Kevin - Hound, Author at BioNorth Recruiting

Medical Director Global Pharmacovigilance, CNS, Oncology or GI

Takeda

Global Pharmacovigilance

Role: Medical Director Global Pharmacovigilance, CNS, Oncology or GI

Location: Cambridge, MA

OBJECTIVES:

Support developmental programs, including both early and late stage development as required.
Responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.
Supporting Therapeutic Lead
Line management responsibilities for junior physicians and/or scientists
Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

ACCOUNTABILITIES:

Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
Company wide safety expert for his/her compound responsibilities
Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed.
Serving in a leadership capacity for complex and strategically important programs
Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
Training and mentoring of Pharmacovigilance Physicians and Specialists
Perform activities required to serve as Global PV physician:
Review and oversight of safety data, both non-clinical and clinical
Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
Interactions with external experts and regulatory agencies and partner/co-development companies
Review of safety data and participate in dose escalation decisions
Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
Maintain professional knowledge and accreditation by active participation in continuing medical education activities

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Qualified physician (License, e.g. GMC registered, preferred)
Knowledge of principles of epidemiology and statistics.
Critical thinking and analytical skills and ability to make high level decisions
Excellent oral and written communication skills including ability to present to large internal/external groups
Good level of computer literacy with Microsoft applications

TRAVEL REQUIREMENTS:

5-10 times per year including international travel.

by Kevin - Hound

Senior Medial Director, Clinical Development, Inclacumab

GLOBAL BLOOD THERAPEUTICS

SENIOR MEDICAL DIRECTOR, CLINICAL DEVELOPMENT, INCLACUMAB

REPORTING TO VP, CLINICAL DEVELOPMENT

LOCATION: SOUTH SAN FRANCISCO

Position Summary:

Global Blood Therapeutics is looking for an experienced physician, leader and innovative drug developer with passion and creativity and who places the patient at the center of everything they do.

The individual will be a self-starter with excellent leadership, communication (within and outside of the organization) and multi-tasking skills. They should have a strong experience with clinical study conduct, data analysis and health authority document preparation and interactions. This position will also afford the individual the opportunity for increasingly more responsibility and leadership roles encompassing strategic planning, broad portfolio product development and personnel management within the Clinical Development team.

Essential Duties and Responsibilities:

Clinical Lead for Sickle Cell Disease (SCD) Program clinical studies including adult and pediatric programs
Clinical point of contact for all study related matters including data gathering, analysis and interpretation, safety assessments, regulatory documentation and publications
Clinical lead for development and execution of Clinical Development (CD) plans for the SCD program and including contributing to scientific, clinical and publication planning.
Clinical lead in communications to senior management and governance committees on study progress and strategic updates
Perform responsibilities independently and exhibit proficiency at the Medical Director role
Support Health Authority document writing, review and interactions
Support Business Development efforts
Clinical leadership of other pipeline molecules as needed

Cross-Functional Team and People Management

Participate in Study Execution Team (SET) Meetings and represent Clinical Science in program sub-teams
Provide clinical leadership to support the training and monitoring of study sites
Review and provide guidance on appropriate personnel assignments and budgets
Where applicable, hiring, retaining and managing direct reports and clinical consultants

Clinical Development Planning

Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies
Stay abreast of internal and external clinical and SCD landscape developments and update Clinical Development functions
Participate in Health authority document preparation and interactions
Provide clinical input into the relevant therapeutic/disease area scientific state
Provide clinical input for transitioning new drugs/indications into clinical development

Clinical Development Plan Implementation

Provide clinical oversight of relevant studies and progress, including participation in Study Execution Team meetings, reviews of medical/safety data, CSR writing
Provide clinical leadership for study site interactions, fielding medical questions and conducting Investigator Meetings
Represents GBT through collaborations with internal and external partners such as investigators, clinicians, scientists and key opinion leaders
Collaborate with Statistics to ensures appropriate medical/scientific data interpretation for study reporting and health authority interactions
Lead, or otherwise develops and provides, clinical science input into annual and strategic lifecycle plans

Qualifications:

Demonstrated proficiency in the Medical Director role
MD degree or MD, PhD degrees.
5+ years of drug development experience for the Medical Director and 6-7+ for a Sr. Medical Director
Must be board certified in medicine; optimally in hematology and/or pediatrics
Experience in writing and submission of Health Authority documents including IND and desirably NDA and pediatric investigational plans
Have strong cross-functional team leadership skills
Ability to work independently and in a fast paced, hands-on, growth-oriented work environment

Fit with GBT culture:

Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
Values-based leadership consistent with GBT's Core Values
Excitement about the vision and mission of GBT
Flexibility
Integrity

by Kevin - Hound

Sr Medical Director, Women’s Health

AbbVie – Sr Medical Director, Women’s Health

Hiring manager: Andy Campbell, Executive Medical Director Women’s Health and Virology

Location: Lake County, IL

Key Responsibilities Include:

Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a complex clinical research program independently.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.
Ability to exercise judgment and address complex problems and create solutions for one or more projects.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Travel:

Additional Information

Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time

by Kevin - Hound

Medical Director or Sr Medical Director, Oncology Global Medical Affairs

AbbVie

North Chicago, IL

Medical Director or Sr Medical Director, Oncology Global Medical Affairs

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 28,000 people worldwide and markets medicines in more than 170 countries.

Description

Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Collaborate with R&D and clinical development teams to support product development. Works closely with marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.

Key Responsibilities Include:

•Develop global medical affairs plan for product life cycle management.

•Responsible for timely execution of medical affairs plan within budget.

•In cooperation with affiliate / regional medical teams, marketing, regulatory, clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.

•Collaborate with internal stakeholders (R&D, commercial, regional medical teams) and external stakeholders (key opinion leaders, advocacy and cooperative groups).

•Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders).

•Represent at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with key opinion leaders.

•Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global concepts/protocols and their reports across different products.

•Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to conduct on clinical studies.

•Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.

•All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.

•Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identified training needs.

•Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia.

•Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.

•Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serves as the scientific team interface for key regulatory discussions.

•Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function.

•Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

• Ability to work independently. Can address complex problems within discipline or across several projects that require analysis of situation or in-depth evaluation of various complex factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.

Basic:

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.

• National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal). Completion of residency and/or fellowship is preferred.

•Minimum of 5-7 years of Medical Affairs and/or research and development experience in the biotech/ pharmaceutical industry. 7+ years of experience is preferred.

•Must have an in-depth understanding of Medical Affairs role and process.

•Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex clinical program independently.

•Good knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have an understanding of Pharmacovigilance practices for Clinical Development program.

•Ability to interact externally and internally to support global business strategies.

•Strong understanding of the pharmaceutical business.

•Must possess excellent oral and written English communication skills.

•Ex-Us: At least one further major international language is preferred.

•Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory.

by Kevin - Hound

Sr Medical Director, General Medicine

AbbVie – Sr Medical Director, General Medicine

Hiring manager: Joel Melnick, Executive Medical Director General Medicine

Location: Lake County, IL

Key Responsibilities Include:

Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a complex clinical research program independently.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Must possess excellent oral and written English communication skills.
Ability to exercise judgment and address complex problems and create solutions for one or more projects.

Additional Information

Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time

by Kevin - Hound

Senior Director, Development Design Center

AbbVie

North Chicago, IL

Title: Senior Director, Development Design Center

Hiring Manager: Kyle Holen, Head Development Design Center

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Purpose Statement:

AbbVie has developed a world class team to drive innovation in clinical trial design and execution. As the Sr. Director of the Development Design Center, you will lead a team of design and statistical directors responsible for reviewing the AbbVie portfolio. The Sr. Director will provide leadership to the team in addition to working across Therapeutic Areas for the Development organization to promote the use of real world data and predictive analytics to create more robust clinical programs. He or she will also be responsible for the long term strategy to facilitate interactions between Asset Development Teams, Innovative Statistics, Clinical Operations Therapeutic functions and the Development Design Center.

Major Responsibilities:

Manage, develop, coach both design directors and statistical directors
Provide strategic leadership to therapeutic area teams regarding the optimization of design and execution of clinical programs
Serve as a thought leader and trusted business partner to clinical teams, senior management and key stakeholders
Provide expert scientific consultation to Development by providing real time feedback on the impact of study design choices on costs, timeline, patient selection and recruitment for AbbVie portfolio.
Provide leadership and coordinate the review and leverage of global data resources to impact study design.
Influences and strategically manages linkages across business and understands the impacts of business decisions and solution
Champion of innovation and relentless strive to bring new technology and methodology to clinical development
Works with the Head of the DDC to ensure executive leadership has insight into DDC priorities and gathers key stakeholder feedback.

Qualifications:

Basic:

Required: Masters, Preferred: MD,PhD with extensive experience in drug development and clinical trials
At least 5 years of leadership experience related to clinical research and drug development within the pharma/biotech industry.
In depth drug development and scientific project leadership or related experience across all phases of drug development
Experience with large data sets and analytical skills to interrogate the data
Recognized as an expert with global knowledge of pharma drug development processes
Demonstrated leadership skills with broad scientific, strategic and business-related orientations
Requires multi-faceted, broad-based experience in multiple functions. Considered to have in depth knowledge of drug development issues and business needs.
Extensive experience in building, coaching and managing high level professionals and ability to bring out the best in others
Excellent interpersonal skills. Ability to interact externally and internally to support business strategy.
Recognized ability to evaluate complex issues from multiple perspectives to ensure that balanced risk assessments are made

Key Leadership Competencies:

Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
Learns fast, grasps the 'essence' and can change the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a collaborative, learning environment, open to suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages to reality

by Kevin - Hound

Medical Director, Oncology

AbbVie

North Chicago, IL

Title: Medical Director, Oncology

Hiring Manager: Gary Gordon, DVP Oncology Clinical Development

Purpose Statement:

Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Major Responsibilities:

Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and/or other cross-functional teams and internal stakeholders.
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.

Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications:

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
3 years (5 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a complex clinical research program independently.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.
Ability to exercise judgment and address complex problems and create solutions for one or more projects.

by Kevin - Hound

Medical Director, Gastroenterology US Medical Affairs

AbbVie

Medical Director, Gastroenterology US Medical Affairs

Reporting to Hubert Doerfler, GI Therapeutic Area Lead US Medical Affairs

Location: North Chicago, IL

Purpose:

Has strategic and operational medical affairs responsibility for Humira (adalimumab) as well as GI pipeline compounds. Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.

Key Responsibilities Include:

Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
Oversees the conduct of clinical trials and is medically and scientifically accountable for interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Can address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors.
Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.

Basic:

Medical Doctorate (M.D.) degree or equivalent preferred, PhD acceptable for exceptional candidates
Relevant therapeutic specialty (Gastroenterology/Immunology) in an academic or hospital environment or in private practice. Completion of residency and/or fellowship is preferred.
Minimum of 3 years of medical affairs/clinical trial experience in the pharmaceutical industry or equivalent.
Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy.
Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
Must possess excellent oral and written English communication skills.
Travel requirements: approx. 25%, mostly US

by Kevin - Hound

Medical Director, Immunology Clinical Development

AbbVie

Locations: North Chicago, IL – Boston, MA – San Francisco, CA

Title: Medical Director, Immunology Clinical Development

Purpose Statement:

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Major Responsibilities:

Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB), and/or other cross-functional teams and internal stakeholders.
Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications:

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a clinical research program of moderate complexity with minimal supervision.
Ability to perform and bring out the best in others on a cross-functional global team.
Ability to interact externally and internally to support a global scientific and business strategy.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.

by Kevin - Hound

Executive Medical Director, Hematology Clinical Development

AbbVie

Executive Medical Director, Hematology Clinical Development

Hiring Manager: Gary Gordon – VP Oncology Clinical Development

Location: AbbVie HQ, North Chicago, IL

Job Description:

Manages 2 levels of Medical and/or Scientific Directors and leads the direction, planning, execution, and interpretation of clinical trials or research activities across several clinical development programs. May lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Acts as the overall leader of the Clinical Research function broadly across programs and disease areas. As a teacher and mentor, trains and guides both individuals and teams to help them execute effectively and achieve excellence in their assigned tasks.

Major Responsibilities:

Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Ensures that staff provides project-related education of investigators, study site personnel, and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches. Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines (along with Clinical Operations), and the review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical judgment in the assessment and reporting of serious adverse events per corporate policy and regulations for those programs for which responsible.
Provides or ensures clarity regarding the appropriate level for review and approval of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
Manages two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders.
Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level.
Acts as a senior-level liaison for opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVie’s reputation as an industry leader.
Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications:

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
At least 10 years (12+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Deep therapeutic area expertise strongly preferred.
Ability to prioritize across, and help others effectively lead, several complex clinical research programs.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
Prior experience as a direct or matrixed manager, with a demonstrated track record of training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
Must possess excellent oral and written English communication skills.
Ability to exercise judgment and address complex problems and create solutions across multiple projects.

by Kevin - Hound