relevant goals and objectives, as well as expense budgets to his/her direct reports

Tracks departmental expense budgets to ensure compliance with agreed parameters

Leads recruitment, hiring and on-boarding activities for his/her staff member roles

Provides his/her direct reports with ongoing coaching, development and leadership; includes holding regular staff and one-on-one meetings to check interim progress and re-direct or fine-tune direction, as appropriate

Oversees his/her direct reports' work at all intervals to ensure on-time, on-target and within-budget results

Plays a leadership role in all formal and informal performance management and career development activities for his/her direct reports; leads GNE's Performance Planning & Review Process for his/her staff

Represents Clinical Development for the assigned portfolio to groups and individuals inside and outside of GNE; includes championing and sponsoring the work of his/her staff and department

Actively participates in various leadership and skill development programs or projects for his/her own continued professional development

Undertakes special projects, as assigned, that will help further the overall success and effectiveness of Clinical Development

Complies with all company HR policies & procedures and governing state/federal employment-related laws. Ensures the same throughout his/her staff

Clinical Development
Leads disease strategy planning and development for the assigned portfolio:

Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the assigned portfolio and/or other molecules, drugs or plans in the wider therapeutic area or beyond. Includes regular attendance at major scientific conferences, leadership of competitive intelligence activities and projects, and expert review of published scientific and clinical literature

Plays a leadership role in educating others internally and externally on relevant clinical developments as these may implicate/impact the assigned portfolio's clinical development strategies, plans and programs

Advises senior GNE leadership, peers, direct reports and others internally and externally on strategic clinical development issues and considerations

May represent Clinical Development on GNE core teams, may also lead relevant cross-functional sub-teams, and/or assign these responsibilities to his/her direct reports

Drives the teams' clinical development strategies as leader or advises direct reports when acting as team leaders

Oversees and guides creation of clinical development plans for all molecules and/or drugs within the assigned portfolio

Acts as a key contributor to or lead for peer review sessions relevant to the assigned therapeutic area; includes acting as a frequent reviewer on various internal GNE review committees

Acts as an expert advisor and consultant to various internal decision-making committees such as the PPC (Product Portfolio Committee), other GNE management and teams regarding clinical development strategic or implementation issues and lifecycle planning for the assigned portfolio. Includes guiding and overseeing clinical development inputs into various GNE business planning processes, such as LCM and LCPs across the assigned portfolio

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

Consults to GNE Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned portfolio. May serve on Joint Executive committees, which include other GNE partner functions as well as external collaborator personnel, or may assign such responsibilities to his/her direct reports

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

Where assigned post-marketing responsibilities, provides expert leadership input into brand and launch plans and other relevant commercial strategies. Anticipates commercial strategies and needs and proactively initiates activities to meet these.

Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities. Includes regularly acting as an expert participant and contributor on appropriate advisory boards

Conducts FDA and/or other health authority interactions with no supervision. Supports his/her direct reports and/or other Clinical Development staff members in their communications and interactions with the FDA and/or other relevant authorities, external groups or bodies

Clinical Trials & Programs

Responsible for design, execution and data interpretation of clinical trials and programs for the assigned portfolio:

Manages across multiple projects

Oversees direct reports in their work with GNE Regulatory Affairs and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings. Supports direct reports and/or GNE Regulatory Affairs on clinical development aspects of filings. Provides ongoing guidance and leadership to direct reports when acting as the clinical lead on Filing Teams. Monitors IND filings for across the assigned portfolio

Provides guidance to direct reports in the strategy, design and implementation of clinical trials and other programs for their assigned projects

Oversees design and development of trial protocols; including effective incorporation of cross-functional strategies and input into programs

Oversees development of product safety profiles

Supports direct reports as needed and ensures they gain alignment with various internal partners and stakeholders on goals and resource needs. Includes guiding direct reports and core team Project Team Leaders (PTLs) to establish appropriate budgets and other resource plans

Oversees development of key clinical sections of Investigator brochures

Guides direct reports in the identification of appropriate external investigators

Guides direct reports in converting clinical development plans into project implementation plans and provides leadership oversight of clinical trial implementation, ongoing monitoring and evaluation, interactions and communications with external investigators and others internally and externally. Regularly assesses project progress, monitors variances; includes providing guidance on participant registry strategies and plans

Reviews and approves clinical components of presentations for clinical trial investigator meetings

Provides ongoing guidance to direct reports, cross-functional teams, review and decision-making committees, and other GNE senior leadership on the overall strategy and prioritization of clinical development activities across the assigned portfolio

Serves as a resource for issue management and resolution. Anticipates issues and helps prevent and/or resolve these

Where assigned post-marketing responsibilities, directs others in implementing Phase IV strategies, studies, registries, communication and publication activities over a range of products within the assigned portfolio

Serves as a resource for final interpretation and approval of clinical data results. Directs communication regarding clinical data and may serve as an interface with GNE senior leadership

Leads direct reports and their projects in assimilation of safety and efficacy data into approval-directed FDA submissions

Keeps all partners abreast of developments throughout all applicable intervals and ensures the same approach is consistently taken by his/her direct reports

Oversees contributions to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to activities across the assigned portfolio

Has regular interaction with GNE Corporate Relations and/or Investor Relations

Oversees direct reports in timely, accurate and thorough close-out and internal reporting of completed trial status and results

QUALIFICATIONS & EXPERIENCE:
M.D.
Must demonstrate 8 or more years' relevant experience (with a minimum of 3 years' clinical trial experience in the biotech/pharmaceutical industry)
2 or more years' experience managing medical directors/clinical staff
Strong academic/teaching background is strongly preferred
Strong, relevant therapeutic area experience (as typically measured by 3 or more years' relevant experience)
In-depth understanding of Phase I - IV drug development
Considerable experience in 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
Has leadership responsibilities in major scientific and advocacy organizations, and on national standard-setting bodies. Has a significant influence on clinical practice and standard of care
Has considerable experience working with the FDA and other relevant agencies
Business travel is required

ABILITIES:
Clinical leadership: is recognized as a subject matter expert in his/her field (includes external recognition as an expert); able to evaluate, interpret and present highly complex data for a series of studies (prospective and retrospective); has made significant contributions to an organization's drug development (whether for Genentech or another organization); has identified and created clinical development strategies that have led to label-enabling product definitions
Has proven abilities to effectively lead and manage multiple staff members, projects and teams to successful conclusion. Has strong cross-functional team leadership skills and has consistently excelled as a cross-functional project team leader
Can build vision and strategy and lead others in the accomplishment of this
Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
Outstanding business acumen; knows the industry, GNE's business model & value proposition, key competitors and other marketplace factors/dynamics
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
Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
Comfort around all levels of management; has demonstrated managerial courage in past positions and responsibilities
Strong influencing skills; proven abilities to get things done without formal authority
Strong negotiation skills; is highly adept at identifying solutions that will meet the needs of all parties involved
Strong communication & presentation skills; exhibits professional maturity, confidence and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important business decisions
Outstanding orientation to team work: works collaboratively, effectively and efficiently with others internally and externally
Strong conflict management skills; proactively minimizes situations where conflict may arise
Strong conflict resolution skills; proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties
Strong financial acumen; capable of understanding complex analyses and planning for product valuations and project budgets
Demonstrates behaviors and values consistent with Genentech's Good Operating Principles

DIVISION:  Development - Medical Affairs
REQUISITION NUMBER:  09-1000029854

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