Head of Franchise Gynecological Oncology, Clinical Development jobs in United States
cer-icon
Apply on Employer Site
company-logo

Allergan Aesthetics, an AbbVie Company · 1 month ago

Head of Franchise Gynecological Oncology, Clinical Development

AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. The Head of Franchise Gynecological Oncology in Clinical Development will manage medical and scientific directors, oversee clinical trials, and ensure high-quality clinical data supporting product strategies.

BeautyManufacturingPharmaceuticalWellness
check
H1B Sponsor Likelynote

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
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
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

Qualification

Medical Doctor (M.D.)Clinical trial experienceClinical trial methodologyLeadership skillsRegulatory compliance knowledgeOralWritten communicationProblem-solving skillsTeam management

Required

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
At least 10 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
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
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
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

Preferred

Completion of a residency program strongly preferred
12+ years preferred of clinical trial experience in the pharmaceutical industry, academia, or equivalent
Deep therapeutic area expertise strongly preferred

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs

Company

Allergan Aesthetics, an AbbVie Company

twittertwitter
company-logo
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.

H1B Sponsorship

Allergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
linkedin
Company data provided by crunchbase