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Director, Medical Affairs NA
2 months ago
Title: Director, Medical Affairs NA – Biologics Lead
Sun Pharmaceuticals Industries Inc. is the fourth largest generic pharmaceutical company in the world, and rapidly building our brand presence. We manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.
At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values: Humility. Integrity. Passion. Innovation
Summary:
The Director, Medical Affairs NA - Biologics Lead will report to the AVP, Medical Affairs NA - Biologics and Market Access, and be a key medical resource in developing and implementing the medical affairs strategy for biologics. He/she will be responsible for the coordination of several medical activities linked to biologics in conjunction with the AVP, Medical Affairs NA - Biologics and Market Access. Among the responsibilities, the Director will actively participate in preparation and implementation of medical advisory boards, co-manage the phase IV clinical trials program with the clinical development leader, chair the investigator sponsored studies (ISS) team, help define strategies and tactics to support medical education programs, review medical and scientific content of promotional materials, maintain KOL relationships and serve as a consultant for Marketing, Health Outcomes, Access, Marketing & Sales, and participate in the development of medical strategies to appropriately position biologics as part of the Sun biologics portfolio..
Responsibilities:
This position reports directly to the AVP, Medical Affairs NA - Biologics and Market Access, and will manage multiple internal relationships within Sun Pharma. He/she will play a key role in external relationships include expert advisory board members, ISS investigators, patient advocacy groups, other consultants and key customer groups. He/she will contribute to biologics’ yearly medical affairs plan strategic and tactical implementation.
A. Communications/Training
Responsible for the creation of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, and field MSLs.
In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
Maintains required medical credentials and remains in good standing within the medical community and medical ethics boards.
Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of biologics, including reports and intelligence on new technologies or treatment advances
B. Medical Communications
Responsible for developing biologics-specific medical education strategy (CME, medical grants, professional societies), incorporates them into the medical affairs plans, and assesses their impact.
Participates in the development of biologics-specific publications strategy (primary, secondary, ad hoc and HEOR), working closely with the publication lead.
Responsible for support of external medical educations programs (CME).
Responsible for biologics-specific promotional materials as a key member of the Medical-Regulatory-Legal review team
C. Regulatory/Safety Activities
Responsible for the ongoing safety and adequacy of labeling of biologics from a medical perspective.
Participates in the interpretation of regulatory guidelines and directives to judge risk and causality.
Works closely with Clinical Development in selection of phase IIIb/IV investigators/sites, ensuring screening and accuracy, and guiding interpretation of results.
Assumes primary accountability as representative in Medical-Regulatory-Legal promotional team.
This role requires full knowledge of various Federal and Pharma regulations and guidelines as well as in depth knowledge of the biologics disease state.
Responsible for the medical definition and implementation of biologics’ labeling strategy
D. Sales/Marketing Support
Participates in presenting biologics’ clinical data at regional and national advisory boards.
Responsible for providing medical input to biologics’ market shaping strategy, marketing plans and promotional campaigns.
Responsible for medical input to commercial advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed.
Participates in the development of medical product support and development plans for biologics in concert with Sales and Marketing.
Plays an active role in ongoing sales and marketing objectives by assisting in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees.
Responsible for the quality and deliverables from Medical Information to assure that communication from Sun Pharma is scientifically accurate and clinically appropriate
STRATEGY AND PROTOCOL DEVELOPMENT
Participates in developing and executing biologics-specific phase IV trial strategy including prioritization criteria, and incorporates into the medical affairs plans, formalizing templates and processes to streamline protocol design, as well as developing biologics-specific ISS strategy, including prioritization criteria, and support execution.
Active participation in providing medical input on biologics’ global clinical development plan.
Collaborates closely with the US HEOR group on biologics-related activities (providing input into early economic models/endpoints, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications), and presenting this back to the medical affairs teams.
Helps build relationships and maintain a strong KOL network.
Participates in discussions regarding local and global clinical trials.
Participates in global publication planning for biologics.
Responsible for medical/scientific input into biologics’ development and marketing strategies
WORKPLACE REQUIREMENTS
Based in Princeton, NJ
Travel 15-20% of the time
HYBRID work model - 3 days in office; 2 days remote
EDUCATION, EXPERIENCE, KNOWLEDGE and SKILLS
MD, PhD or PharmD
7-10 years or more of research or pharmaceutical industry experience, in the field of immunology and/or dermatology preferred, and able to manage direct reports
Strong strategic mindset, understanding of physician, patient and payer needs in a changing healthcare delivery environment
Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other medical affairs activities (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, continuing medical education)
Subspecialty training in dermatology, rheumatology or immunology preferred
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
